Paliperidone Palmitate

新“马甲”，很神奇 同一种药，换个“马甲”就能更有效、更长效、副作用更小，真有这么神奇吗？创新给药剂型让这件事成真。药物新剂型是在传统药物剂型基础上，通过创新技术或方法研发出的新型药物形态。制成新剂型，好比穿上不同的“马甲”，实现长效、靶向以及副作用最小化，提高药物临床依从性。 从长效缓释制剂微球、微晶到“精准投放”的靶向制剂脂质体、纳米粒，从薄如糯米纸的口溶膜到快速起效的软胶囊，近年来，齐鲁制药构建起多个高端复杂制剂技术平台，突破“卡脖子”关键技术，解决未满足的临床需求，不断惠及广大患者。 一天三次变一月一针 在齐鲁制药布局的新剂型产品里，微球的技术难度最大，也是最具价值的制剂之一。微球制剂是由包裹着药物、粒径为1到250微米的球状实体组成，大多数上市的微球产品的粒径从十几微米到几十微米不等。微球到底有多“微”？1微米只有头发丝的1/50。 微球肉眼看起来就是一堆粉末，本领却大得不得了，精确控制药物的释放速率，可持续平稳释放药物几周至数月，最长可实现6个月给药一次，不用老跑医院打针，大大提高患者的用药依从性，并减轻用药经济负担。2023年8月，齐鲁制药注射用醋酸奥曲肽微球获得国家药监局批准上市，为该产品国内首家获批，同时，也是国内首个按照仿制药一致性评价要求批准上市的长效微球制剂。奥曲肽微球一个月只需给药一次，相比于每日注射三次的普通剂型，它显著降低了注射频率和不良反应。 微晶/纳米晶制剂是将原料药粉碎或研磨成微米晶体（粒径1-100微米）或纳米晶体（粒径100-1000纳米）并悬浮于水溶液或油溶液中，也能持续、缓慢释放药物，用药一次能管1个月甚至6个月，口服、注射、透皮、眼部给药统统涵盖。 2023年10月，齐鲁制药长效微晶制剂棕榈酸帕利哌酮注射液获得国家药监局批准上市，为国内首家，同时，也是首个批准上市的国产月度给药长效微晶制剂。该产品每月仅需给药1次，兼具急性期快速起效，维持期持续改善症状的作用。此外，棕榈酸帕利哌酮注射液获美国FDA临时性批准。 精准靶向出击，副作用更小 复杂制剂军团中除了超长待机的“长效缓释战士”，还有专攻病灶的“特种兵”，脂质体、纳米粒等纳米制剂就是典型代表。纳米制剂靶向出击，能让药物精准到达病灶，提高药物有效浓度，疗效更佳，降低药物全身毒性和不良反应。 脂质体是用脂质分子包封住药物，形成一个微型胶囊，就像一个“泡泡”，把药物精准投放到身体需要的地方。脂质体制剂能加强药物利用度和稳定性，同时降低对正常组织的损害，降低毒性，减少不良反应。2024年5月，齐鲁制药盐酸多柔比星脂质体注射液获批上市，因其强大的抗肿瘤活性、较同类抗肿瘤抗生素高出数倍的成药性，广泛用于乳腺癌、卵巢癌、多发性骨髓瘤等肿瘤治疗。此外，另一款脂质体药物两性霉素B脂质体已在中国、美国和欧洲申报上市。 纳米粒制剂是以纳米级颗粒（10-100纳米）为载体，包裹着药物，保护药物不被分解或失活。纳米粒能精准锁定肿瘤组织，到达病灶部位后药物分子缓慢释放，既提高打击精度，又减少对健康细胞的伤害，提升患者生活质量。2019年，齐鲁制药纳米粒制剂注射用紫杉醇（白蛋白结合型）获批上市，白蛋白作为载体，利用纳米技术把白蛋白与不溶于水的紫杉醇结合，相较于传统溶剂，避免了多种不良反应。与传统紫杉醇制剂相比，纳米粒剂型高疗效，低毒性，使用方便。 软雾吸入剂则是通过局部给药实现“靶向”，高效递送的软雾剂装置让药液雾化，形成细腻、缓慢移动的药雾，直接递送到肺部，相比于传统气雾剂，到达肺部的药物剂量高得多。软雾剂实现快速起效与精准治疗的双重优势，而且全身不良反应少。今年齐鲁制药两个软雾剂产品噻托溴铵奥达特罗吸入喷雾剂和噻托溴铵吸入喷雾剂国内申报上市，主要用于慢性阻塞性肺疾病（包括慢性支气管炎和肺气肿）的长期维持治疗。 让吃药难变为吃药易 一个生病的孩子哭闹着不肯吃药，一个哮喘患者半天不会用干粉吸入剂，一个精神病患者把药吐出来……很多时候，用药难成为治疗“拦路虎”，而剂型的改进和给药方式创新轻松化解难题。 软雾剂的一大优势就是便携易用，相比要精确配合吸气和按压的传统吸入剂，患者可自然吸气，无需吸气配合，操作简单，难度低，对儿童、老年人和肺功能降低或呼吸困难的患者非常友好。 口溶膜则让吃药变得像“吃糖”般轻松，口溶膜是含药聚合物薄膜，看起来像一张小小糯米纸，入口是水果味，不用水送服，在口中十几秒溶解。而且口溶膜易吸收、起效快、副作用小，尤其适用于儿童、老年、吞咽困难的患者，大大提高用药依从性。 2013年，齐鲁制药开始布局口溶膜制剂研发，是国内最早进行此类改良型剂型研究的药企。2021年，公司首个口溶膜产品奥氮平口溶膜获批上市，为精神疾病患者提供全新、更便捷的用药选择。今年7月，又有一款抗精神病药物利培酮口溶膜获批上市。目前齐鲁制药已有6个口溶膜产品上市，5个为国内首家，包括适用于儿童哮喘的孟鲁司特钠口溶膜、适用于阿尔茨海默症的盐酸美金刚口溶膜等。 软胶囊也是一款让吃药变得更容易的新剂型，把液状油性物完全气密封装于软质囊材中，能掩盖药物不良气味、方便服药。服用后软胶囊能够在胃部迅速溶解，释放出药物，从而有利于药物的快速吸收。齐鲁制药已上市乙磺酸尼达尼布软胶囊、二十碳五烯酸乙酯软胶囊等7个软胶囊产品，覆盖心血管、呼吸、泌尿、免疫系统等多个治疗领域。 “高精尖”复杂制剂不断“上新” 如今，高技术壁垒的复杂注射剂研发已成为药物创新的热点，其临床价值明显、安全性好等特点为临床需求提供“更优解”。早在2007年，齐鲁制药就开始创新布局，搭建多个高端复杂制剂技术平台，开发高技术壁垒复杂制剂和新型给药技术药物，不断突破技术壁垒，实现多款首仿药和改良型创新药快速上市，用更多新药、好药。 目前，齐鲁制药已有微球、微晶、纳米粒、脂质体、口溶膜、软胶囊、亚微乳、渗透泵控释片等30多项复杂制剂产品获批上市，其中10余项为国内首家或独家获批上市，为临床医生和患者提供更贴合个体需求、具有临床实用性的用药新选择。 点击下方关键词 获取更多资讯  ↓↓ | 李燕总裁 | 全国人大代表 |  | 中国医药百强 | 伊鲁阿克 | 患者招募 |  | 雷珠单抗 | 全球首创艾托组合抗体 | 曲帕双靶组合 |  | 董事长的二十万个蛋糕 | 社会责任企业 |

21 abstracts from across the Company's portfolio highlight clinical and real-world data on major depressive disorder, treatment-resistant depression and schizophrenia New Phase 3 data demonstrate the safety and efficacy of adjunctive seltorexant compared to quetiapine XR in major depressive disorder with insomnia symptoms TITUSVILLE, N.J., Sept. 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 21 abstracts featuring new real-world and clinical trial data will be presented at the annual U.S. Psychiatric and Mental Health Congress (Psych Congress), taking place September 17 to 21 in San Diego, California. Presentations include the latest research from across the Company's neuropsychiatry portfolio, including major depressive disorder (MDD), treatment-resistant depression (TRD) and schizophrenia. "As the global leader in neuropsychiatry, we're harnessing decades of knowledge and expertise to redefine