A Randomized, Open Label, Multicenter, Multiple Dose, Two Treatment, Two Period, Two Way, Crossover, Steady State Bioequivalence Study Between Paliperidone Palmitate Extended Release Intramuscular Injectable Suspension 156 mg per mL of Eugia Pharma Specialities Limited, India and INVEGA SUSTENNA Paliperidone Palmitate Extended Release Intramuscular Injectable Suspension 156 mg per mL Manufactured for Janssen Pharmaceuticals, Inc Titusville, NJ 08560, USA in Adult Patients with Schizophrenia or Schizoaffective Disorder. - NIL

Start Date20 Feb 2024

Sponsor / Collaborator

Eugia Pharma Specialities Ltd.

[+1]

CTR20233704 / RecruitingNot Applicable

棕榈酸帕利哌酮注射液（1M）在中国精神分裂症患者中进行的多中心、随机、开放、平行设计、多次给药生物等效性临床试验

[Translation] A multicenter, randomized, open-label, parallel-design, multiple-dose bioequivalence clinical trial of paliperidone palmitate injection (1M) in Chinese patients with schizophrenia

评价石药集团中诺药业（石家庄）有限公司生产的棕榈酸帕利哌酮注射液（受试制剂）与 Janssen Pharmaceutica N.V.生产的棕榈酸帕利哌酮注射液（参比制剂，商品名：善思达®）多次给药在稳态下的生物等效性.

[Translation]

To evaluate the bioequivalence of paliperidone palmitate injection (test preparation) produced by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and paliperidone palmitate injection (reference preparation, trade name: Susta®) produced by Janssen Pharmaceutica N.V. at steady state after repeated administration.

Start Date18 Dec 2023

Sponsor / Collaborator

Sinopharm Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., L

CTR20233833 / RecruitingNot Applicable

精神分裂症患者接受棕榈酸帕利哌酮注射液多次给药的随机、开放、双交叉、双周期、稳态人体生物等效性试验

[Translation] A randomized, open-label, double-crossover, two-period, steady-state bioequivalence study of multiple doses of paliperidone palmitate injection in patients with schizophrenia

主要研究目的：评价精神分裂症患者多次肌肉注射受试制剂丽珠集团丽珠制药厂研制的棕榈酸帕利哌酮注射液（代号：LZ1069）和参比制剂原研厂家 Janssen Pharmaceutica N.V.研制的棕榈酸帕利哌酮注射液（商品名：善思达®）达稳态后两者的生物等效性。次要研究目的：评价受试制剂和参比制剂在中国精神分裂症患者中多次肌肉注射的安全性和耐受性。

[Translation]

Main study objectives: To evaluate the bioequivalence of the test preparation, paliperidone palmitate injection (code: LZ1069) developed by Livzon Pharmaceutical Factory of Livzon Group and the reference preparation, paliperidone palmitate injection (trade name: Susta®) developed by Janssen Pharmaceutica N.V., after multiple intramuscular injections in patients with schizophrenia reached steady state. Secondary study objectives: To evaluate the safety and tolerability of the test preparation and the reference preparation in Chinese patients with schizophrenia after multiple intramuscular injections.

Start Date11 Dec 2023

Sponsor / Collaborator

Livzon Group Livzon Pharmaceutical Factory

100 Clinical Results associated with Paliperidone Palmitate

100 Translational Medicine associated with Paliperidone Palmitate

100 Patents (Medical) associated with Paliperidone Palmitate

567

Literatures (Medical) associated with Paliperidone Palmitate

30 Nov 2024·Clinical Psychopharmacology and Neuroscience

The Real-world Effect of Long-acting Injectable Antipsychotics on Annual Medical Costs of Korean Schizophrenia Patients.

Article

Author: Lee, Moon-Soo ; Han, Changsu ; Ko, Jeong Kyung ; Jeong, Hyung-Ghang ; Chi, SuHyuk

Objective:

Schizophrenia is a severe and chronic mental disorder that significantly impacts cognitive, social, and occupational functions, leading to substantial economic burdens. Long-acting injectable (LAI) antipsychotics have been introduced to improve treatment adherence and outcomes, yet their economic impact remains debated. We aim to analyze the impact of LAIs on the medical costs of Korean schizophrenia patients.

