PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) today presented results from the Phase II (Trial 061) and Phase III trials (Trial 071 and 072) evaluating the safety and efficacy of brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).1,2 The findings were presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami..

新泽西州普林斯顿和伊利诺伊州迪尔菲尔德（BUSINESS WIRE）--大冢制药开发与商业化公司（Otsuka）和伦贝克制药有限责任公司（Lundbeck）今天介绍了第二阶段（试验061）和第三阶段试验（试验071和072）的结果，评估了brexpiprazole联合舍曲林治疗成人创伤后应激障碍（PTSD）的安全性和有效性。1,2研究结果在迈阿密举行的美国临床心理药理学学会（ASCP）年会上发表。。

The primary endpoint for all three trials was the change from Week 1 to Week 10 in the CAPS-5 total score for brexpiprazole and sertraline combination therapy versus sertraline plus placebo in patients diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).1.

所有三项试验的主要终点是根据《精神障碍诊断和统计手册》第五版（DSM-5），在诊断为PTSD的患者中，brexpiprazole和舍曲林联合治疗与舍曲林加安慰剂的CAPS-5总分从第1周到第10周的变化。

The trials were randomized, double blind, active-controlled, and Trial 061 and 071 were flexible dose trials, while Trial 072 was a fixed dose trial.1 In Trial 061 and 071, brexpiprazole in combination with sertraline was associated with a statistically significant reduction (p<0.05) in PTSD symptoms compared to sertraline plus placebo, as measured by the change in the Clinician-Administered PTSD Scale (CAPS-5) total score from baseline to Week 10 (primary endpoint).

这些试验是随机、双盲、主动对照的，试验061和071是灵活剂量试验，而试验072是固定剂量试验。在试验061和071中，布雷哌唑联合舍曲林与舍曲林联合安慰剂相比，PTSD症状的统计学显着降低（p<0.05），这是通过临床医生管理的PTSD量表（CAPS-5）总分从基线到第10周（主要终点）的变化来衡量的。

In Trial 072, while the primary endpoint was not met, reductions in PTSD symptom severity with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071. Improvements were consistently observed across the Clinical Global Impression Severity (CGI-S) scale and the four CAPS-5 clusters of re-experiencing, avoidance, negative cognition/mood and arousal/reactivity symptoms in Trials 061 and 071.1,4.

在试验072中，虽然未达到主要终点，但brexpiprazole联合舍曲林降低PTSD症状严重程度与试验061和071一致。在试验061和071.1,4中，在临床总体印象严重程度（CGI-S）量表和四个CAPS-5集群的再次体验，回避，负面认知/情绪和唤醒/反应症状中始终观察到改善。

“Only approximately half of people living with PTSD seek treatment, even though it is one of the most common mental health conditions in the United States,” said Lori Davis, M.D., clinical professor of psychiatry in the Department of Psychiatry and Behavioral Neurobiology, University of Alabama School of Medicine.

阿拉巴马大学医学院精神病学和行为神经生物学系精神病学临床教授Lori Davis医学博士说：“尽管创伤后应激障碍是美国最常见的心理健康状况之一，但只有大约一半的创伤后应激障碍患者寻求治疗。”。

“For the first time, we now have data from a comprehensive clinical trial program that show a combination of medicines can help improve the four symptom clusters of PTSD as defined by the DSM-5.”.

“我们现在首次从一项综合临床试验计划中获得数据，表明联合用药可以帮助改善DSM-5定义的创伤后应激障碍的四种症状群。”。

Across the three randomized trials, the combination of brexpiprazole and sertraline in adult patients with PTSD were generally well-tolerated, and no new safety observations were identified. The safety and tolerability results were consistent with the known profile of brexpiprazole in its approved indications and what has been observed in other clinical trials.

在三项随机试验中，brexpiprazole和舍曲林联合治疗成年创伤后应激障碍患者的耐受性通常良好，没有发现新的安全性观察结果。安全性和耐受性结果与brexpiprazole在其批准的适应症中的已知特征以及在其他临床试验中观察到的一致。

The overall incidence of treatment-emergent adverse events (TEAEs) across the three trials was 55.5 percent with brexpiprazole plus sertraline, and 56.2 percent with sertraline plus placebo.2.

