PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click Therapeutics, Inc., (Click) announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn™ (developed as CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication.

普林斯顿，新泽西州和纽约州——（商业新闻短讯）——大冢制药有限公司（Otsuka）和Click Therapeutics，Inc.，（Click）宣布，美国食品和药物管理局（FDA）已经批准Rejoyn™（开发为CT-152），这是第一个被授权用于治疗重度抑郁症（MDD）症状的处方数字治疗药物，作为临床医生管理的门诊护理的辅助手段，用于22岁及以上服用抗抑郁药物的MDD成年患者。

Rejoyn is intended to reduce MDD symptoms.

Rejoyn旨在减轻MDD症状。

Rejoyn is a six-week treatment program designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for the brain and brief therapeutic lessons. Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.

Rejoyn是一个为期六周的治疗计划，旨在通过临床验证的大脑认知情绪训练练习和简短的治疗课程相结合，帮助增强对情绪的认知控制。与健康应用程序不同，Rejoyn应用程序是FDA授权的医疗设备，由医疗保健专业人员开具处方。

“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder (MDD) symptoms that complements the current standard of care,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “While traditional approaches are often effective, many are left with only a partial response to treatment.

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：“雷乔恩（Rejoyn）代表了一种新颖而令人兴奋的辅助治疗选择，可以解决严重抑郁症（MDD）症状，补充当前的护理标准。”。“虽然传统方法通常是有效的，但许多方法对治疗只有部分反应。

Otsuka has a long, unwavering commitment to addressing the unmet needs of people living with mental illnesses and the clearance of Rejoyn is an example of delivering on that promise. We are deeply grateful to the trial participants, clinicians, and everyone at Otsuka and Click Therapeutics, who helped Rejoyn reach this important milestone.”

大冢长期以来坚定不移地致力于解决精神疾病患者未满足的需求，而Rejoyn的清除就是实现这一承诺的一个例子。我们非常感谢大冢和Click Therapeutics的试验参与者，临床医生和所有人，他们帮助Rejoyn实现了这一重要里程碑。”

The clearance of Rejoyn is based on data from the Mirai study, a 13-week pivotal, multicenter, remote, double-blinded, randomized, controlled trial of 386 participants, aged 22 to 64, diagnosed with MDD who were on antidepressant medication for the treatment of depression. In the trial, patients were randomized to receive either Rejoyn or a sham control app.

Rejoyn的清除是基于Mirai研究的数据，这是一项为期13周的关键性，多中心，远程，双盲，随机对照试验，共有386名年龄在22至64岁之间的参与者被诊断患有MDD，他们正在服用抗抑郁药物治疗抑郁症。在试验中，患者被随机分配接受Rejoyn或假对照应用程序。

Individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline. Symptom improvement was consistently observed across multiple patient and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S).

接受Rejoyn治疗的患者的抑郁症状严重程度比基线有所改善。在多个患者和临床医生报告的量表中一致观察到症状改善，包括蒙哥马利抑郁评定量表（MADRS），患者健康问卷九项抑郁量表（PHQ-9）和临床总体印象严重程度量表（CGI-S）。

One month after completing the six-week treatment program, participants in the Rejoyn group showed continued improvement. No side effects were assessed as related to Rejoyn during the trial. Full clinical data may be found as part of the Clinician Brief Summary.

在完成为期六周的治疗计划一个月后，Rejoyn组的参与者表现出持续的改善。在试验期间，没有评估与Rejoyn相关的副作用。完整的临床数据可以作为临床医生简要总结的一部分找到。

Rejoyn offers a novel approach to the treatment of depression symptoms as it is designed to target neural networks affected by depression and is hypothesized to leverage the brain’s inherent neuroplasticity to alter those connections leading to symptom reduction over time. Clinical research has long shown that chemical imbalances are not the only cause of depression, though most common treatments target these neurochemical abnormalities.

Rejoyn提供了一种治疗抑郁症症状的新方法，因为它旨在针对受抑郁症影响的神经网络，并假设利用大脑固有的神经可塑性来改变这些连接，从而随着时间的推移症状减轻。长期以来，临床研究表明，化学失衡并不是抑郁症的唯一原因，尽管大多数常见的治疗方法都针对这些神经化学异常。

For some people with depression, the parts of the brain responsible for emotion recognition and processing and the parts responsible for cognition do not communicate properly, making emotional regulation more difficult.1.

对于一些抑郁症患者来说，大脑中负责情绪识别和处理的部分以及负责认知的部分不能正确沟通，这使得情绪调节更加困难。

“Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression,” said Brian Iacoviello, Ph.D., assistant professor, department of psychiatry, Icahn School of Medicine at Mount Sinai, scientific advisor at Click Therapeutics and a co-inventor of Emotional Faces Memory Task (EFMT).