Methods:

A retrospective analysis of 164 schizophrenia patients treated with LAI antipsychotics, paliperidone palmitate, and aripiprazole monohydrate at Korea University Guro Hospital between January 2017 and July 2022 was performed. Comparisons of inpatient department (IPD) and outpatient department (OPD) healthcare expenditures one year before and after LAI initiation were conducted.

Results:

LAIs led to an increase in annual OPD costs (1,437.44 ± 1,127.60 to 4,015.42 ± 1,204.59; units: 1,000 KRW) but significantly reduced IPD admission associated costs (3,826.06 ± 5,500.63 to 698.06 ± 3,619.38; units: 1,000 KRW). After LAI administration, there was an overall reduction in total annual healthcare costs (5,263.49 ± 5,333.11 to 4,713.48 ± 3,625.89; units: 1,000 KRW), but it was not statistically significant.

Conclusion:

Although the use of LAIs did not significantly lower the first-year medical costs of schizophrenia patients, they offer beneficial economic impacts over time by reducing hospitalization-associated costs. Future research should focus on long-term cost analyses and the impacts of newer LAI formulations.

01 Sep 2024·Journal of Addiction Medicine

The Pharmacological Management of Ketamine Use Disorder: A Systematic Review

Review

Author: Guerrini, Irene ; Sanderson, Elizabeth ; Roberts, Emmert

Objectives:

There has been limited evidence synthesis examining treatment of ketamine use disorder. We aimed to conduct a systematic review to assess the efficacy and tolerability of pharmacological interventions in the management of ketamine use disorder.

Methods:

We searched MEDLINE, EMBASE, PsychINFO, and CENTRAL (Cochrane Central Register of Controlled Trials) from database inception to November 14, 2023, for studies of any design that reported on any pharmacological intervention in the management of ketamine use disorder. We extracted any reported measure of efficacy or tolerability and assessed outcome quality using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework. We planned to combine outcomes using random-effects meta-analysis, where this was not possible results were reported narratively.

Results:

Twelve studies met the inclusion criteria reporting on 368 participants. These comprised 1 controlled trial, 2 retrospective case series, and 9 case reports. Two studies reported on ketamine intoxication, 6 on withdrawal, and 4 on craving/relapse prevention. All studies reported only descriptive outcomes, and all evidence was of very low quality. Benzodiazepine regimens and haloperidol were reported to have potential utility in intoxication and withdrawal, whereas naltrexone, lamotrigine, and a combination of paliperidone palmitate and bupropion were reported to have potential utility in craving/relapse prevention.

Conclusions:

There is a paucity of research into pharmacological management of ketamine use disorder. The limited very low-quality evidence suggests benzodiazepine regimens may be most salient for future exploration in management of ketamine intoxication and withdrawal, whereas case reports suggest naltrexone, lamotrigine, and paliperidone palmitate plus bupropion may potentially merit further investigation with regard to craving/relapse prevention.

01 Sep 2024·Journal of Managed Care & Specialty Pharmacy

Treatment patterns and hospitalizations following rejection, reversal, or payment of the initial once-monthly paliperidone palmitate long-acting injectable antipsychotic claim among patients with schizophrenia or schizoaffective disorder

Article

Author: Lee, Inyoung ; Shaikh, Nazneen Fatima ; Patel, Charmi ; Zhao, Xiaohui ; Benson, Carmela ; Near, Aimee M. ; Wang, Yi

BACKGROUND:

Once-monthly paliperidone palmitate (PP1M) is a long-acting injectable antipsychotic approved for the treatment of schizophrenia and schizoaffective disorder (SCA) in adults.

OBJECTIVE:

To assess treatment patterns and schizophrenia/SCA-related hospitalization following payer rejection, patient reversal, or payment of an initial PP1M claim.

METHODS:

This was a retrospective cohort study using the IQVIA Formulary Impact Analyzer database linked to the Medical Claims, Hospital Charge Detail Master, and Experian consumer databases. Patients with schizophrenia/SCA and ≥1 PP1M pharmacy claim from January 1, 2018, to February 28, 2022, were identified and stratified into 3 cohorts based on the transaction status of the initial PP1M claim (index date): rejected (payer not approved), reversed (payer approved, patient abandoned), and paid (payer approved, patient filled). Patient characteristics during the 12 months before the index date, subsequent treatment patterns, and schizophrenia/SCA-related hospitalization for patients with >6 months of follow-up were assessed by cohort.