三项试验中治疗紧急不良事件（TEAE）的总发生率为布雷哌唑加舍曲林为55.5%，舍曲林加安慰剂为56.2%。

In Trial 061, the least squares mean change from randomization (Week 1) in CAPS-5 total score was -16.4 with brexpiprazole in combination with sertraline (p=0.011 versus sertraline plus placebo), -12.2 with brexpiprazole plus placebo, -11.4 with sertraline plus placebo, and -10.5 with placebo. In Trial 071, the least squares mean change was -19.2 with brexpiprazole in combination with sertraline (p=0.0007 versus sertraline plus placebo) and -13.6 with sertraline plus placebo.

在试验061中，CAPS-5总分随机化（第1周）的最小二乘平均变化为-16.4，布瑞哌唑联合舍曲林（与舍曲林加安慰剂相比p=0.011），布瑞哌唑加安慰剂为-12.2，舍曲林加安慰剂为-11.4，安慰剂为-10.5。在试验071中，brexpiprazole联合舍曲林的最小二乘平均变化为-19.2（相对于舍曲林加安慰剂，p=0.0007），舍曲林加安慰剂的最小二乘平均变化为-13.6。

In Trial 072, the least mean change was -16.5 with brexpiprazole 2 mg/day in combination with sertraline (p=0.52 versus sertraline plus placebo), -18.3 with brexpiprazole 3 mg/day in combination with sertraline (p=0.66 versus sertraline plus placebo), and -17.6 with sertraline plus placebo.1.

在试验072中，brexpiprazole 2 mg/天联合舍曲林（与舍曲林加安慰剂相比p=0.52），brexpiprazole 3 mg/天联合舍曲林（与舍曲林加安慰剂相比p=0.66），最小平均变化为-16.5，舍曲林加安慰剂为-17.6。

“Lack of recognition and misdiagnosis of PTSD can result in ineffective management, with the average time from onset of symptoms to treatment being 12 years,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. “These findings represent a remarkable advancement in managing the PTSD symptoms of those affected by this chronically misunderstood and prevalent psychiatric disorder.”.

大冢执行副总裁兼首席医疗官、医学博士约翰·克劳斯（JohnKraus）表示：“缺乏对创伤后应激障碍的认识和误诊可能导致管理不力，从症状发作到治疗的平均时间为12年。”。“这些发现代表了在管理这种长期被误解和普遍存在的精神疾病患者的创伤后应激障碍症状方面取得的显着进步。”。

“With approximately 13 million people in the U.S. suffering from PTSD in a given year, these data are crucial to bringing forward a potential new treatment option,” said Johan Luthman, Ph.D., executive vice president, Lundbeck research & development. “We’re hopeful that brexpiprazole in combination with sertraline can become an approved treatment option for appropriate patients living with PTSD.”.

伦贝克研究与发展执行副总裁约翰·卢特曼博士说：“在特定年份，美国约有1300万人患有创伤后应激障碍，这些数据对于提出潜在的新治疗选择至关重要。”。“我们希望brexpiprazole联合舍曲林可以成为适当的PTSD患者的批准治疗选择。”。

About CAPS-5

关于CAPS-5

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The interview consists of 30 items, with a higher score indicating a worse outcome.4.

临床医生管理的DSM-5创伤后应激障碍量表（CAPS-5）是一种结构化访谈，旨在评估精神障碍诊断和统计手册第5版（DSM-5）定义的创伤后应激障碍诊断状态和症状严重程度。面试由30个项目组成，分数越高表示结果越差。

About Post-Traumatic Stress Disorder

关于创伤后应激障碍

PTSD is one of the most common mental health disorders in the United States, with approximately five percent of the population affected during a given year.5,6,9-11 It may occur in people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An individual may experience this as emotionally or physically harmful or life-threatening and may affect mental, physical, social, and/or spiritual well-being.

