[Translation] A randomized, open-label, multicenter, two-formulation, multiple-dose, parallel-design bioequivalence trial of paliperidone palmitate injection (3M) 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帕利哌酮酯注射液（3M）（受试制剂）与Janssen Pharmaceutica N.V的参比制剂棕榈帕利哌酮酯注射液（3M）（参比制剂，商品名：善妥达®）多次给药在稳态下的生物等效性。

[Translation]

To evaluate the bioequivalence of multiple doses of Paliperidone Ester Injection (3M) (test preparation) produced by Shijiazhuang Zhongnuo Pharmaceutical Co., Ltd. of Shijiazhuang Pharmaceutical Group and Paliperidone Ester Injection (3M) (reference preparation, trade name: Santoda®) produced by Janssen Pharmaceutica N.V. at steady state.

Start Date12 Feb 2025

Sponsor / Collaborator

CSPC ZhongNuo Pharmaceutical (Shijiazhuang) Co. Ltd.

ChiCTR2400092854

/ SuspendedPhase 4IIT

A multicentre, real-world study on the analysis of factors related to sustained treatment with domestically produced paliperidone palmitate injection

Start Date01 Dec 2024

Sponsor / Collaborator-

ChiCTR2400092341

/ SuspendedPhase 4IIT

A multicenter and real-world study on the efficacy and safety of paliperidone palmitate injection for schizophrenia

Start Date15 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Paliperidone Palmitate

100 Translational Medicine associated with Paliperidone Palmitate

100 Patents (Medical) associated with Paliperidone Palmitate

660

Literatures (Medical) associated with Paliperidone Palmitate

01 Apr 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

A comprehensive analytical model for predicting drug absorption in the olfactory region: Application to nose-to-brain delivery

Article

Author: Lambert, Pierre ; Deruyver, Laura ; Rigaut, Clément ; Goole, Jonathan ; Haut, Benoit

Nose-to-brain drug delivery offers a promising route for administering pharmaceutical substances directly to the brain. However, this pathway faces significant challenges, such as mucociliary clearance and enzymatic activity in the nasal cavity, which limit drug absorption. Although several formulation strategies exist to enhance drug solubility, diffusion across the airway surface liquid, and protection from enzymatic degradation, there is a lack of tools to systematically evaluate which strategy is best suited for specific molecules. To address this, we developed an analytical model of the olfactory region that integrates drug dissolution, diffusion through the mucus and periciliary layers, advection by mucociliary clearance, and enzymatic degradation. This analytical model allows to estimate the fraction of a drug, formulated as a powder and deposited in the olfactory region, that is indeed dissolved in the mucus and absorbed by the cells, and to identify the most influential physicochemical properties in the absorption process. To demonstrate the model's utility, we 3D-printed custom-made diffusion cells to measure experimentally the diffusion coefficients of caffeine, levodopa, and paliperidone palmitate, incorporating these values into our simulations. Based on these data, we predicted drug absorption levels and proposed strategies to optimise them. By applying the model to an existing formulation, we demonstrated that careful adjustments to a drug's properties can significantly enhance the fraction absorbed in the olfactory region. Additionally, we explored how the site of drug deposition, influenced by the delivery device, impacts absorption by affecting residence time in the olfactory region. Overall, our analytical model serves as a valuable tool for the development of effective nose-to-brain formulations and the selection of optimal administration devices, streamlining the process and reducing the need for extensive in vitro and in vivo testing.

01 Mar 2025·CANADIAN JOURNAL OF PSYCHIATRY-REVUE CANADIENNE DE PSYCHIATRIE

Article

Author: Agid, Ofer ; Remington, Gary ; Zipursky, Robert B. ; Kiang, Michael

Objectives:

The majority of patients with schizophrenia experience dramatic improvement in psychotic symptoms when treated with antipsychotic medication. Maintenance treatment can prevent relapses but problems with medication adherence limit effectiveness. Long-acting injectable antipsychotics (LAIs) provide an opportunity to establish adherence but challenges remain in ensuring that the dose selected is therapeutic. Therapeutic drug monitoring has not been established as valuable for LAIs in the maintenance treatment of schizophrenia. This exploratory study was undertaken to describe plasma paliperidone levels in outpatients treated with the LAI paliperidone palmitate and to determine whether paliperidone levels are associated with subjective experience on medication and side effects.