RESULTS:

The rejected, reversed, and paid cohorts included 1,260, 1,046, and 1,686 patients, respectively. Across these cohorts, the mean ages ranged between 39.2 and 44.5 years; more than half were male (50.8%-51.6%) and White (50.6%-58.3%); 19.8%-24.6% of patients had a Quan-Charlson Comorbidity Index score of ≥2. Rates of prior atypical oral and long-acting injectable antipsychotic use ranged between 76.4%-80.3% and 7.8%-12.7%, respectively. Among patients with ≥6 months of follow-up, 52.2% in the rejected and 53.1% in the reversed cohorts had a subsequent paid PP1M claim during the study period; the median (quartile 1-quartile 3) time to the first paid PP1M claim was 22 (5-74) days for rejection and 11 (1-41) days for reversal. In the rejected and reversed cohorts, 10.2% (n = 111) and 9.8% (n = 90) of patients, respectively, did not receive any paid claim for an antipsychotic after the initial PP1M rejection/reversal. The prevalence of schizophrenia/SCA-related hospitalization during follow-up was similar between patients with a paid (7.4%) and rejected PP1M claim (7.0%; P = 0.689) but higher among patients with a reversed claim (10.8%; P = 0.004). After adjusting for confounders, patients in the reversed cohort were 39% more likely to have a schizophrenia/SCA-related hospitalization than those in the paid cohort (odds ratio = 1.39; 95% CI = 1.03-1.87).

CONCLUSIONS:

Payer rejection and patient reversal of initial PP1M claims is a form of primary nonadherence and may influence patient trajectory. Data from this study suggest that patient reversal of PP1M may lead to an increased risk of schizophrenia/SCA-related hospitalizations, potentially caused by missed or delayed treatment. Policy initiatives that remove barriers to primary adherence or fulfillment may help improve patients' clinical outcomes.

News (Medical) associated with Paliperidone Palmitate

24 Oct 2024

·www.prnewswire.com

Johnson & Johnson highlights innovative neuropsychiatry portfolio and pipeline at Psych Congress