创伤后应激障碍（PTSD）是美国最常见的心理健康障碍之一，在特定年份中约有5%的人口受到影响。5,6,9-11它可能发生在经历或目睹创伤事件，一系列事件或一系列情况的人身上。个人可能会在情绪上或身体上受到伤害或危及生命，并可能影响心理，身体，社交和/或精神健康。

Examples include physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, historical trauma, intimate partner violence and bullying.7,12.

例子包括身体/性侵犯、自然灾害、严重事故、恐怖行为、战争/战斗、历史创伤、亲密伴侣暴力和欺凌。7,12。

Symptoms of PTSD are generally grouped into four types: intrusion (re-experiencing), avoidance, negative cognitions and mood, and marked alterations in arousal and reactivity.5,8 Symptoms can vary over time or vary from person to person.7 Symptoms usually begin within 3 months of the traumatic incident, but they sometimes emerge later.

创伤后应激障碍的症状通常分为四种类型：入侵（重新体验），回避，负面认知和情绪，以及唤醒和反应的显着改变[5,8]。症状可能随时间变化或因人而异[7]。症状通常在创伤事件发生后3个月内开始，但有时会出现较晚。

To meet the criteria for PTSD diagnosis, symptoms must last longer than one month, and they must be severe enough to interfere with aspects of daily life, such as relationships or work. Symptoms also must not be due to medications, substance use, or a medical condition.5 Guideline recommended first-line treatment includes psychotherapy (e.g., cognitive behavioral therapy) and first line pharmacotherapy options include certain antidepressants.13.

为了达到创伤后应激障碍的诊断标准，症状必须持续一个月以上，并且必须严重到足以干扰日常生活的各个方面，如人际关系或工作。症状也不能是由于药物，物质使用或医疗状况引起的。5指南推荐的一线治疗包括心理治疗（例如认知行为治疗），一线药物治疗选择包括某些抗抑郁药。

About the Studies

关于研究

Trials 331-201-061 (NCT03033069), 331-201-00071 (NCT04124614) and 331-201-00072 (NCT04174170) were designed to evaluate the efficacy, safety and tolerability of treatment with brexpiprazole in combination with sertraline in adults with PTSD. The trial populations included male and female patients, aged 18-65 years (inclusive), with a diagnosis of PTSD according to the DSM-5 and confirmed by the Mini International Neuropsychiatric Interview.

试验331-201-061（NCT03033069），331-201-00071（NCT04124614）和331-201-00072（NCT04174170）旨在评估brexpiprazole联合舍曲林治疗成人创伤后应激障碍的疗效，安全性和耐受性。试验人群包括年龄在18-65岁（包括18-65岁）的男性和女性患者，根据DSM-5诊断为PTSD，并经迷你国际神经精神病学访谈证实。

The trials consisted of a 1-week double-blind placebo run-in period followed by 11 weeks of double-blind randomized treatment for a continuous 12-week double-blind treatment period with a 21-day follow-up. Trial 331-201-061 was a 4-arm, double-blind, flexible-dose trial in which patients were randomized to receive flexible-dose brexpiprazole 1-3 mg/day plus sertraline 100-200 mg/day, flexible-dose brexpiprazole 1-3 mg/day plus placebo, flexible-dose sertraline 100-200 mg/day plus placebo, or placebo (double dummy) during the 11-week randomized treatment period.

试验包括为期1周的双盲安慰剂磨合期，然后进行11周的双盲随机治疗，连续12周的双盲治疗期，随访21天。试验331-201-061是一项4臂，双盲，灵活剂量的试验，其中患者被随机分配接受灵活剂量的brexpiprazole 1-3 mg/天加舍曲林100-200 mg/天，灵活剂量的brexpiprazole 1-3 mg/天加安慰剂，灵活剂量舍曲林100-200 mg/天加安慰剂或安慰剂（双模拟）在11周的随机治疗期间。

Trial 331-201-00071 was a 2-arm, double-blind, flexible-dose trial in which patients were randomized to receive either flexible-dose brexpiprazole 2-3 mg/day plus sertraline 150 mg/day or sertraline 150 mg/day plus placebo during the 11-week randomized treatment period. Trial 331-201-00072 was a 3-arm, double-blind, fixed-dose trial in which patients were randomized to receive either fixed-dose brexpiprazole 2 mg/day plus sertraline 150 mg/day, brexpiprazole 3 mg/day plus sertraline 150 mg/day, or sertraline 150 mg/day plus placebo during the 11-week randomized treatment period.