what's possible for people living with neuropsychiatric disorders," said Bill Martin, Ph.D., Global Neuroscience Therapeutic Area Head, Johnson & Johnson Innovative Medicine. "With patients at the center of everything we do, we are excited to present new clinical and real-world data from our leading portfolio, showcasing our commitment to advancing science and research to transform care and improve outcomes throughout the patient journey." Key presentations include: New data from a Phase 3 head-to-head study evaluating the safety and efficacy of seltorexant, an investigational first-in-class therapy, in combination with an oral antidepressant compared to adjunctive quetiapine extended release (XR) in MDD with insomnia symptoms (Poster 25).1 Results from a post-hoc analysis of a Phase 3 study evaluating the efficacy of adjunctive CAPLYTA® in MDD patients who also met DSM-5 criteria for anxious distress (Poster 15).2 Data from post-hoc analyses evaluating the effect of SPRAVATO® as a monotherapy on anhedonia symptoms and emotional blunting in adults with TRD (Posters 21,46).3,4 "A staggering one in eight people worldwide are living with a mental health disorder," said Tyrone Brewer, President, U.S. Neuroscience, Johnson & Johnson Innovative Medicine.5 "At Johnson & Johnson, we are unwavering in our commitment to deliver a portfolio of differentiated and impactful solutions that confront neuroscience's toughest challenges. We remain steadfast in our pursuit of breakthroughs for patients who need them most." J&J will present the following posters at Psych Congress on September 19 at 12:00 – 3:00 p.m. PT and September 20 at 12:00 – 3:00 p.m. PT in the Exhibit Hall. ABOUT MAJOR DEPRESSIVE DISORDER (MDD) MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people– or about 5 percent of the population.5,6 In 2021, approximately 21 million adults in the U.S. had at least one major depressive episode.7 While depression is typically treated with a "one-size-fits-all" approach, no two cases are the same. MDD is a complex, heterogeneous disorder involving multiple regions of the brain and presenting with as many as 256 unique symptom combinations.8,9 As a result, responses to treatment vary widely. With current standard-of-care oral antidepressants, 2 in 3 people living with MDD continue to experience residual or persistent symptoms.10 Moreover, MDD is a risk factor for the development and worsening of a range of comorbidities, illustrating the importance of integrating mental and general health care.11 MDD is often accompanied by sleep disturbances such as insomnia or hypersomnia, with approximately 60 percent of MDD patients experiencing insomnia symptoms despite being on standard-of-care oral antidepressants.12 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.13,14 Approximately one-third of adults with MDD will not respond to oral antidepressants alone and are considered to have treatment-resistant depression (TRD), which is often defined as inadequate response to two or more oral antidepressants that were administered at an adequate dose for an adequate duration.7,15 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.15 Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief.16 Based on the STAR*d study after trying their third oral antidepressant, approximately 86 percent of patients do not achieve remission.16 ABOUT CAPLYTA® (lumateperone) CAPLYTA® is approved by the U.S. FDA for the treatment of adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While its exact