New five-year data reinforce long-term safety and efficacy of SPRAVATO® (esketamine) in patients with inadequate response to two or more oral antidepressants (treatment-resistant depression) 23 abstracts highlight data from Company's robust portfolio and pipeline, including clinical insights on major depressive disorder and the significant burden of anhedonia and insomnia symptoms Large real-world analysis highlights the link between reducing relapse and improving survival in schizophrenia TITUSVILLE, N.J., Oct. 24, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 23 abstracts featuring new real-world and clinical trial data from across its neuropsychiatry portfolio and pipeline will be presented at the annual U.S. Psychiatric and Mental Health Congress (Psych Congress), taking place October 29 to November 2 in Boston, Massachusetts. Presentations include new data supporting the safety and efficacy of SPRAVATO® (esketamine) CIII nasal spray and the Company's innovative portfolio of long-acting injectables (LAIs) for schizophrenia, as well as data highlighting the significant burden people living with major depressive disorder (MDD) and schizophrenia often face. "For nearly seven decades, J&J has been at the forefront of driving scientific progress and innovation in neuroscience," said Bill Martin, Ph.D., Global Neuroscience Therapeutic Area Head, Johnson & Johnson Innovative Medicine. "It is our responsibility and privilege to help advance research and understanding of MDD and schizophrenia so we can continue to deliver transformational therapies that address the greatest unmet patient needs." Key presentations include: New five-year, real-world safety data from nearly 35,000 adults treated with SPRAVATO®, building on more than a decade of research and reinforcing its well-studied, consistent safety profile (Poster 151). Novel insights into the clinical, humanistic and economic burden of anhedonia in adults with MDD (Poster 113). Results from an analysis of more than 30,000 adults with schizophrenia highlighting the link between symptom relapse and risk of death, which can occur 15‐20 years prematurely for adults living with schizophrenia compared to the general population due to many different causes.1 (Poster 42). "Serious mental illness is one of the most complex health challenges of our time," said Pearl Pugh, President, U.S. Neuroscience, Johnson & Johnson Innovative Medicine. "Understanding the patient experience is at the core of our mission to develop breakthrough solutions that can help improve care and make a difference in the lives of those living with challenging-to-treat mental illnesses." J&J will present the following posters at Psych Congress on October 31 from 1:30-3:30 p.m. ET and November 1 from 1:30-3:30 p.m. ET in the Exhibit Hall. ABOUT TREATMENT-RESISTANT DEPRESSION Depression is a common mental health disorder that impacts an estimated 280 million people worldwide.2 In the U.S., approximately 21 million adults have had at least one major depressive episode, and approximately one-third of medication-treated adults are considered to have TRD.3,4 People living with MDD are often considered to have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.4 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.4 ABOUT SPRAVATO® SPRAVATO® (esketamine) CIII nasal spray is approved by the U.S. Food and Drug Administration in combination with an oral antidepressant for adults with TRD and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. It is the first treatment to use a new mechanism of action in decades for the treatment of TRD. SPRAVATO® is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently by acting on a pathway in the brain that affects glutamate. To date, SPRAVATO® has been approved in 79 countries and administered to more than 100,000 patients worldwide. ABOUT MAJOR DEPRESSIVE DISORDER WITH INSOMNIA SYMPTOMS MDD is one of the most common psychiatric disorders and leading causes of disability worldwide,5 with an estimated 280 million people living with the disorder around the world.2 MDD is often accompanied by sleep disturbances such as insomnia or hypersomnia, affecting up to 60 percent of patients with MDD.6 Disturbed sleep and insomnia symptoms have a significant impact on a patient's quality of life and exacerbate the risk of depressive relapse and suicide.7,8 ABOUT SELTOREXANT Seltorexant, an investigational potential first-in-class therapy, is a selective antagonist of the human orexin-2 receptor currently being developed as an adjunctive treatment for adults with MDD with insomnia symptoms. Seltorexant is believed to selectively antagonize the orexin-2 receptors, potentially improving mood and sleep symptoms associated with depression. When orexin-2 receptors are stimulated for too long or at inappropriate times, their activation can cause hyperarousal manifestations, including insomnia and excessive cortisol release, which may contribute to depression and insomnia. ABOUT SCHIZOPHRENIA Schizophrenia is a chronic and severe brain disorder affecting approximately 20 million people worldwide and an estimated 2.4 million adults in the U.S.9-11 The disease is characterized by distortions in thinking, perception, emotions, language, sense of self, and behavior.9 It can also lead to neurological impairment and severe disability.12 Antipsychotic medication is recognized as an essential component in the treatment of schizophrenia, and adherence to medication plays a critical role in controlling symptoms and costly relapses.13 ABOUT J&J'S U.S. LONG-ACTING INJECTABLES The J&J U.S. portfolio of long-acting injectable treatments for adults with schizophrenia provides the most varied range of dosing options and the longest-lasting schizophrenia treatments with each dose available. Our portfolio includes INVEGA SUSTENNA® (1-month paliperidone palmitate), INVEGA TRINZA® (3-month paliperidone palmitate), and INVEGA HAFYERA® (6-month paliperidone palmitate), all of which are administered in a clinical setting by a medical professional. Long-acting injectables (LAIs) allow for the slow release of medicine into the bloodstream and have been available and studied for more than 50 years. Based on clinical guidance, the National Council for Mental Wellbeing and the American Psychiatric Association have updated their guidance and practice guidelines to recommend the use of LAIs for appropriate patients.14-16 SPRAVATO® IMPORTANT SAFETY INFORMATION What is SPRAVATO® (esketamine) CIII nasal spray? SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat: Adults with treatment-resistant depression (TRD) Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. It is not known if SPRAVATO® is safe and effective in children. IMPORTANT SAFETY INFORMATION Do not take SPRAVATO® if you: have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs) have an abnormal connection between your veins and arteries (arteriovenous malformation) have a history of bleeding in the brain are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®. If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®. Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you: have heart or brain problems, including: high blood pressure (hypertension) slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting history of heart attack history of stroke heart valve disease or heart failure history of brain injury or any condition where there is increased pressure in the brain have liver problems have ever had a condition called "psychosis" (see, feel, or hear things that are not there, or believe in things that are not true). are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant. Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®. If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®. There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at . are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®. Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects. Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicine. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How will I take SPRAVATO®? You will take SPRAVATO nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device. Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it. Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to. During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting. You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®. If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule. Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®. If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®. What should I avoid while taking SPRAVATO? Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See "What is the most important information I should know about SPRAVATO® ?" What are the possible side effects of SPRAVATO®? SPRAVATO® may cause serious side effects including: See "What is the most important information I should know about SPRAVATO?" Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®. Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering. Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night. The most common side effects of SPRAVATO when used along with an antidepressant taken by mouth include: If these common side effects occur, they usually happen right after taking SPRAVATO and go away the same day. These are not all the possible side effects of SPRAVATO®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. Please see full Prescribing Information , including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider. cp-170363v3 INVEGA® IMPORTANT SAFETY INFORMATION INDICATIONS INVEGA HAFYERA® (6-month paliperidone palmitate) is a prescription medicine given by injection every 6 months by a healthcare professional and used to treat schizophrenia. INVEGA HAFYERA® is used in adults who have been treated with either: INVEGA SUSTENNA® (paliperidone palmitate) a 1-time-each-month paliperidone palmitate extended-release injectable suspension for at least 4 months INVEGA TRINZA® (paliperidone palmitate) a 1-time-every-3-months paliperidone palmitate extended-release injectable suspension for at least 3 months INVEGA TRINZA® is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been adequately treated with INVEGA SUSTENNA® for at least 4 months. INVEGA SUSTENNA® is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used to treat schizophrenia in adults. IMPORTANT SAFETY INFORMATION Do not receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® ingredients. Before you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you: have had Neuroleptic Malignant Syndrome (NMS) have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome have or have had low levels of potassium or magnesium in your blood have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia) have or have had kidney or liver problems have diabetes or have a family history of diabetes have Parkinson's disease or a type of dementia called Lewy Body Dementia have had a low white blood cell count have had problems with dizziness or fainting or are being treated for high blood pressure have or have had seizures or epilepsy have any other medical conditions are pregnant or plan to become pregnant. It is not known if INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® will harm your unborn baby If you become pregnant while taking INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit . Infants born to women who are treated with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. are breastfeeding or plan to breastfeed. INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect the way other medicines work, and other medicines may affect how INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® works. Your healthcare provider can tell you if it is safe to receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® with your other medicines. Do not start or stop any medicines during treatment with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine. Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls. How will I receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®? Follow your treatment schedule exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much you will receive and when you will receive it. What should I avoid while receiving INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®? INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® affects you. Avoid getting overheated or dehydrated. INVEGA HAFYERA® , INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including: See "What is the most important information I should know about INVEGA HAFYERA® , INVEGA TRINZA® and INVEGA SUSTENNA®?" stroke in elderly people (cerebrovascular problems) that can lead to death Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure. problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing beats. uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia) metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain. low blood pressure and fainting changes in your blood cell counts high level of prolactin in your blood (hyperprolactinemia). INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection. problems thinking clearly and moving your body seizures difficulty swallowing that can cause food or liquid to get into your lungs prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours. problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration. The most common side effects of INVEGA HAFYERA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk. The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk. The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes. Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088. General information about the safe and effective use of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® for a condition for which it was not prescribed. You can ask your pharmacist or healthcare professional for information about INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® that is written for healthcare professionals. For more information, go to , or or call 1-800-526-7736. Please click to read the full Prescribing Information, including Boxed WARNING, for INVEGA HAFYERA ® , INVEGA TRINZA ® and INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional. cp-256259v4 ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and where solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. Correll C, Solmi, M, Croatto G, et al. Mortality in people with schizophrenia: a systematic review and meta-analysis of relative risk and aggravating or attenuating factors. World Psychiatry. 21(2),248–271. doi:10.1002/wps.20994 World Health Organization. Depressive disorder (depression). Accessed October 2024. who.int/news-room/fact-sheets/detail/depression National Institute of Mental Health. Major depression. Accessed October 2024. nimh.nih.gov/health/statistics/major-depression Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. (2021);82(2):20m13699. World Health Organization. "Depression: let's talk" says WHO, as depression tops list of causes of ill health. Accessed October 2024. Sakurai, H, Suzuki, T, Yoshimura, K, et al. Predicting relapse with individual residual symptoms in major depressive disorder: a reanalysis of the STAR*D data. Psychopharmacology. (2017);234(16): 2453–2461 . Psychopharmacology Institute. Understanding the relationship between insomnia disorder and MDD.. Accessed October 2024. Taddei-Allen, P. Economic burden and managed care considerations for the treatment of insomnia. Am J Manag Care. (2020);26:S91-S96. doi.org/10.37765/ajmc.2020.43008 World Health Organization. Schizophrenia. Accessed October 2024. Regier DA, Farmer ME, Rae DS, et al. One–month prevalence of mental disorders in the United States and sociodemographic characteristics: the epidemiologic catchment area study. Acta Psychiatr Scand. (1993);88(1):35-47. doi:10.1111/j.1600-0447.1993.tb03411.x US Census Bureau. 2010 US Census. Accessed October 2024. Andreasen N, Nopoulos P, Magnotta V, et al. Progressive brain change in schizophrenia: a prospective longitudinal study of first-episode schizophrenia. Biol Psychiatry. (2011);70(7):672-679. doi:10.1016/j.biopsych.2011.05.017 Higashi K, Medic G, Littlewood K, et al. Medication adherence in schizophrenia: factors influencing adherence and consequences of nonadherence, a systemic literature review. Ther Adv Psychopharmacol. (2013);3(4):200-218. doi:10.1177/2045125312474019 American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. Accessed October 2024. American Psychiatric Association. APA releases new practice guideline on treatment of patients with schizophrenia. Accessed October 2024. National Council for Mental Wellbeing. Guide to long-acting medications. Accessed October 2024. © Johnson & Johnson 2024. All rights reserved. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