试验331-201-00071是一项双臂，双盲，灵活剂量的试验，在11周的随机治疗期间，患者被随机分配接受灵活剂量的brexpiprazole 2-3 mg/天加舍曲林150 mg/天或舍曲林150 mg/天加安慰剂。试验331-201-00072是一项三臂双盲固定剂量试验，患者在11周的随机治疗期间随机接受固定剂量的brexpiprazole 2 mg/天加舍曲林150 mg/天，brexpiprazole 3 mg/天加舍曲林150 mg/天，或舍曲林150 mg/天加安慰剂。

The primary outcome in all trials was the change from randomization to week 10 in the CAPS-5 total score; in Trials 331-201-00071 and 331-201-00072 patients had to meet blinded criteria at the week 1 v.

所有试验的主要结果是CAPS-5总分从随机化到第10周的变化；在试验331-201-00071和331-201-00072中，患者在第1周必须符合盲法标准。

About Brexpiprazole

布瑞哌唑

Brexpiprazole was approved in the U.S. in 2015, as an adjunctive therapy to antidepressants in adults with MDD and as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in the U.S. for the treatment of agitation associated with dementia due to Alzheimer's disease, in May 2023.

2015年，Brexpiprazole在美国获得批准，作为MDD成人抗抑郁药的辅助治疗和成人精神分裂症的治疗。最近，布瑞哌唑于2023年5月在美国被批准用于治疗阿尔茨海默氏病引起的痴呆症引起的躁动。

Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively. It was approved by the Ministry of Health, Labour and Welfare in Japan and by the European Medicines Agency in 2018 for the treatment of schizophrenia.3.

Brexpiprazole也分别于2017年和2019年被加拿大卫生部批准用于精神分裂症和MDD的辅助治疗。2018年，它被日本厚生劳动省和欧洲药品管理局批准用于治疗精神分裂症。

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown. Brexpiprazole has high receptor binding affinity to norepinephrine, serotonin and dopamine receptors. It is an antagonist at norepinephrine α1B and α2C receptors and serotonin 5-HT2A receptors, as well as a partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors.14,15.

布雷匹唑是大冢发现的，大冢和伦贝克正在共同开发。brexpiprazole的作用机制尚不清楚。布瑞哌唑对去甲肾上腺素、5-羟色胺和多巴胺受体具有很高的受体结合亲和力。它是去甲肾上腺素α1B和α2C受体和5-羟色胺5-HT2A受体的拮抗剂，以及5-羟色胺5-HT1A和多巴胺D2受体的部分激动剂活性[14,15]。

INDICATIONS and IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole)

REXULTI®（brexpiprazole）的适应症和重要安全信息

INDICATIONS: REXULTI is a prescription medicine used to treat:

适应症：REXULTI是一种处方药，用于治疗：

Major depressive disorder (MDD): REXULTI is used with antidepressant medicines, when your healthcare provider determines that an antidepressant alone is not enough to treat your depression.

重度抑郁症（MDD）：当您的医疗保健提供者确定单独使用抗抑郁药不足以治疗您的抑郁症时，REXULTI与抗抑郁药一起使用。

Schizophrenia

精神分裂症

It is not known if REXULTI is safe and effective in people under 18 years of age.

目前尚不清楚REXULTI对18岁以下人群是否安全有效。

IMPORTANT SAFETY INFORMATION:

重要安全信息：

Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of patients with dementia-related psychosis..

痴呆相关精神病老年人死亡风险增加。像REXULTI这样的药物会增加由于困惑和记忆丧失（痴呆症）而失去现实（精神病）的老年人的死亡风险。REXULTI未被批准用于治疗痴呆相关精神病患者。。

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions.

