Hyperprolactinemia

Analysis of real-world data compared patients on GIMOTI (n=51) to Oral Metoclopramide (n=41), both taking GLP-1s, showing significant statistical improvement for GIMOTI over Oral Metoclopramide in All Cause Emergency Department Visits (-91%, p=0.001), All Cause Office Visits (-41%, p=0.027) and All Cause Hospital Outpatient Visits (-89%, p=0.032) within 6-month index period Data presented at American College of Gastroenterology (ACG) 2024; the submission garnered both the Presidential Poster Award as one of the top 5% of data accepted to the conference and selected as the Outstanding Research Award in the Stomach Category First study to show Gimoti’s potential as supportive care for GLP-1 therapy SOLANA BEACH, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on developing treatments for gastrointestinal (GI) diseases, with a particular emphasis on GIMOTI® (metoclopramide) nasal spray, together with EVERSANA, a leading provider of global commercial services to the life sciences industry, today announced the presentation of data for GLP-1 users with diabetic gastroparesis using GIMOTI at the American College of Gastroenterology (ACG) 2024 Annual Meeting. The real-world retrospective study evaluated the impact of GIMOTI (metoclopramide nasal spray) in patients with diabetic gastroparesis (DGP) who were concurrently using GLP-1 receptor agonists. GLP-1 drugs are commonly prescribed for type 2 diabetes, and with the approval of GLP-1 medications, there have been increasing reports of these drugs exacerbating GI symptoms, specifically gastroparesis. GLP-1 medications function, in part, by causing delayed gastric emptying. Delayed gastric emptying, in the absence of mechanical obstruction, is the definition of gastroparesis. In a recent National Institute of Health (NIH) study (https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/38399414/), an estimated 5.1% of patients in their study (n=10,328) on GLP-1 medications had gastroparesis. The GIMOTI study compared healthcare resource utilization (HRU) between patients using GIMOTI nasal metoclopramide (NMCP) and those on oral metoclopramide (OMCP), specifically focusing on individuals with a prior GLP-1 prescription. Significant reductions across a collection of outcomes were observed in patients treated with GIMOTI versus oral metoclopramide. Key Study Findings Presented at ACG 2024: Patients with prior GLP-1 history had reduced HRU after taking NMCP In NMCP patients, all-cause emergency department (ED) visits decreased by 55% (mean [SD]: 0.25 [1.13] post-index vs. 0.55 [1.30] pre-index; p=0.063); andDGP-related ED visits decreased by 28% (mean [SD]: 0.18 [0.99] post-index vs. 0.25 [1.28] pre-index; p=0.203). In patients taking GLP-1, those that took NMCP had fewer healthcare visits compared to those taking OMCP All-cause and DGP-related ED visits were 91% lower (cIRR: 0.09, 95% CI: 0.01, 0.42; p=0.001) and 89% lower (cIRR: 0.11, 95% CI: 0, 0.93; p=0.046) for NMCP vs. OMCP; andAll-cause Hospital Outpatient visits were 89% lower (cIRR = 0.11, 95% CI: 0.01, 0.73; p = 0.032)All-cause and DGP-related office visits were 41% lower (cIRR: 0.59, 95% CI: 0.37, 0.94; p=0.027) and 66% lower (cIRR: 0.34, 95% CI: 0.017, 0.65; p=0.001) for NMCP vs. OMCP. NMCP can be used to effectively treat patients with gastroparesis taking GLP-1 treatment and avoid costly healthcare visits All-cause clinic, outpatient, and inpatient visits showed similar trends favoring NMCP vs. OMCP.In DGP patients with a prior claim for GLP-1, NMCP use was associated with numerically and significantly reduced all-cause and DGP-related HRU compared to pre-treatment utilization and OMCP-treated controls. "This data is particularly encouraging given the rising number of patients using GLP-1 agonists for diabetes, many of whom also suffer from gastroparesis," said Matt D’Onofrio, CEO of Evoke Pharma. "Our goal is to provide data regarding Gimoti as supportive care for diabetic gastroparesis for those also on GLP-1 agonists. This study, combined with the earlier real-world data presented at key conferences, reinforces GIMOTI's potential to improve outcomes for patients and reduce the overall financial burden on the healthcare system." The study's specific cohort consisted of 92 total patients between the nasal metoclopramide (NMCP, N=51) and oral metoclopramide (OMCP, N=41) groups. The NMCP group had a slightly older average age (55.1 years) compared to the OMCP group (53.1 years). A notable portion of the NMCP group (31.4%) had experienced hospitalizations or emergency department visits before treatment, compared to 19.5% in the OMCP group. In a separate study, a post-hoc analysis focused on safety data for a female subgroup from a previous Phase 3 study that included 36 women using GLP-1 drugs during the 28-day study. Among these, 13 were treated with GIMOTI and 23 with placebo. The majority (94%) of the participants completed the study, with no serious adverse events reported in either group. This analysis indicated no series safety issues and a trend toward nausea improvement when GLP-1 drugs were used with NMCP. "Our continued focus is helping patients that have gastroparesis and diabetes. The fact that up to 20 million patients (KFF Health Tracking Poll (April 23-May 1, 2024) (kff.org/KFF Health Tracking Poll)) may have taken or are currently taking GLP-1s for their diabetes, indicates this is an important patient constituency the medical community needs to monitor and address," said Chris Quesenberry, Chief Commercial Officer of Gimoti. "Evoke Pharma, through its clinical development program and real-world evidence studies, is uniquely positioned to provide clinicians with information that may inform treatment decisions. This study provides insight that clinicians who treated their patients with diabetic gastroparesis, who were also taking a GLP-1, benefitted in taking GIMOTI®, an