24 Oct 2024

·www.prnewswire.com

Alkermes plc Reports Third Quarter 2024 Financial Results

— Third Quarter Revenues of $378.1 Million — — Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income from Continuing Operations of $92.8 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.56 — — Company Reiterates 2024 Financial Expectations — DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2024. "Our third quarter financial results reflect strong year-over-year growth of our portfolio of proprietary commercial products and position us well to meet our strategic, operational and financial priorities for the year. Looking ahead, we believe growing our proprietary commercial products and advancing our pipeline, particularly ALKS 2680, our novel, investigational, orexin 2 receptor agonist, and additional orexin development candidates, will serve as the key drivers of shareholder value. We plan to manage the business to deliver significant profitability and cash flow while investing in these strategic initiatives," said Richard Pops, Chief Executive Officer of Alkermes. "2025 has the potential to be a transformational year for Alkermes as we expect to complete the ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2, and prepare for potential registrational studies for ALKS 2680. With the potential to transform the treatment of hypersomnolence disorders, and with broad potential applicability across other symptomatic domains, orexin 2 receptor agonists represent one of the most exciting new therapeutic categories in development and we believe a significant opportunity for Alkermes and our shareholders." Key Financial Highlights *As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the nine months ended September 30, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods. Revenue Highlights LYBALVI Revenues for the quarter were $74.7 million. Revenues and total prescriptions for the quarter grew 47% and 37%, respectively, compared to the third quarter of 2023. ARISTADAi Revenues for the quarter were $84.7 million. VIVITROL Revenues for the quarter were $113.7 million. Revenues for the quarter grew 14% compared to the third quarter of 2023, driven by the alcohol dependence indication. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $58.4 million. VUMERITY® manufacturing and royalty revenues for the quarter were $32.6 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At Sept. 30, 2024, the company recorded cash, cash equivalents and total investments of $927.8 million, compared to $962.5 million at June 30, 2024. The company's total debt outstanding as of Sept. 30, 2024 was $288.8 million. Share Repurchase Program During the third quarter of 2024, the company repurchased approximately 4.4 million of the company's ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $115.6 million. As of Sept. 30, 2024, the company had $200 million (exclusive of any fees, commissions or other related expenses) remaining under the program. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In October 2024, the company hosted an investor event to review its portfolio of orexin 2 receptor agonists and development strategy. The company presented data from its ALKS 2680 phase 1b study in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), and discussed the study design for its ongoing phase 2 studies in NT1 and NT2. The company also announced its plans to initiate a phase 2 study in patients with IH in 2025. In September 2024, the company presented positive clinical data from its phase 1b study of ALKS 2680 in patients with NT2 and IH at the European Sleep Research Society's 27th Congress, Sleep Europe 2024. In August 2024, the company announced the initiation of its Vibrance-2 phase 2 study of ALKS 2680 in patients with NT2. In August 2024, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes' website. Notes and Explanations 1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and nine months ended Sept. 30, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, Oct. 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including drivers of shareholder value and profitability; and the company’s expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company’s other orexin portfolio candidates. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations, including those related to profitability; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. SOURCE Alkermes plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementPhase 1Phase 2Clinical Result

