[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.

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-

ChiCTR2400085792

/ RecruitingPhase 4IIT

A prospective cohort study of the efficacy and safety of paliperidone palmitate injection (PP1M) or oral paliperidone in adolescents with schizophrenia

Start Date18 Jun 2024

Sponsor / Collaborator-

100 Clinical Results associated with Paliperidone Palmitate

100 Translational Medicine associated with Paliperidone Palmitate

100 Patents (Medical) associated with Paliperidone Palmitate

659

Literatures (Medical) associated with Paliperidone Palmitate

01 Jun 2025·Neuropsychopharmacology reports

Treatment Persistence of Paliperidone Palmitate 3‐Month in Patients With Schizophrenia: A Japan Medical Data Center Claims Database Analysis

Article

Author: Wakamatsu, Akihide ; Chinen, Madoka ; Saga, Yosuke ; Chiang, Chih‐Lin ; Horio, Hiroshi ; Tokushige, Natsuko

ABSTRACT:

Aim:

To examine treatment persistence rates of paliperidone palmitate 3‐month (PP3M) for schizophrenia in Japan because evidence in real‐world settings is limited.

Methods:

A retrospective population‐based cohort study was conducted using the Japan Medical Data Center claims database. The overall cohort comprised schizophrenia patients aged ≥ 18 years, who received paliperidone palmitate 1‐month (PP1M) within 180 days before initiating PP3M. Of patients in the overall cohort, those who received PP1M ≥ 4 times within 180 days at 21–42‐day intervals with the same dosage strength as the last two PP1M doses before switching to PP3M initiated PP3M with a dose equivalent to 3.5‐fold the last PP1M dose and took no other concomitant antipsychotics within 112 days before initiating PP3M were included in the per protocol cohort (PPC). The Kaplan–Meier method was used to calculate PP3M persistence rates in the overall cohort and PP3M monotherapy persistence rates in the PPC.

Results:

In the overall cohort and PPC, 121 patients and 87 patients, with a mean age of 41.5 years and 48%–53% being employed, were followed up for ≤ 27 months. At 365 days and 730 days, the PP3M persistence rate was 76.9% and 71.7% in the overall cohort, and that for PP3M monotherapy was 73.1% and 64.6% in the PPC.

Conclusion:

Treatment persistence rates for PP3M in Japan were relatively high among schizophrenia patients transitioned from PP1M. High persistence rates can be achieved with PP3M monotherapy in patients who have been sufficiently stabilized with PP1M monotherapy prior to initiating PP3M.

01 May 2025·CPT-Pharmacometrics & Systems Pharmacology

Using the Simcyp R Package for PBPK Simulation Workflows With the Simcyp Simulator

Article

Author: Shireman, Laura ; Vinden, Barry ; Onasanwo, Anthonia M. ; McNally, Kevin ; Mittapelly, Naresh ; Craig, James ; Bois, Frederic Y.

ABSTRACT:

Physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) modeling aims to understand how a drug is absorbed, distributed, metabolized, excreted, and acts in a human or animal body. The Simcyp Simulator is a well‐known commercial PBPK/PD simulation software offering many options. It can, for example, use multiple compounds and population specification files to study the behavior of specific drug formulations in particular population groups. Such features can greatly speed up and optimize clinical research and drug development studies. On the other hand, the statistical coding language R offers benefits, such as easy scripting, automation, flexible statistical analyses, and visualization of results. These benefits can be applied to PBPK modeling. We describe here version 23.0.64 of an R software package that can run the Simcyp Simulator from R, changing its inputs and processing its outputs. We detail the implementation of two automated workflows for model development and verification. The first demonstrates the verification of a drug–drug interaction model for Atazanavir, an antiretroviral drug indicated for the treatment of HIV/AIDS. The second is applied to the virtual bioequivalence assessment of paliperidone palmitate long‐acting injectable suspensions. We show how simulations that could take days otherwise can be executed, analyzed, and displayed in a matter of hours.

01 May 2025·JOURNAL OF THE AMERICAN GERIATRICS SOCIETY

Use and Discontinuation Rates of Long‐Acting Injectable Antipsychotics Between Race/Ethnicity in Older Adults Using Medicaid Databases

Article

Author: Xu, Jianing ; Hall, Daniel B. ; Cassara, Christopher M. ; Chen, Xianyan ; Young, Henry N. ; Caballero, Joshua

ABSTRACT:

Objective:

The primary objective of this study was to assess the prescribing patterns of long acting injectable (LAI) antipsychotics in an older adult population. Secondary objectives were to determine if there were differences in treatment discontinuation rates between different LAI agents and race/ethnicity.