mechanism of action is unknown, CAPLYTA® is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. A supplemental new drug application (sNDA) for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder is currently under U.S. Food and Drug Administration review. ABOUT SELTOREXANT Seltorexant, an investigational 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 selectively antagonizes the orexin-2 receptors, potentially improving mood symptoms and restoring sleep without next-day sedation in patients with depression.17 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.18,19 Seltorexant is the only investigational therapy being studied in MDD that is believed to work by normalizing the overactivation of the orexin-2 receptors, thereby addressing the underlying biology that contributes to depression and causes insomnia symptoms. ABOUT SPRAVATO® SPRAVATO® (esketamine) CIII nasal spray is approved by the U.S. Food and Drug Administration alone or in conjunction with an oral antidepressant for adults with MDD when they have inadequate response to at least two oral antidepressants (TRD) and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. It is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than traditional antidepressants by acting on a pathway in the brain that affects glutamate. The mechanism by which esketamine exerts its antidepressant effect is unknown. To date, SPRAVATO® has been approved in 79 markets and administered to more than 150,000 patients worldwide. ABOUT SCHIZOPHRENIA Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the U.S. yet remains widely misunderstood and insufficiently treated.20 Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common.21 Evidence shows that the first three to five years after diagnosis – "the critical period" – from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly.22,23 A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with schizophrenia.24 ABOUT J&J'S SCHIZOPHRENIA PORTFOLIO Johnson & Johnson's portfolio of schizophrenia therapies offers the broadest range of oral and long-acting injectable treatment options to support each patient's individual treatment journey. The Company's 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, including 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.21,22 CAPLYTA® is a once-daily oral therapy approved to treat adults with schizophrenia. A supplemental New Drug Application (sNDA) for CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia was recently submitted to the U.S. Food and Drug Administration. CAPLYTA® Important Safety Information CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above. Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued. Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors. Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension. Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA. Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold. Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them. Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics. Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration. Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors. Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warnings. SPRAVATO® IMPORTANT SAFETY INFORMATION What is SPRAVATO® (esketamine) CIII nasal spray? SPRAVATO® is a prescription medicine used: with or without an antidepressant taken by mouth, to treat adults with treatment-resistant depression (TRD) with an antidepressant taken by mouth, to treat 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 What is the most important information I should know about SPRAVATO®? SPRAVATO® can cause serious side effects, including: Sedation, dissociation, and respiratory depression. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), breathing problems (respiratory depression and respiratory arrest) Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out. Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting. Abuse and misuse. There is a risk for abuse and misuse with SPRAVATO®, which may lead to physical and psychological dependence. Your healthcare provider should check you for signs of abuse, misuse, and dependence before and during treatment. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction. SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (such as medical offices and clinics) must be enrolled in the program. Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO® is not for use in children. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Tell your healthcare provider or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: 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 unborn 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  programs/pregnancyregistry/antidepressants/. are breastfeeding or plan to breastfeed. SPRAVATO® passes into your breast milk. 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) medicines. 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 ® 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 Johnson & Johnson at 1-800-526-7736, or to the 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-170363v4 INVEGA SUSTENNA®, INVEGA TRINZA®, INVEGA HAFYERA® 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. INVEGA SUSTENNA®, INVEGA TRINZA®, INVEGA HAFYERA® IMPORTANT SAFETY INFORMATION What is the most important information I should know about INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA®? INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® are not for the treatment of people with dementia-related psychosis. 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 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 @JNJInnovMed. © Johnson & Johnson and its affiliates 2025. All rights reserved. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to CAPLYTA®, Seltorexant, SPRAVATO®, INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA®. 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 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 healthcare products and services; changes to applicable laws and regulations, including global healthcare reforms; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties, and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, 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 U.S. Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. References: Flossbach Y, Mesens S, Pandina G et al. Seltorexant Versus Quetiapine Extended Release as Adjunctive Treatment in Major Depressive Disorder With Insomnia Symptoms: Phase 3 Trial. Psych Congress 2025; September 17-21, 2025. Poster 25. Durgam S, Earley W.R., Kozauer, S.G. et al. Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder and Anxious Distress. Psych Congress 2025; September 17-21, 2025. Poster 15. Himedan M, Fu D-J, Lopena O, et al. Montgomery-Åsberg Depression Rating Scale Anhedonia Factor Score Following Esketamine Nasal Spray Monotherapy in Adult Patients With Treatment-Resistant Depression: A Post Hoc Analysis. Psych Congress 2025; September 17-21, 2025. Poster 21. Fu D-J, Turkoz I, Cabrera P, et al. Effect of Esketamine Nasal Spray Monotherapy on Emotional Blunting in Adult Patients With Treatment-Resistant Depression: A Post Hoc Analysis. Psych Congress 2025; September 17-21, 2025. Poster 46. World Health Organization. Mental disorders. Accessed April 2025. National Alliance on Mental Health. Mental health by the numbers. Accessed May 2025. National Institute of Mental Health. Major Depression. Accessed May 2025. Su YA and Si T. Progress and challenges in research of the mechanisms of anhedonia in major depressive disorder. Gen Psychiatr. 2022;35:e100724. doi: 10.1136/gpsych-2021-10072 Pandya M, et al. Where in the Brain Is Depression? Curr Psychiatry Rep. 2012;14:634–642. doi: 10.1007/s11920-012-0322-7 Israel, J. A. (2010, August 3). The impact of residual symptoms in major depression. Pharmaceuticals (Basel, Switzerland). Arnaud AM, Brister TS, Duckworth K, et al. Impact of major depressive disorder on comorbidities: a systematic literature review. J Clin Psychiatry. 2022;83(6):21r14328. Ohayon MM, Roth T. Place of chronic insomnia in the course of depressive and anxiety disorders. J Psychiatr Res. 2003;37(1):9-15. doi:10.1016/S0022-3956(02)00052-3 Taddei-Allen P. Economic Burden and Managed Care Considerations for the Treatment of Insomnia. AJMC. Updated April 12, 2020. Accessed June 27, 2024. Ağargün MY, Kara H, Solmaz M. Sleep disturbances and suicidal behavior in patients with major depression. J Clin Psychiatry. 1997;58(6):249-51. 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. doi: 10.4088/JCP.20m13699 Sanacora G, Zarate C, Krystal J, et al. Targeting the glutamatergic system to develop novel, improved therapeutics for mood disorders. Nat Rev Drug Discov. 2008;7(5):426-437. doi:10.1038/nrd2462 Recourt K, de Boer P, Zuiker R, et al. The selective orexin-2 antagonist seltorexant (JNJ-42847922/MIN-202) shows antidepressant and sleep-promoting effects in patients with major depressive disorder [published correction appears in Transl Psychiatry. 2019 Oct 2;9(1):240. doi: 10.1038/s41398-019-0585-4]. Transl Psychiatry. 2019;9(1):216. Published 2019 Sep 3. doi:10.1038/s41398-019-0553-z Nollet M, Leman S. Role of orexin in the pathophysiology of depression: potential for pharmacological intervention. CNS Drugs. 2013;27(6):411-422. doi:10.1007/s40263-013-0064-z Brooks S, Jacobs GE, de Boer P, et al. The selective orexin-2 receptor antagonist seltorexant improves sleep: An exploratory double-blind, placebo controlled, crossover study in antidepressant-treated major depressive disorder patients with persistent insomnia. J Psychopharmacol. 2019;33(2):202-209. doi:10.1177/0269881118822258 Treatment Advocacy Center. Schizophrenia Fact Sheet. Accessed June 2025. . Tandon, Rajiv et al. "The schizophrenia syndrome, circa 2024: What we know and how that informs its nature." Schizophrenia research vol. 264 (2024): 1-28. doi:10.1016/j.schres.2023.11.015 Birchwood, M. "Early intervention and sustaining the management of vulnerability." The Australian and New Zealand Journal of Psychiatry. vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241 National Alliance on Mental Illness. Understanding Schizophrenia. Accessed June 2025. Understanding Schizophrenia | NAMI: National Alliance on Mental Illness. Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy. Int Clin Psychopharmacol. 2016;31(4)202-209. doi:10.1097/YIC.0000000000000125 © Johnson & Johnson 2025. 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