23 Sep 2024

·www.businesswire.com

Medincell’s Partner Teva Provided Treatment Insights into Switching to UZEDY® from Perseris®

MONTPELLIER, France--( BUSINESS WIRE )-- New data presented by Teva at ECNP 2024 * demonstrate switching to UZEDY at four weeks after the last dose of once-monthly Perseris ® (RBP-7000) provided the most comparable pharmacokinetic (PK) profile based on relevant simulations, with comparable doses identified. Perseris manufacturer announced in July 2024 the discontinuation of its commercialization. Teva already presented in June 2024 data informing clinical strategies for switching patients to UZEDY from a once-monthly intramuscular injection of Invega Sustenna ® (paliperidone palmitate) ** . Richard Malamut, Chief Medical Officer of Medincell said: “We are delighted to see that our partner is fully committed to supporting healthcare providers in implementing effective switching strategies to UZEDY, which offers several key differentiating features compared to other risperidone or paliperidone palmitate formulations: no loading doses or oral supplementation at initiation, flexible dosing intervals of either one or two months, subcutaneous administration, ready-to-use prefilled syringe.” About additional results from the Advance study on the utilization of long-acting injectable antipsychotics, which were also reported by Teva at ECNP 2024, Richard Malamut said: “ It is encouraging to see that most of the factors raised by patients with Schizophrenia, their caregivers, and healthcare providers regarding use of a long-acting injectable antipsychotic can be effectively addressed with UZEDY.” ACCESS HERE THE COMPLETE PRESS RELEASE * 37 th Annual European College of Neuropsychopharmacology (ECNP) Congress - September 21-24, 2024, Milan, Italy. www.ecnp.eu ** Medincell’s press release, June 3 rd , 2024: https://www.medincell.com/wp-content/uploads/2024/06/PR_MDC_Elevate2024_EN_vf.pdf About Medincell Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO ® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO ® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY ® (BEPO ® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities. UZEDY ® and SteadyTeq™ are trademarks of Teva Pharmaceuticals www.medincell.com

Drug ApprovalBiosimilar

100 Deals associated with Paliperidone Palmitate

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KEGG	Wiki	ATC	Drug Bank
D05340	Paliperidone Palmitate	N05AX13	DB01267