Methods:

Twenty-one outpatients with schizophrenia receiving treatment with LAI paliperidone consented to participation in this study. Blood samples were obtained for measurement of paliperidone and prolactin levels at the first visit. A second paliperidone level was obtained at the time of the next injection for 18 of the participants. Clinical rating scales were administered at the first visit to assess illness severity, attitudes regarding medication, subjective well-being and side effects.

Results:

Paliperidone levels were highly correlated at the two time points (ρ = .85; P < .001). Mean paliperidone level at the first visit was 34.9 ng/ml and ranged from 5.1 to 73.9 ng/ml. Higher paliperidone levels were correlated with higher prolactin levels (ρ = 0.59, P < .01) and lower sexual desire (ρ = −.58, P < .01).

Conclusions:

We demonstrated that paliperidone levels can be measured reliably in patients receiving LAI paliperidone. Higher plasma levels were associated with higher prolactin levels and reduced sexual desire but not with measures of subjective experience on medications or other side effects. Measurement of paliperidone levels in patients treated with paliperidone palmitate may have the potential to minimize the dose of medication prescribed and, in turn, the severity of sexual side effects.

Plain Language Summary Title:

Can the Dosing of Long-Acting Injectable Paliperidone for the Treatment of Schizophrenia Be Improved by Measuring Drug Levels?

01 Mar 2025·JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY

Long-Acting Injectable Antipsychotic Initiation in Child and Adolescent Patients with Psychiatric Disorders

Article

Author: Goulding, Hannah ; Fabian, Tanya ; Yabs, Melanie ; Sun, Christina ; Clark, Christine ; Temelie, Andreea

Objectives: There are currently no long-acting injectable antipsychotics (LAIAs) that are approved by the Food and Drug Administration for use in child and adolescent patients, however these agents are used off-label for the treatment of various psychiatric disorders. This study aims to describe the initiation and maintenance dosing strategies of LAIAs in child and adolescent psychiatry inpatients. Methods: This was a single-site retrospective chart review of patients less than 18 years of age initiated on an LAIA during an acute psychiatric hospitalization between October 1, 2015, and October 31, 2022. Patient demographics and hospital encounter information were collected and analyzed using descriptive statistics. Results: Of the 6402 unique pediatric patients discharged from the acute psychiatric hospital within the specified timeframe, 45 (0.7%) were newly initiated on an LAIA. The average age was 15.6 years (range 10-17), with a greater proportion of male (n = 26, 57.8%) and Black or African American (n = 27, 60%) patients. The LAIA agents prescribed included paliperidone palmitate (n = 21, 46.7%), aripiprazole monohydrate (n = 15, 33.3%), aripiprazole lauroxil (n = 7, 15.6%), haloperidol decanoate (n = 1, 2.2%), and risperidone microspheres (n = 1, 2.2%). Primary diagnosis via International Classification of Diseases-10 code at discharge included schizophrenia spectrum and other psychotic disorders (n = 19, 42.2%); bipolar disorder (n = 14, 31.1%); disruptive, impulse control, and conduct disorders (n = 6, 13.3%); autistic disorder (n = 5, 11.1%); and attention-deficit/hyperactivity disorder (n = 1, 2.2%). Seventeen patients (37.8%) received a loading dose regimen and/or a maintenance dose regimen that differed from adult package-insert dosing. The mean length of stay was 23.7 days, and 14 patients (31.1%) were readmitted to the psychiatric hospital within 6 months of discharge. The mean number of days to readmission was 71.9 days. Conclusions: This retrospective study is the first to focus on LAIA initiation and maintenance dosing strategies of multiple agents in both a child and adolescent patient population. Further research is required to evaluate the impact of LAIAs on clinical outcomes in this patient population.