抗抑郁药物可能会在治疗的头几个月内增加一些儿童，青少年或年轻人的自杀念头或行为。抑郁症和其他严重的精神疾病是自杀念头或行为的最重要原因。有些人可能有自杀念头或行为的风险特别高。

Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms immediately to the doctor.

服用抗抑郁药的患者及其家人或护理人员应注意新的或恶化的抑郁症状，尤其是情绪，行为，思想或感觉的突然变化。当开始服用抗抑郁药或改变剂量时，这一点非常重要。立即向医生报告这些症状的任何变化。

REXULTI is not approved for the treatment of people younger than 18 years of age..

REXULTI未被批准用于治疗18岁以下的人。。

Contraindication: Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI. Allergic reactions have included rash, facial swelling, hives and itching, and anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue..

禁忌症：如果您对brexpiprazole或REXULTI中的任何成分过敏，请不要服用REXULTI。过敏反应包括皮疹、面部肿胀、荨麻疹和瘙痒，以及过敏反应，可能包括呼吸困难、胸闷以及口腔、面部、嘴唇或舌头肿胀。。

REXULTI may cause serious side effects, including:

REXULTI可能会引起严重的副作用，包括：

Stroke in elderly people (cerebrovascular problems) that can lead to death.

老年人中风（脑血管问题）可能导致死亡。

Neuroleptic Malignant Syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death.

抗精神病药物恶性综合征（NMS）：如果您有以下部分或全部症状，请立即告诉您的医疗保健提供者：高烧，肌肉僵硬，精神错乱，出汗，脉搏，心率和血压变化。这些症状可能是一种罕见而严重的疾病，可能导致死亡。

Call your healthcare provider right away if you have any of these symptoms..

如果您有任何这些症状，请立即致电您的医疗保健提供者。。

Uncontrolled body movements (tardive dyskinesia). REXULTI may cause movements that you cannot control in your face, tongue or other body parts. Tardive dyskinesia may not go away, even if you stop taking REXULTI. Tardive dyskinesia may also start after you stop taking REXULTI.

不受控制的身体运动（迟发性运动障碍）。REXULTI可能会导致面部、舌头或其他身体部位无法控制的运动。迟发性运动障碍可能不会消失，即使你停止服用REXULTI。停止服用REXULTI后，迟发性运动障碍也可能开始。

Problems with your metabolism such as:

新陈代谢问题，例如：

high blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or having a family history of diabetes), your healthcare provider should check your blood sugar before you start taking REXULTI and during your treatment..

高血糖（高血糖）：服用雷克多的人可能会出现血糖升高。极高的血糖会导致昏迷或死亡。如果您患有糖尿病或糖尿病的危险因素（例如超重或有糖尿病家族史），您的医疗保健提供者应在开始服用雷克多之前和治疗期间检查您的血糖。。

Call your healthcare provider if you have any of these symptoms of high blood sugar while taking REXULTI:

如果您在服用REXULTI时出现任何这些高血糖症状，请致电您的医疗保健提供者：

feel very thirsty

感到非常口渴

feel very hungry

感觉很饿

feel sick to your stomach

胃部不舒服

feel weak or tired

感到虚弱或疲倦

need to urinate more than usual

需要比平时排尿更多

feel confused, or your breath smells fruity

感到困惑，或者你的呼吸有水果味

increased fat levels (cholesterol and triglycerides) in your blood.

血液中脂肪水平（胆固醇和甘油三酯）升高。

weight gain. You and your healthcare provider should check your weight regularly.

体重增加。你和你的医疗保健提供者应该定期检查你的体重。

Low white blood cell count

白细胞计数低

Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

血压降低（体位性低血压）。当你从坐着或躺着的姿势起得太快时，你可能会感到头晕或昏厥。

Seizures (convulsions)

癫痫发作（抽搐）

Problems controlling your body temperature so that you feel too warm. Avoid getting over-heated or dehydrated while taking REXULTI.

控制体温的问题使你感到太热。服用REXULTI时避免过热或脱水。

Do not over-exercise.

不要过度锻炼。

Stay out of the sun. Do not wear too much or heavy clothing.