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Schizoaffective disorder	US	Janssen Pharmaceuticals, Inc.	12 Nov 2014
Schizophrenia	US	Janssen Pharmaceuticals, Inc.	31 Jul 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psychotic Disorders	Phase 3	US	Janssen Scientific Affairs LLC	08 Jul 2015
Psychotic Disorders	Phase 3	BR	Janssen Scientific Affairs LLC	08 Jul 2015
Psychotic Disorders	Phase 3	MX	Janssen Scientific Affairs LLC	08 Jul 2015
Central Nervous System Diseases	Phase 1	US	Luye Pharma Group Ltd.	08 Sep 2021
Neurocognitive Disorders	Phase 1	US	Luye Pharma Group Ltd.	13 Jan 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04072575 (CTgov)	Phase 3	Schizophrenia	178	Paliperidone Palmitate	fitvoeuqda(brryxauuju) = omsgijerrr kccuzcpzdi (vxcuotbrvj, hmapzgxayk - elnnsktrbw) View more	-	31 May 2023
NCT04922593 (Corporate Publications) Manual	Not Applicable	Schizoaffective disorder \| Schizophrenia	281	LY03010	qcvbvpigbj(hihowznsvl) = LY03010 has an optimized initial dosed regimen and is bioequivalent when stable state is reached with multiple doses compared to the initial dosed regimen of INVEGA SUSTENNA® anncjpvsyg (cjjvddaxpx ) View more	Positive	21 Nov 2022
				INVEGA SUSTENNA
NCT02713282 (REMISSIO, Pubmed) Manual	Phase 3	Schizophrenia	303	paliperidone palmitate (overall population)	clmfstrdki(askljwofgb) = rxuefcxrjw avgfcvupcn (iwelsikaal ) View more	Positive	31 Aug 2022
				paliperidone palmitate (Asian patients)	clmfstrdki(askljwofgb) = fsaznakoar avgfcvupcn (iwelsikaal ) View more
NCT03345342 (CTgov)	Phase 3	Schizophrenia	841	PP3M (DB PP3M)	ivwyzfqijb(wdmtskrwyw) = kgltvhxhio npbhueuekm (lpflfecbce, mkoxfdsfda - kfajcqjqyc) View more	-	09 Dec 2021
				placebo+PP6M (DB PP6M)	ivwyzfqijb(wdmtskrwyw) = qvhdukrxau npbhueuekm (lpflfecbce, lyghrntvqt - ggexslrosk) View more
NCT01529515 \| NCT01515423 (Pubmed \| Braz J Psychiatry)	Phase 3	Schizophrenia	-	Paliperidone palmitate 3-monthly (PP3M)	xayeqiegfd(cggfulgwxb) = ecjsuybfvj qzmdhhtvvc (hhowbjiukw )	-	01 Dec 2019
				Paliperidone palmitate 1-monthly (PP1M)	xayeqiegfd(cggfulgwxb) = fzfogcrrpg qzmdhhtvvc (hhowbjiukw )
EUCTR2011-004889-15-AT \| NCT01515423 (Pubmed \| Clin Drug Investig)	Phase 3	Schizophrenia	452	Paliperidone palmitate 3-monthly	bcfdftulki(dnpmlaztij) = cqcemlxwlk ujhckyhckd (gbvlyquvaj, -4.7 to 10.0)	-	01 Aug 2018
				Paliperidone palmitate 1-monthly	bcfdftulki(dnpmlaztij) = mzcsmxuuvk ujhckyhckd (gbvlyquvaj, -4.7 to 10.0)
NCT01157351 (Pubmed)	Phase 4	Chronic schizophrenia	450	Paliperidone palmitate	mvydjiycei(hcrdcqtwww) = recent-onset: 14% vs. 9%; chronic: 10% vs. 7% oixxflqvvc (axauzqgqlj ) View more	-	01 Feb 2018
				Oral antipsychotics
NCT01529515 \| NCT01515423 \| NCT01559272 (Pubmed \| Clin Pharmacokinet)	Not Applicable	Schizophrenia	651	Paliperidone Palmitate 3-month formulation	lxxtyjcnry(dxgcmslykv) = dnboleonmd flllypwpnh (vrhqrnegzt )	-	01 Apr 2017
NCT02918825 \| NCT01157351 (PRIDE, Pubmed)	Phase 4	Schizophrenia	444	Once-monthly paliperidone palmitate	wpmktqjmss(gcfdpvucju): HR = 1.34 (95% CI, 0.8 - 2.25) View more	-	01 Dec 2016
				Conventional oral antipsychotics
NCT01515423 (Pubmed \| Int J Neuropsychopharmacol) Manual	Phase 3	Schizophrenia	1,016	paliperidone palmitate (PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal))	bhkyunmifq(fluhuqymez) = bckvsvjtyq dirhnozeup (wjnbnfhviw )	Positive	05 Jul 2016
				paliperidone palmitate (PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal))	bhkyunmifq(fluhuqymez) = lbfhaaffct dirhnozeup (wjnbnfhviw )

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