innovative, non-oral therapy that does not rely on a dysfunctional gut to work." The results presented at ACG 2024 build on a growing body of real-world data that underscores GIMOTI's ability to significantly reduce HRU in patients with diabetic gastroparesis. Earlier studies presented at Digestive Disease Week (DDW) 2024 and ACG 2023 demonstrated that patients treated with GIMOTI showed fewer hospitalizations, emergency department visits, and physician office visits compared to those using oral metoclopramide. Also, these studies highlighted that GIMOTI reduced healthcare costs by over $15,000 per patient in a six-month period compared to oral metoclopramide​​. "These studies further confirm the important role of GIMOTI in managing diabetic gastroparesis and supports its use for patients concurrently on GLP-1 agonists," said Dr. Michael Cline, Medical Director of the Gastroparesis Clinic at Cleveland Clinic, an author of the study. "In my practice, I’ve treated patients arriving with gastroparesis while on a GLP-1. This data demonstrates a significant reduction in emergency room visits, office visits, and overall healthcare resource utilization, which not only improves patient outcomes but also reduces the strain on healthcare systems. The nasal delivery of metoclopramide offers a distinct advantage for patients with delayed gastric emptying, ensuring they receive the relief they need without the complications or unknown absorption associated with oral medications." EVERSANA was named Evoke’s commercialization partner to support commercialization efforts of GIMOTI, first in 2020 and then an extended partnership was announced in February 2022. Slides referencing data to the studies can be found under news and presentations of the Evoke Pharma investor relations website. About Evoke Pharma, Inc. Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information. Follow Evoke Pharma on LinkedInFollow Evoke Pharma on Twitter About Gimoti® (metoclopramide) nasal spray GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information: WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use. GIMOTI is not recommended for use in: Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. GIMOTI is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm. Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Safe Harbor Statement Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: GIMOTI’s potential to reduce HRU by diabetic gastroparesis patents taking GLP-1 therapies; the possibility that increased use of GLP-1 agonists could increase the need for treatment of gastroparesis or increase the patient base for GIMOTI; and Evoke’s belief that GIMOTI can improve treatment of gastroparesis in patients taking GLP-1 agonists. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke and EVERSANA may not be able to successfully drive market demand for GIMOTI; the results of market research studies may not predict acceptance by patients, healthcare providers or payors; GLP-1 agonists may not increase the number of patients diagnosed with gastroparesis, which remains speculative; alternative treatments for gastroparesis may be developed or approved and may be shown to be superior to GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; Evoke’s ability to maintain compliance with Nasdaq’s stockholder’s equity requirements; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. About EVERSANA EVERSANA® is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X. Investor & Media Contact: Daniel Kontoh-Boateng DKB Partners Tel: 862-213-1398 dboateng@dkbpartners.net A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cfc46127-a976-498b-8e19-d5c879171b81

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

PRINCETON, N.J., July 28, 2024 /PRNewswire/ -- Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's ERZOFRI® (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurring relapses[1]. Antipsychotic medications play an important role in treating and controlling symptoms of schizophrenia and schizoaffective disorder, but patient adherence to antipsychotics is generally poor. Using long-acting injectable (LAI) antipsychotics is effective in improving patient adherence, as they can reduce the dosing frequency and can also reduce the risk of patients not adhering to their dosing regimen without the knowledge of their healthcare providers[2]. ERZOFRI, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S. The product was granted a U.S. patent (Patent No.11,666,573) in 2023, which will expire in 2039. ERZOFRI is approved as a new drug under the 505(b) (2) pathway in the U.S. According to publicly available information, the sales of paliperidone palmitate LAIs were $2.897 billion across the U.S. in 2023[3]. ERZOFRI will provide patients with a new treatment option after its launch. ABOUT ERZOFRI® What is ERZOFRI (paliperidone palmitate) extended-release injectable suspension? ERZOFRI is an atypical antipsychotic indicated for: The treatment of schizophrenia in adults. The treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. IMPORTANT SAFETY INFORMATION FOR ERZOFRI WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ERZOFRI is not approved for use in patients with dementia-related psychosis. CONTRAINDICATIONS: ERZOFRI is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the ERZOFRI formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions: In clinical trials in elderly patients with dementia-related psychosis, increased risk of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities, have been reported in patients taking atypical antipsychotic medications compared to placebo. ERZOFRI is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported in association with antipsychotic drugs. Manage with immediate discontinuation and close monitoring. QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. The use of paliperidone should be avoided in combination with other drugs that are known to prolong QTc. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome. Whether antipsychotic drug products differ in their potential to cause TD is unknown. The risk of developing TD and the likelihood that it will become irreversible appear to increase with the duration of treatment and the cumulative dose. The syndrome can develop after relatively brief treatment periods, even at low doses. It may also occur after discontinuation of treatment. TD may remit, partially or completely, if antipsychotic treatment is discontinued. Antipsychotic treatment itself may suppress (or partially suppress) the signs and symptoms of the syndrome and may thus mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. If signs and symptoms of TD appear in a patient treated with ERZOFRI, drug discontinuation should be considered. However, some patients may require treatment with ERZOFRI despite the presence of the syndrome. Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes, including hyperglycemia, dyslipidemia, and body weight gain. Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with all atypical antipsychotics. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening glucose control. Patients with risk factors for diabetes mellitus who are starting treatment with atypical antipsychotics, including ERZOFRI, should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug. Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitoring weight is recommended. Orthostatic Hypotension and Syncope: Paliperidone can induce orthostatic hypotension and syncope in some patients. Use ERZOFRI with caution in patients with known cardiovascular disease (e.g., heart failure, history of myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension. Monitoring of orthostatic vital signs should be considered in patients who are vulnerable to hypotension. Falls: Somnolence, postural hypotension, motor and sensory instability have been reported with the use of antipsychotics, including paliperidone palmitate, which may lead to falls and, consequently, fractures or other fall-related injuries. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy. Leukopenia, Neutropenia, and Agranulocytosis: Events of leukopenia, neutropenia, and agranulocytosis have been reported temporally related to antipsychotic agents. Patients with a history of a clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC) or past drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy. Discontinuation of ERZOFRI should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue ERZOFRI in patients with absolute neutrophil count <1000/mm3 and follow their WBC until recovery. Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, paliperidone elevates prolactin levels and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to that seen with risperidone, a drug that is associated with higher levels of prolactin than other antipsychotic drugs. Long-standing hyperprolactinemia, when associated with hypogonadism, can lead to decreased bone density in males and females. Potential for Cognitive and Motor Impairment: Antipsychotics, including ERZOFRI, have the potential to impair judgement, thinking, and motor skills. Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that paliperidone therapy does not adversely affect them. Seizures: ERZOFRI should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Antipsychotic drugs, including ERZOFRI, should be used cautiously in patients at risk for aspiration. Priapism: Priapism has been reported with oral paliperidone during postmarketing surveillance. Severe priapism may require surgical intervention. Disruption of Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing ERZOFRI to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, such as exercising strenuously, exposure to extreme heat, receiving anticholinergic medications, or dehydration. ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 5% and occurring at least twice as often as placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder. DRUG INTERACTIONS An additive effect may occur when co-administered ERZOFRI with drugs that may cause orthostatic hypotension. Avoid using a strong inducer of CYP3A4 and/or P-glycoprotein (P-gp) during a dosing interval for ERZOFRI. If concomitant use is necessary, consider using paliperidone extended-release tablets. USE IN SPECIFIC POPULATIONS Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including ERZOFRI, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at . Lactation: Infants exposed to ERZOFRI through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements). Fertility: Based on the pharmacologic action of paliperidone (D2 receptor antagonism), treatment with ERZOFRI may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential. Pediatric Use: Safety and effectiveness of ERZOFRI in pediatric patients have not been established. Please see full Prescribing Information at , including BOXED WARNING, for ERZOFRI. About the Clinical Trial The U.S. FDA approval of ERZOFRI is based on the results of an open-label, randomized, multiple-dose, parallel-group study that enrolled 281 patients (ages 18-65) with schizophrenia or schizoaffective disorder (NCT04922593), designed to evaluate the PK profile of ERZOFRI and its relative bioavailability compared with the listed drug INVEGA SUSTENNA®. ERZOFRI was demonstrated to be bioequivalent to the listed drug at steady state after multiple injections. Compared with the listed drug, the initial dosing was optimized for ERZOFRI by omitting the injection on Day 8 after the first injection, resulting in a comparable total drug exposure. The safety profile of ERZOFRI was consistent with the known safety profile of the listed drug. 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 30 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