西奈山伊坎医学院精神病学系助理教授、Click Therapeutics的科学顾问、情绪面孔记忆任务（EFMT）的共同发明人Brian Iacoviello博士说：“Rejoyn有一种神经调节机制，旨在通过提供个性化、一致的大脑训练练习来帮助改善受抑郁症影响的大脑区域的联系，从而起到大脑物理疗法的作用。”

“When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together and symptoms of depression can improve.”

“当建立更强大、更平衡的联系时，大脑中负责处理和调节情绪的区域能够更好地协同工作，抑郁症的症状也会得到改善。”

Rejoyn introduces clinically-validated cognitive emotional brain training exercises (“Emotional Faces Memory Task” or “EFMT”) that were developed and studied by a team of psychologists, psychiatrists and neuroscientists. These brain exercises are designed to target and help alter those neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression.

Rejoyn介绍了经过临床验证的认知情绪大脑训练练习（“情绪面孔记忆任务”或“EFMT”），这些练习是由心理学家，精神病医生和神经科学家团队开发和研究的。这些大脑练习旨在针对并帮助改变适当处理情绪所需的神经联系，以减轻抑郁症状。

“Only a third of patients diagnosed with depression and who receive antidepressants as their first-line treatment, are successful. These patients need new options that capitalize on proven-effective treatment strategies,” said David Benshoof Klein, Co-founder and chief executive officer at Click Therapeutics.

Click Therapeutics联合创始人兼首席执行官David Benshoof Klein说：“只有三分之一被诊断患有抑郁症并接受抗抑郁药作为一线治疗的患者取得了成功。这些患者需要新的选择，以利用已证明有效的治疗策略。”

“The clearance of Rejoyn signals a fundamental change in how clinicians can treat symptoms of major depressive disorder. It provides hope for those who are looking for new treatment options, especially one that is easily accessible through the device in the palm of your hand.”

“Rejoyn的清除标志着临床医生如何治疗重度抑郁症症状的根本改变。它为那些正在寻找新治疗选择的人提供了希望，特别是那些可以通过手掌中的设备轻松获得的治疗选择。”

Rejoyn requires a prescription from a healthcare provider and is expected to be available for download from app stores for iOS® and Android™ operating systems in the latter half of 2024. To learn more about Rejoyn and sign up for updates regarding its availability, go to www.rejoyn.com. Healthcare providers can visit www.rejoynhcp.com..

Rejoyn需要医疗保健提供商的处方，预计将于2024年下半年从iOS®和Android™操作系统的应用商店下载。要了解有关Rejoyn的更多信息并注册有关其可用性的更新，请访问www.Rejoyn.com。医疗保健提供者可以访问www.rejoynhcp.com。。

About the Mirai Clinical Study

关于Mirai临床研究

The indications for use of Rejoyn are supported by the results from the Mirai Trial, a pivotal 13-week multicenter, remote, double-blinded, randomized controlled trial in adult participants diagnosed with MDD who were on antidepressant medication for the treatment of depression. The primary efficacy endpoint was the change from baseline to week six in the MADRS total score.

Mirai试验的结果支持了使用Rejoyn的适应症，该试验是一项为期13周的关键性多中心，远程，双盲，随机对照试验，用于诊断患有MDD的成年参与者，他们正在服用抗抑郁药物治疗抑郁症。主要疗效终点是MADRS总分从基线到第六周的变化。

Effectiveness was also evaluated using the PHQ-9 and the CGI-S scale.

还使用PHQ-9和CGI-S量表评估了有效性。

In the trial, a total of 386 participants were randomized to receive Rejoyn (194) or a sham control app (192) that resided on the patients’ personal smartphones. The study enrolled patients from 22 to 64 years of age with a current primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and who reported an inadequate response to their current antidepressant medication, defined as <50% reduction in depression symptom severity in the current major depressive episode.

在该试验中，共有386名参与者被随机分配接受Rejoyn（194）或驻留在患者个人智能手机上的假对照应用程序（192）。该研究招募了22至64岁的患者，根据《精神障碍诊断和统计手册》第五版（DSM-5）中的标准，目前主要诊断为MDD，他们报告对目前的抗抑郁药物反应不足，定义为目前重度抑郁发作中抑郁症状严重程度降低50%。

The study included a 3-week screening period, a 6-week treatment period, and a 4-week extension period.

该研究包括3周的筛查期，6周的治疗期和4周的延长期。

Participants in both groups received personalized reminders and text messages throughout the study duration to maintain engagement, and trial visits were conducted remotely by video or telephone. Further, all participants were expected to adhere to their app exercises during the treatment period, and adherence was monitored.