远离阳光。不要穿太多或太重的衣服。

In hot weather, stay inside in a cool place if possible.

天气炎热时，尽可能呆在阴凉的地方。

Drink plenty of water.

多喝水。

Difficulty swallowing that can cause food or liquid to get into your lungs.

吞咽困难，可能导致食物或液体进入肺部。

Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy.

在了解雷克斯多对您的影响之前，请勿驾驶汽车、操作机器或进行其他危险活动。REXULTI可能会让你感到昏昏欲睡。

Avoid drinking alcohol while taking REXULTI.

服用REXULTI时避免饮酒。

Before taking REXULTI, tell your healthcare provider if you:

服用REXULTI之前，如果您：

have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start REXULTI and during your treatment.

患有糖尿病或高血糖或有糖尿病或高血糖家族史。您的医疗保健提供者应该在您开始使用REXULTI之前和治疗期间检查您的血糖。

have high levels of cholesterol, triglycerides, LDL-cholesterol, or low levels of HDL cholesterol

胆固醇、甘油三酯、低密度脂蛋白胆固醇或低密度脂蛋白胆固醇水平高

have or had seizures (convulsions)

癫痫发作（抽搐）

have or had low or high blood pressure

患有或患有低血压或高血压

have or had heart problems or a stroke

有或有心脏问题或中风

have or had a low white blood cell count

白细胞计数低

are pregnant or plan to become pregnant. It is not known if REXULTI may harm your unborn baby. Using REXULTI in the last trimester of pregnancy may cause muscle movement problems, medicine withdrawal symptoms, or both of these in your newborn.

怀孕或计划怀孕。目前尚不清楚REXULTI是否会伤害您的未出生婴儿。在怀孕的最后三个月使用REXULTI可能会导致新生儿出现肌肉运动问题，停药症状或两者兼而有之。

If you become pregnant while taking REXULTI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/

如果您在服用REXULTI时怀孕，请与您的医疗保健提供者联系，向国家妊娠登记处登记非典型抗精神病药物。您可以拨打1-866-961-2388或访问http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/

are breastfeeding or plan to breastfeed. It is not known if REXULTI passes into your breast milk. You and your healthcare provider should decide if you will take REXULTI or breastfeed.

正在母乳喂养或计划母乳喂养。目前尚不清楚REXULTI是否会进入你的母乳。您和您的医疗保健提供者应该决定您是服用REXULTI还是母乳喂养。

Tell your healthcare provider about all the medicines you take or recently have taken, including prescription medicines, over-the-counter medicines, vitamins and herbal supplements.

告诉你的医疗保健提供者你服用或最近服用的所有药物，包括处方药、非处方药、维生素和草药补充剂。

REXULTI and other medicines may affect each other causing possible serious side effects. REXULTI may affect the way other medicines work, and other medicines may affect how REXULTI works.

REXULTI和其他药物可能会相互影响，导致可能的严重副作用。REXULTI可能会影响其他药物的工作方式，其他药物可能会影响REXULTI的工作方式。

Your healthcare provider can tell you if it is safe to take REXULTI with your other medicines. Do not start or stop any medicines while taking REXULTI without talking to your healthcare provider first.

您的医疗保健提供者可以告诉您与其他药物一起服用REXULTI是否安全。服用REXULTI时，未事先与您的医疗保健提供者交谈，请勿开始或停止任何药物。

The most common side effects of REXULTI include weight gain and an inner sense of restlessness such as feeling like you need to move.

REXULTI最常见的副作用包括体重增加和内心烦躁不安，例如感觉需要运动。

Tell your healthcare provider if you experience abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia.

如果你遇到异常的肌肉痉挛或收缩，请告诉你的医疗保健提供者，这可能是一种称为肌张力障碍的疾病的迹象。

These are not all the possible side effects of REXULTI. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about your health or medicines, including side effects.