News (Medical) associated with Paliperidone Palmitate

07 Apr 2025

·www.prnewswire.com

Luye Pharma Announces U.S. Launch of ERZOFRI® (paliperidone palmitate) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Schizoaffective Disorder

PRINCETON, N.J., April 6, 2025 /PRNewswire/ -- Luye Pharma Group today announced that ERZOFRI® (paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the U.S. for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder. ERZOFRI, administered once a month, delivers the active ingredient, paliperidone, through a long-acting, extended-release delivery system. It simplifies treatment by enabling single-dose initiation due to its unique 351 mg initiation dose. The currently prescribed monthly paliperidone palmitate long-acting injectable (LAI) requires two initiation doses, on Day 1 and Day 8. ERZOFRI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis. The most common side effects of ERZOFRI include injection site reactions, sleepiness or drowsiness, dizziness, feeling restless or like you need to move, and abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes. Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurrent relapses[1]. Non-adherence to medication is a major challenge in patients with such conditions. Failure of follow-up care after discharge significantly increases patients' non-adherence to prescribed medications, relapse and rehospitalization[2]. LAI antipsychotics, with a reduced dosage frequency compared to oral antipsychotics, effectively improve medication adherence and reduce the risk of healthcare providers not knowing if their patients fail to follow the prescribed dosage regimen[3]. ERZOFRI's approval by the FDA is based on the results of an open-label, randomized, multiple-dose, parallel-group study evaluating its pharmacokinetic (PK) profile and relative bioavailability at steady state versus an established paliperidone palmitate LAI drug for reference. The study demonstrated the bioequivalence of ERZOFRI to the listed drug at steady state (treatment day 8) without the need for a second initiation injection. Comparable total drug exposure and a safety profile consistent with the listed drug were established. In addition to the unique 351 mg/2.25mL initiation dose, ERZOFRI is available in single-use kits in the following strengths: 39 mg/0.25mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL. "This newly approved long-acting injectable antipsychotic for the management of schizophrenia can help address treatment initiation complexities and provides an exciting alternative to help patients reach their treatment goals." said Christoph U Correll, MD, Professor of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, New York, USA. Rongbing Yang, President of Luye Pharma Group, added: "Medication adherence and discontinuation present a major challenge in the treatment of schizophrenia and schizoaffective disorder. Using LAIs is effective in increasing medication adherence. ERZOFRI, with its simplified dosage regimen eliminating the need for a second dose when initiating treatment is expected to increase treatment adherence in the initial stage. Its commercial launch in the U.S. marks a major milestone in our commitment to addressing the unmet medical needs of patients in the U.S. The central nervous system is a key therapeutic area of focus for Luye Pharma, and we are committed to providing innovative therapies to combat mental disorders and expand treatment options." ERZOFRI® (paliperidone palmitate) extended-release injectable suspension INDICATIONS What is ERZOFRI® (paliperidone palmitate)? ERZOFRI is a prescription medicine given by injection by a healthcare provider and used to treat: schizophrenia in adults schizoaffective disorder in adults either alone or with other medicines such as mood stabilizers or antidepressants It is not known if ERZOFRI is safe and effective in children. IMPORTANT SAFETY INFORMATION FOR ERZOFRI (paliperidone palmitate) ERZOFRI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis. Do not receive ERZOFRI if you are allergic to paliperidone, risperidone, or any of the ingredients in ERZOFRI. What are the possible serious side effects of ERZOFRI? Cardiovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic Malignant Syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider right away or go to your nearest emergency room right away if you get any of the following signs or symptoms: high fever stiff muscles confusion sweating changes in your breathing, pulse, heart rate, or blood pressure Problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you get any of these symptoms: passing out or feeling like you will pass out dizziness feeling as if your heart is pounding or missing beats Uncontrolled body movements (tardive dyskinesia). ERZOFRI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ERZOFRI. Tardive dyskinesia may also start after you stop taking ERZOFRI. Problems with your metabolism such as: High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who are treated with ERZOFRI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight, or a family history of diabetes, your healthcare provider should check your blood sugar before you start treatment and during your treatment with ERZOFRI. Call your healthcare provider if you get any of these symptoms of high blood sugar during treatment with ERZOFRI: feel very thirsty feel very hungry feel sick to your stomach need to urinate more than usual feel weak or tired feel confused, or your breath smells fruity Increased fat levels (cholesterol and triglycerides in your blood). Your healthcare provider may check your cholesterol and triglyceride levels during treatment with ERZOFRI. Weight gain. You and your healthcare provider should check your weight regularly during treatment with ERZOFRI. Decreased blood pressure (orthostatic hypotension) and fainting. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Falls. ERZOFRI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. Low white blood cell counts. Your healthcare provider may do blood tests during treatment with ERZOFRI. Increased prolactin levels in your blood (hyperprolactinemia). ERZOFRI may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection. Sleepiness, drowsiness feeling tired, difficulty thinking and doing normal activities. Seizures (convulsions). Difficulty swallowing that can cause food or liquid to get into your lungs. Prolonged or painful erection lasting more than 4 hours (priapism). Call your healthcare provider 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 so that you feel too warm. Before taking ERZOFRI, tell your healthcare provider about all of your medical conditions including if you: have never taken paliperidone or risperidone before have had neuroleptic malignant syndrome (NMS) have or had heart problems, including heart attack, heart failure, abnormal heart rhythm, or long QT syndrome have or had low levels of potassium or magnesium in your blood have or had uncontrolled movements of your tongue, face, mouth or jaw (tardive dyskinesia) have or had kidney or liver problems have or had high blood sugar, diabetes or have a family history of diabetes have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol have Parkinson's disease or a type of dementia called Lewy Body Dementia have or had problems with dizziness or fainting or are being treated for high blood pressure have or had a low white blood cell count have or had seizures or epilepsy are pregnant or plan to become pregnant. It is not known if ERZOFRI will harm your unborn baby. If you become pregnant during treatment with ERZOFRI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit . Babies born to women who are treated with ERZOFRI during their third trimester of pregnancy 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 provider know if these symptoms occur. are breastfeeding or plan to breastfeed. ERZOFRI can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you receive ERZOFRI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERZOFRI and certain other medicines may affect each other causing possible serious side effects or affect the way each other works. Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine. The most common side effects of ERZOFRI include: injection site reactions sleepiness or drowsiness dizziness feeling restless or like you need to move abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ERZOFRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at or call 1-800- FDA-1088. About Luye Pharma Group Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 20 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies. Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- China, the U.S., Europe and Japan, as well as in fast-growing emerging markets. SOURCE Luye Pharma Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalClinical Result