Methods:

Merative MarketScan Multi‐State Medicaid Databases (2017–2021) were used to identify patients 65 years or older who were prescribed a LAI antipsychotic. Pharmacy claims for LAI antipsychotics were referenced via National Drug Code (NDC) by brand/generic name and dose. International Classification of Diseases, 10th edition (ICD‐10) codes were used to identify older adults diagnosed with schizophrenia, schizotypal or schizoaffective disorders. Those with dementia or related disorders were censored. Conditional associations between race/ethnicity and generation of LAI antipsychotics were investigated using logistic regression controlling for age, sex, and health plan. Cox proportional hazard regression was used to compare the distribution of time until treatment discontinuation among older adults across LAI antipsychotics.

Results:

A total of 526 older adults (59% female) with an average age of 70.4 ± 5.5 years met inclusion for analysis. The most commonly used LAI antipsychotics included paliperidone palmitate‐1 month formulation (~35%), haloperidol decanoate (~24%), and risperidone microspheres (~15%). Overall, approximately 32% received LAI first‐generation antipsychotics and 68% received LAI second generation antipsychotics. Blacks (n = 204) received LAI first‐generation antipsychotics more often than Whites (n = 283); (OR: 1.74, 95% [1.18, 2.56], p < 0.01). When controlling for age, sex, and race/ethnicity, LAI first‐generation antipsychotics showed earlier discontinuation rates compared to LAI second‐generation antipsychotics (HR: 2.12, 95% CI [1.45, 3.10], p < 0.001).

Conclusions:

LAI first‐generation antipsychotics showed treatment discontinuation significantly earlier compared to LAI second‐generation antipsychotics. Furthermore, Blacks were prescribed LAI first‐generation antipsychotics at a higher rate than Whites, which may contribute to poorer health outcomes. Futures studies are needed to establish a causal relationship.