这些并不是REXULTI所有可能的副作用。有关更多信息，请咨询您的医疗保健提供者或药剂师。给你的医生打电话咨询你的健康或药物，包括副作用。

You are encouraged to report side effects of REXULTI (brexpiprazole), please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

鼓励您报告雷克多（brexpiprazole）的副作用，请致电1-800-438-9927联系大冢美国制药公司或致电1-800-FDA-1088（www.FDA.gov/medwatch）联系FDA。

Please read U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNING, and Medication Guide, for REXULTI

请阅读REXULTI的美国完整处方信息，包括盒装警告和药物指南

About Otsuka

关于大冢

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health..

大冢制药有限公司是一家全球性的医疗保健公司，其企业理念是：大冢-人们创造新产品以改善全球健康。大冢研究、开发、制造和销售创新产品，重点是满足未满足医疗需求的医药产品和维持日常健康的营养保健产品。。

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does..

在制药领域，大冢在精神、肾脏和心血管健康等具有挑战性的领域处于领先地位，并在肿瘤学和包括结核病（一个重要的全球公共卫生问题）在内的一些未得到充分解决的疾病方面拥有额外的研究项目。这些承诺说明大冢在本质上是一家“大风险”公司，在其所做的每件事中都运用了年轻的创造力。。

Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs..

大冢于1973年在美国成立了分支机构，如今其美国分支机构包括大冢制药开发与商业化公司（OPDC）和大冢美国制药公司（OAPI）。这两家公司在美国的2250名员工利用尖端技术开发心理健康和肾脏病领域的药物并将其商业化，以满足未满足的医疗需求。。

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

OPDC和OAPI是大冢制药有限公司的间接子公司，大冢制药有限公司是大冢控股有限公司的子公司，总部位于日本东京。大冢集团在全球拥有34400名员工，2023年的合并销售额约为142亿美元。

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/.

所有大冢的故事都是从走人迹罕至的路开始的。有关大冢在美国的更多信息，请访问www.Otsuka-us.com，并通过LinkedIn和Twitter@OtsukaUS与我们联系。大冢制药有限公司的全球网站可访问https://www.otsuka.co.jp/en/.

About Lundbeck

关于伦贝克

Lundbeck Pharmaceuticals LLC is a wholly owned US subsidiary of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC), a global biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases..

Lundbeck Pharmaceuticals LLC是H.Lundbeck a/S（HLUNa/HLUNb，HLUNa DC/HLUNb DC）在美国的全资子公司，这是一家专注于神经科学的全球生物制药公司，在改善神经和精神疾病患者的生活方面拥有70多年的经验。。

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options. Our goal is to create long term value and make a positive contribution to people and societies, everywhere we operate.

作为一名专注的创新者，我们致力于研发项目，以应对一些最复杂的挑战。我们针对几乎没有治疗选择的人群开发了变革性药物。我们的目标是创造长期价值，为我们运营的任何地方的人民和社会做出积极贡献。

We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of..

我们致力于消除耻辱和歧视，并采取行动改善我们服务的人和我们所属社区的健康公平。。

Too many people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions.

全世界有太多人患有脑部疾病，这种复杂的疾病通常是其他人看不见的，但却给个人、家庭和社会带来了巨大的损失。我们致力于消除对患有脑部疾病的人的污名化和歧视，并倡导更广泛的社会接受患有脑部健康状况的人。

Every day, we strive for improved treatment and a better life for people living with brain disease..

每天，我们都在为患有脑部疾病的人争取更好的治疗和更好的生活。。

We have approximately 5,700 employees, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

我们拥有大约5700名员工，我们的产品遍布100多个国家。我们的研究项目解决了神经科学中一些最复杂的挑战，我们的管道专注于为几乎没有治疗选择的脑部疾病提出变革性治疗方法。

We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy..

我们在丹麦和美国拥有研究设施，我们的生产设施位于丹麦、法国和意大利。。

Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S, including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. With a workforce of more than 1,000 colleagues, Lundbeck US is deeply committed to enhancing the lives of patients, families, and caregivers through focused innovation in neuroscience.

Lundbeck US由H.Lundbeck A/S的全资美国子公司组成，包括Lundbeck LLC和Lundbeck Pharmaceuticals LLC。Lundbeck US拥有1000多名员工，通过专注于神经科学的创新，致力于改善患者，家属和护理人员的生活。