在整个研究期间，两组参与者都收到了个性化的提醒和短信，以保持参与度，并且通过视频或电话远程进行了试验访问。此外，预计所有参与者在治疗期间都会坚持他们的应用程序练习，并监测依从性。

During the trial, no serious treatment emergent adverse events (TEAEs), or discontinuations due to a TEAE, or deaths occurred in the patients receiving Rejoyn..

在试验期间，接受Rejoyn治疗的患者未发生严重的治疗紧急不良事件（TEAE），或因TEAE而停药或死亡。。

About Major Depressive Disorder

关于重度抑郁症

According to the World Health Organization, approximately 280 million people in the world have depression, with 21 million people suffering in the United States alone, as reported by the National Institute of Mental Health.4, 5 MDD is a condition that often requires a combination of first-line antidepressant medication, talk therapy or psychotherapy, and other adjunctive treatments to alleviate symptoms.

据世界卫生组织（World Health Organization）统计，据美国国家心理健康研究所（National Institute of Mental Health）报告，全世界约有2.8亿人患有抑郁症，仅在美国就有2100万人患有抑郁症。4、5 MDD是一种常需结合一线抗抑郁药物、谈话疗法或心理疗法以及其他辅助治疗来缓解症状的疾病。

Even with available approaches, many patients may not achieve optimal responses to treatment, resulting in an unmet need for new and different treatment modalities., 2, 3, 6, 7.

即使有可用的方法，许多患者也可能无法获得最佳的治疗反应，导致对新的不同治疗方式的需求未得到满足。，2、3、6、7。

About Prescription Digital Therapeutics

关于处方数字治疗

Digital therapeutics are health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.8 A prescription digital therapeutic (PDT) is a digital therapeutic only available to patients by a prescription from a healthcare provider.

数字治疗是一种健康软件，旨在通过产生和提供对患者健康具有明显积极治疗影响的医疗干预来治疗或减轻疾病，紊乱，状况或伤害。处方数字治疗（PDT）是一种数字治疗，仅由医疗保健提供者的处方提供给患者。

PDTs can be used independently or in conjunction with medications, devices, or other therapies to optimize patient care under the guidance of their healthcare provider.9As a new modality of treatment, PDTs deliver medical interventions directly to patients from their smartphones using software programs that are subject to clinical evidence requirements and regulatory oversight and are recognized as medical devices by the FDA.

PDT可以独立使用，也可以与药物、设备或其他疗法结合使用，以在其医疗保健提供者的指导下优化患者护理。9作为一种新的治疗方式，PDT使用软件程序直接从智能手机向患者提供医疗干预，该软件程序受到临床证据要求和监管监督，并被FDA认定为医疗设备。

About the Otsuka and Click Therapeutics Collaboration

关于大冢和Click Therapeutics合作

Otsuka America, Inc. (OAI) and Click Therapeutics, Inc., signed a collaboration agreement in 2019 to develop and commercialize prescription digital therapeutics for treatment of MDD, with the intent to address unmet medical needs among this patient population and to improve outcomes. Rejoyn is the first FDA-cleared treatment resulting from this collaboration.

大冢美国公司（OAI）和Click Therapeutics，Inc.于2019年签署了一项合作协议，旨在开发和商业化用于治疗MDD的处方数字疗法，旨在解决该患者群体中未满足的医疗需求并改善结果。Rejoyn是此次合作产生的首个FDA批准的治疗方案。

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，结核病是一个重要的全球公共卫生问题。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’ 2,000 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2000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，以解决未满足的医疗保健需求。

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 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47000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 Click

关于单击

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, we deliver accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand.

Click Therapeutics，Inc.开发、验证和商业化软件，作为未满足医疗需求的人的处方医疗。作为Digital Therapeutics™的领先创新者，我们为您手中的智能手机提供可访问的，经临床验证的，FDA监管的处方治疗。

Our treatments are defined by our commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. We are continuously expanding and refining our shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning.

我们致力于将严格的技术和科学以及以患者为中心的设计应用于开发过程，从而确定了我们的治疗方法。这导致了独特的参与体验，为寻求新治疗选择的患者取得了令人信服的临床结果。我们正在通过新颖的认知、行为和神经调节作用机制以及先进的数据驱动工具（如人工智能和机器学习）不断扩展和改进我们的共享平台技术。

Digital therapeutics under development on our platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, we foster an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in our mission to provide patients everywhere access to safe and effective prescription digital therapeutics.

我们平台上正在开发的数字治疗方法解决了不同领域的治疗需求，包括精神病学，神经病学，肿瘤学，免疫学和心脏代谢疾病的适应症。我们一直被评为最佳工作场所，培养了一支包容性强、多样化的创新人才、临床医生、科学家、研究人员、设计师、技术专家、工程师等，共同致力于为各地的患者提供安全有效的处方数字治疗。