28 Mar 2025

·endpts.com

J&J beats Viatris in patent fight over its antipsychotic drug, staving off competition

Johnson & Johnson scored an appeals court win in its bid to block generic competition for its long-acting schizophrenia drug. The US Court of Appeals for the Federal Circuit on Friday affirmed a lower court ruling which had said that a generic from Mylan Laboratories (now part of Viatris) would induce healthcare providers to infringe claims in J&J’s dosing patent for the drug, called Invega Trinza. The claims cover a missed-dose regimen for a three-month paliperidone palmitate injection (PP3M), an antipsychotic used to treat schizophrenia. Invega Trinza’s dosing instructions track the patent claims and lay out a regimen for patients who had their last dose between four and nine months earlier, according to the decision. In its different forms, including Invega Trinza and Invega Sustenna, the drug brought in $4.2 billion in worldwide sales for J&J in 2024. “Intellectual property protections enable us to continue the discovery and development of the next generation of breakthrough treatments for patients,” a J&J spokesperson said in an emailed statement. “We believe in the strength of our intellectual property and will always defend our patents.” Viatris didn’t immediately respond to a request for comment. J&J sued Mylan after it sought FDA approval to market a generic version of Invega Trinza, with proposed labels that are substantially identical to Invega Trinza’s. Mylan had argued that its proposed labels couldn’t induce patent infringement because they discourage patients from missing doses in the first place. The proposed labels “explicitly instruct” providers to put patients back onto the PP3M using the asserted patent’s methodology, the Federal Circuit said. The court also upheld the lower court’s determination that Mylan failed to show that J&J’s patent is invalid. Editor’s Note: Story is updated with comment from J&J.