News (Medical) associated with Paliperidone Palmitate

01 May 2025

·investor.alkermes.com

Alkermes plc Reports First Quarter 2025 Financial Results

— First Quarter Revenues of $306.5 Million — — GAAP Net Income of $22.5 Million and Diluted GAAP Earnings per Share of $0.13 — — Company Reiterates 2025 Financial Expectations — DUBLIN , May 1, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the first quarter of 2025. "Our first quarter financial performance provides a solid foundation to deliver on our financial guidance for the year. We are in a strong position in this dynamic macroeconomic environment and remain focused on executing on the strategic objectives that we believe will drive the future value of the company," said Richard Pops , Chief Executive Officer of Alkermes. "We recently achieved an important milestone in the program for ALKS 2680, our novel, investigational, oral orexin 2 receptor agonist, completing enrollment in our first phase 2 study in the program, Vibrance-1, in narcolepsy type 1. We now expect topline results from Vibrance-1 early in the third quarter. We expect to complete enrollment in the Vibrance-2 phase 2 study, in narcolepsy type 2, mid-year, with topline data from that study expected in the fall. Enrollment in Vibrance-3, our phase 2 study in idiopathic hypersomnia, is now also underway. Across the ALKS 2680 development program, we have strong momentum and are preparing for the phase 3 program. With the potential to transform the treatment of central disorders of hypersomnolence, orexin 2 receptor agonists are one of the most exciting new therapeutic categories in development." Key Financial Highlights Revenues (In millions) Three Months Ended March 31 , 2025 2024 Total Revenues $ 306.5 $ 350.4 Total Proprietary Net Sales $ 244.5 $ 233.5 VIVITROL® $ 101.0 $ 97.7 ARISTADA®i $ 73.5 $ 78.9 LYBALVI® $ 70.0 $ 57.0 Profitability (In millions) Three Months Ended March 31 , 2025 2024 GAAP Net Income From Continuing Operations $ 22.5 $ 38.9 GAAP Net Income (Loss) From Discontinued Operations $ -- $ (2.1) GAAP Net Income $ 22.5 $ 36.8 EBITDA From Continuing Operations $ 22.8 $ 51.5 EBITDA From Discontinued Operations $ -- $ (2.5) EBITDA $ 22.8 $ 49.0 Adjusted EBITDA $ 45.6 $ 81.8 Revenue Highlights LYBALVI Revenues for the quarter were $70.0 million . Revenues and total prescriptions for the quarter grew 23% and 22%, respectively, compared to the first quarter of 2024. ARISTADAi Revenues for the quarter were $73.5 million . VIVITROL Revenues for the quarter were $101.0 million . Manufacturing & Royalty Revenues VUMERITY® manufacturing and royalty revenues for the quarter were $27.8 million . Royalty revenues from XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $17.7 million . Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. (In millions) Three Months Ended March 31 , 2025 2024 R&D Expense – Continuing Operations $ 71.8 $ 67.6 R&D Expense – Discontinued Operations $ -- $ 2.5 SG&A Expense – Continuing Operations $ 171.7 $ 179.7 SG&A Expense – Discontinued Operations $ -- $ -- Balance Sheet At March 31, 2025 , the company recorded cash, cash equivalents and total investments of $916.2 million , compared to $824.8 million at Dec. 31, 2024. Financial Expectations for 2025Alkermes reiterates its financial expectations for 2025, as set forth in its press release dated Feb. 12, 2025 . Notes and Explanations1. 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 months ended March 31, 2024 . Conference CallAlkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET ( 1:00 p.m. BST ) on Thursday, May 1, 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 www.alkermes.com. 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 www.alkermes.com. Non-GAAP Financial MeasuresThis 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 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. 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, 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, 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 StatementsCertain 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 value drivers; and the company's expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680. 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; 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 not agree with the company's regulatory approval strategies or may make adverse decisions regarding the company's products; 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 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, 2024 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 www.sec.gov. 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 HAFYERA®, 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. Alkermes plc and Subsidiaries Selected Financial Information (Unaudited) Condensed Consolidated Statements of Operations - GAAP Three Months Ended Three Months Ended (In thousands, except per share data) March 31, 2025 March 31, 2024 Revenues: Product sales, net $ 244,493 $ 233,536 Manufacturing and royalty revenues 62,017 116,833 Research and development revenue — 3 Total Revenues 306,510 350,372 Expenses: Cost of goods manufactured and sold 49,197 58,644 Research and development 71,817 67,611 Selling, general and administrative 171,704 179,749 Amortization of acquired intangible assets — 1,059 Total Expenses 292,718 307,063 Operating Income 13,792 43,309 Other Income, net: Interest income 10,141 9,399 Interest expense — (5,978) Other income, net 1,556 182 Total Other Income, net 11,697 3,603 Income Before Income Taxes 25,489 46,912 Income Tax Provision 3,025 7,964 Net Income From Continuing Operations 22,464 38,948 Loss from Discontinued Operations — Net of Tax — (2,120) Net Income — GAAP $ 22,464 $ 36,828 GAAP Earnings (Loss) Per Share - Basic: From continuing operations $ 0.14 $ 0.23 From discontinued operations — (0.01) Earnings per share $ 0.14 $ 0.22 GAAP Earnings (Loss) Per Share - Diluted: From continuing operations $ 0.13 $ 0.23 From discontinued operations — (0.01) Earnings per share $ 0.13 $ 0.21 Weighted Average Number of Ordinary Shares Outstanding: Basic — GAAP 163,407 167,984 Diluted — GAAP 168,737 172,981 Condensed Consolidated Statements of Operations - GAAP (Continued) Three Months Ended Three Months Ended (In thousands, except per share data) March 31, 2025 March 31, 2024 An itemized reconciliation between net income from continuing operations on a GAAP basis and Adjusted EBITDA is as follows: Net Income from Continuing Operations $ 22,464 $ 38,948 Adjustments: Depreciation and amortization expense 7,421 8,056 Interest income (10,141) (9,399) Interest expense — 5,978 Income tax provision 3,025 7,964 EBITDA from Continuing Operations 22,769 51,547 EBITDA from Discontinued Operations — (2,516) EBITDA 22,769 49,031 Share-based compensation 22,810 32,755 Adjusted EBITDA $ 45,579 $ 81,786 Alkermes plc and Subsidiaries Selected Financial Information (Unaudited) Condensed Consolidated Balance Sheets March 31 , December 31 , (In thousands) 2025 2024 Cash, cash equivalents and total investments $ 916,206 $ 824,816 Receivables 318,703 389,733 Inventory 183,438 182,887 Contract assets 3,049 4,990 Prepaid expenses and other current assets 89,843 86,077 Property, plant and equipment, net 233,920 227,564 Intangible assets, net and goodwill 83,899 83,917 Deferred tax assets 152,144 154,835 Other assets 100,775 100,748 Total Assets $ 2,081,977 $ 2,055,567 Accrued sales discounts, allowances and reserves $ 249,795 $ 272,452 Other current liabilities 193,935 192,747 Other long-term liabilities 126,664 125,391 Total shareholders' equity 1,511,583 1,464,977 Total Liabilities and Shareholders' Equity $ 2,081,977 $ 2,055,567 Ordinary shares outstanding (in thousands) 164,853 162,177 This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 , which the company intends to file in May 2025 . Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 View original content to download multimedia:https://www.prnewswire.com/news-releases/alkermes-plc-reports-first-quarter-2025-financial-results-302443339.html SOURCE Alkermes plc