Patent Infringement

12 Feb 2025

·www.prnewswire.com

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025

— Total Revenues of $1.56 Billion in 2024; Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income from Continuing Operations of $372 Million and Diluted GAAP Earnings per Share from Continuing Operations of $2.20 for 2024 — — ALKS 2680 Phase 2 Studies in Narcolepsy Type 1 and Type 2 Ongoing With Data Expected in H2 2025 — DUBLIN, Feb. 12, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2024 and provided financial expectations for 2025. "2024 marked the completion of a multi-year effort to transition the business into a highly profitable, pure-play neuroscience company. We enter 2025 with a diversified portfolio of proprietary commercial products generating substantial profitability and an advancing development pipeline that represents a significant value creation opportunity in one of the most exciting potential new therapeutic categories in neuroscience," said Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, we are well positioned to deliver on our financial goals and advance the development programs for our portfolio of orexin 2 receptor agonists. This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia and advance ALKS 4510 and ALKS 7290 into planned phase 1 studies in disease areas beyond central disorders of hypersomnolence. Each of these initiatives is an important element of our strategy to unlock what we believe is a multi-billion-dollar market opportunity for this category." "2024 was Alkermes' strongest year of financial and operational performance to date. Financially, we generated more than $1 billion in revenue from our proprietary commercial product portfolio, delivered EBITDA from continuing operations of approximately $452 million, repurchased $200 million of the company's ordinary shares, retired approximately $290 million of debt and ended the year debt-free with approximately $825 million of cash and investments on the balance sheet. Operationally, we completed the sale of our manufacturing business in Ireland and made significant progress advancing our neuroscience development pipeline," said Blair Jackson, Chief Operating Officer of Alkermes. "We will continue to manage the business with a sharp focus on efficiency and profitability as we invest in the programs that we believe will drive the company's next phase of growth." Key Financial Highlights *As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the twelve months ended December 31, 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 fourth quarter were $77.0 million. Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023. During the quarter, the company recorded LYBALVI® revenue of approximately $4 million related to year-end inventory fluctuations. ARISTADAi Revenues for the fourth quarter were $96.6 million. Fourth quarter revenues grew 16% compared to the fourth quarter of 2023. During the quarter, the company recorded ARISTADA® revenue of approximately $9 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments. VIVITROL Revenues for the fourth quarter were $134.1 million. Fourth quarter revenues grew 31% compared to the fourth quarter of 2023. During the quarter, the company recorded VIVITROL® revenue of approximately $23 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments. Manufacturing & Royalty Revenues Royalty revenues from XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the fourth quarter were $36.5 million. VUMERITY® manufacturing and royalty revenues for the fourth quarter were $35.0 million. FAMPYRA® manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward. RISPERDAL CONSTA® manufacturing revenues for the fourth quarter were $14.7 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At Dec. 31, 2024, the company recorded cash, cash equivalents and total investments of $824.8 million, compared to $813.4 million at Dec. 31, 2023. In December 2024, the company prepaid and retired in full all of its outstanding long-term debt in the amount of approximately $290 million. Financial Expectations for 2025 All line items are according to GAAP, except as otherwise noted. Notes and Explanations 1. The company determined that upon the separation of its former 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 twelve months ended Dec. 31, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Wednesday, Feb. 12, 2025, 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, EBITDA and Adjusted 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. Adjusted EBITDA excludes share-based compensation expense in addition to the components of EBITDA from earnings. 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, EBITDA and Adjusted 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, EBITDA and Adjusted 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 expected drivers of growth, value creation 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; 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 unfavorable outcome of arbitration, litigation, or other proceedings or disputes related to the company's products or products using the company's proprietary technologies; 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 most recent Annual Report on Form 10-K 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 TRINZA®, RISPERDAL CONSTA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; FAMPYRATM is a trademark of Merz Pharmaceuticals, LLC; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 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 2

100 Deals associated with Paliperidone Palmitate

External Link

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	United States	Janssen Pharmaceuticals, Inc.	12 Nov 2014
Schizophrenia	United States	Janssen Pharmaceuticals, Inc.	31 Jul 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Central Sensitizations	Phase 1	United States	Luye Pharma Group Ltd.	08 Sep 2021
Mood Disorders	Phase 1	United States	Luye Pharma Group Ltd.	13 Jan 2021
Neurocognitive Disorders	Phase 1	United States	Luye Pharma Group Ltd.	13 Jan 2021

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02431702 \| NCT01157351 \| NCT01081769 (PRIDE \| PROSIPAL \| and DREaM, Pubmed \| J Clin Psychiatry)	Not Applicable	Schizophrenia	-	Paliperidone Palmitate (PP) long-acting injectable antipsychotic (LAI)	dtvudxebbm(tvlzuejvyg) = umyqjzcdcy bdbqcoxqwn (ynumujlwnr )	Positive	25 Sep 2023
				Oral Antipsychotic (OAP)	dtvudxebbm(tvlzuejvyg) = yipftvzlnv bdbqcoxqwn (ynumujlwnr )
NCT04072575 (CTgov)	Phase 3	Schizophrenia	178	Paliperidone Palmitate	abbnubkzrq = jbxlisjfvv bkgfdrpfyj (jphucjcycy, ynichjmeth - ydrtyuplab) View more	-	31 May 2023
NCT04922593 (Corporate Publications) Manual	Phase 1	Schizoaffective disorder \| Schizophrenia	281	LY03010	hembhkfxnn(pukcrxwcob) = 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® zjourosgrs (rnicpbjhbg ) View more	Positive	21 Nov 2022
				INVEGA SUSTENNA
NCT03345342 (CTgov)	Phase 3	Schizophrenia	841	PP3M (DB PP3M)	oyrxugirjr(wjcwdmrgqp) = uerruuycif lgbywjmxky (qmmceroqot, qgubmdutha - spwxkbcbyq) View more	-	09 Dec 2021
				placebo+PP6M (DB PP6M)	oyrxugirjr(wjcwdmrgqp) = rihkvnazvm lgbywjmxky (qmmceroqot, foeufobzbb - vcuuzrpgsa) View more
NCT01529515 \| NCT01515423 (Pubmed \| Braz J Psychiatry)	Phase 3	Schizophrenia	-	Paliperidone palmitate 3-monthly (PP3M)	iuqzdvrhro(ocobcwbnfc) = ishunyoosb wyurgcdlct (pkpifxccht )	-	01 Dec 2019
				Paliperidone palmitate 1-monthly (PP1M)	iuqzdvrhro(ocobcwbnfc) = dydcvvqdiu wyurgcdlct (pkpifxccht )
NCT01529515 \| NCT01515423 \| NCT01559272 (Pubmed \| Clin Pharmacokinet)	Not Applicable	Schizophrenia	651	Paliperidone Palmitate 3-month formulation	ozmryobreb(rnzxyosrlb) = yshmyedtuu meuxgupuji (apyhfxxbjt )	-	01 Apr 2017
NCT01515423 (Pubmed \| Int J Neuropsychopharmacol) Manual	Phase 3	Schizophrenia	1,016	paliperidone palmitate (PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal))	tgoihunnbp(mazbppzrtl) = sszodofavf dtrugsrhnk (whgrfpmemm )	Positive	05 Jul 2016
				paliperidone palmitate (PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal))	tgoihunnbp(mazbppzrtl) = dhutikhrhf dtrugsrhnk (whgrfpmemm )
NCT01515423 (CTgov)	Phase 3	Schizophrenia	1,429	Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 3 Month Formulation)	rzxeddjpuj = gdmzaekfsn gjulljfkuc (vsaysrtibr, alsgmoxigk - usmpoukmup) View more	-	02 May 2016
				Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 1 Month Formulation)	rzxeddjpuj = hyuezhnwwq gjulljfkuc (vsaysrtibr, qvqpheaenj - auaczrkvun) View more
NCT01559272 (Pubmed \| J Clin Pharmacol) Manual	Phase 1	Schizoaffective disorder \| Schizophrenia	328	paliperidone palmitate	erbeiluuez(mpqgptwxxq) = Headache and nasopharyngitis were the most common (>7%) arpcfjrupi (osaibnvkbj )	Positive	01 Mar 2016
NCT01081769 (Pubmed \| Schizophr Res) Manual	Phase 3	Schizophrenia	715	Paliperidone palmitate	orfciqvkjz(evizvoxiym) = ntbiefuqho kkdpdurqif (mfsxzckhbv ) View more	Superior	01 Dec 2015
				oral antipsychotics	orfciqvkjz(evizvoxiym) = puxpfiyfac kkdpdurqif (mfsxzckhbv ) View more

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