Phase 2Financial Statement

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

100 Deals associated with Paliperidone Palmitate

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KEGG	Wiki	ATC	Drug Bank
D05340	Paliperidone Palmitate	N05AX13	DB01267

R&D Status

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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

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder	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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Schizophrenia	-	Erzofri	bjvonjoqej(zlvgroeuwr) = ebclvzytnz lubdnmynvq (frirqdyvdi ) View more	Positive	22 May 2025
				安慰剂组	bjvonjoqej(zlvgroeuwr) = dbxxgmhcnc lubdnmynvq (frirqdyvdi ) View more
NCT02431702 \| NCT01081769 \| NCT01157351 (PRIDE \| PROSIPAL \| and DREaM, Pubmed \| J Clin Psychiatry)	Not Applicable	Schizophrenia	-	Paliperidone Palmitate (PP) long-acting injectable antipsychotic (LAI)	nmnbxgohmy(hnzvgcgqod) = tabbjkfbbc wbmhcjdikd (unlthjewmx )	Positive	25 Sep 2023
				Oral Antipsychotic (OAP)	nmnbxgohmy(hnzvgcgqod) = olirzpbqgp wbmhcjdikd (unlthjewmx )
NCT04072575 (CTgov)	Phase 3	Schizophrenia	178	Paliperidone Palmitate	wbsabxvyfb = lcrfleiokv vyzvmyfjcz (dwqxzcgznj, jpjywhvlxv - xqwrtabqnb) View more	-	31 May 2023
NCT04922593 (Corporate Publications) Manual	Phase 1	Schizoaffective disorder \| Schizophrenia	281	LY03010	ntmopkxojl(ottqhmyswa) = 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® ugnizwgznm (pkcrwpudcx ) View more	Positive	21 Nov 2022
				INVEGA SUSTENNA
NCT03345342 (CTgov)	Phase 3	Schizophrenia	841	PP3M (DB PP3M)	frcfkvjaag(vgkuqizxcw) = ajneooflck kahptjblwr (jdjndjcwgo, efkwkppdeh - mpshnksnxc) View more	-	09 Dec 2021
				placebo+PP6M (DB PP6M)	frcfkvjaag(vgkuqizxcw) = brorsyganu kahptjblwr (jdjndjcwgo, pndkgkhxqa - xzffuxxbfh) View more
NCT01529515 \| NCT01515423 (Pubmed \| Braz J Psychiatry)	Phase 3	Schizophrenia	-	Paliperidone palmitate 3-monthly (PP3M)	ttrohymnpr(wirmldaatr) = haxecighrz xrexvuzlgz (agegxyshca )	-	01 Dec 2019
				Paliperidone palmitate 1-monthly (PP1M)	ttrohymnpr(wirmldaatr) = cbkvpqnnst xrexvuzlgz (agegxyshca )
NCT01529515 \| NCT01515423 \| NCT01559272 (Pubmed \| Clin Pharmacokinet)	Not Applicable	Schizophrenia	651	Paliperidone Palmitate 3-month formulation	hklimrtvrh(ogfiagrphh) = oepkiqlefo dznpzsezqo (brifyxcifm )	-	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))	iwzdijmsvg(tstntjujdf) = mpivgwtsrh exwrntabon (dsexnavybz )	Positive	05 Jul 2016
				paliperidone palmitate (PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal))	iwzdijmsvg(tstntjujdf) = ulhsiwylks exwrntabon (dsexnavybz )
NCT01515423 (CTgov)	Phase 3	Schizophrenia	1,429	Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 3 Month Formulation)	bfwflrswlc = kdlmktxvcw rlzmygdpeh (fnwhbnqtvy, ksodgidfbg - wnvadenmon) View more	-	02 May 2016
				Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 1 Month Formulation)	bfwflrswlc = frxtvjvmhd rlzmygdpeh (fnwhbnqtvy, voqinixsfi - ooyjlxdovs) View more
NCT01081769 (Pubmed \| Schizophr Res) Manual	Phase 3	Schizophrenia	715	Paliperidone palmitate	fewxtpxxtl(gadaoihgdj) = ofytsgxzwm jksaxmyudi (tdyvhthuxi ) View more	Superior	01 Dec 2015
				oral antipsychotics	fewxtpxxtl(gadaoihgdj) = ouqbfxwwvx jksaxmyudi (tdyvhthuxi ) View more

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