{"id":51455,"date":"2022-12-01T15:02:16","date_gmt":"2022-12-01T14:02:16","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/otsuka-and-sunovion-initiate-clinical-development-of-ulotaront-for-the-adjunctive-treatment-of-major-depressive-disorder\/"},"modified":"2022-12-01T15:02:16","modified_gmt":"2022-12-01T14:02:16","slug":"otsuka-and-sunovion-initiate-clinical-development-of-ulotaront-for-the-adjunctive-treatment-of-major-depressive-disorder","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/otsuka-and-sunovion-initiate-clinical-development-of-ulotaront-for-the-adjunctive-treatment-of-major-depressive-disorder\/","title":{"rendered":"Otsuka and Sunovion Initiate Clinical Development of Ulotaront for the Adjunctive Treatment of Major Depressive Disorder"},"content":{"rendered":"
\n

\nFirst Trial to Study a Trace Amine-Associated Receptor 1 (TAAR1) Agonist in Major Depressive Disorder (MDD)<\/i>\n<\/p>\n

PRINCETON, N.J. & MARLBOROUGH, Mass.–(BUSINESS WIRE)–Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the first patient has been enrolled in a Phase 2\/3 clinical study to evaluate ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A<\/sub> agonist activity, as an adjunctive therapy in the treatment of adults living with major depressive disorder (MDD). Ulotaront, which is also being evaluated in Phase 3 clinical development for the treatment of schizophrenia, is the first TAAR1 agonist to be studied as an adjunctive therapy in the treatment of MDD.\n<\/p>\n

<\/a><\/p>\n

\nThe global, multicenter, randomized, double-blind, placebo-controlled study is designed to examine the efficacy, safety and tolerability of ulotaront as an adjunctive therapy in the treatment of adults with MDD. Patients with an inadequate response to current antidepressant treatment will be randomized to receive ulotaront or placebo in addition to their antidepressant therapy.\n<\/p>\n

\nThe primary endpoint for the study is the reduction of depressive symptoms, as measured by the change from baseline in Montgomery-\u00c5sberg Depression Rating Scale (MADRS) total score, compared to placebo at the end of the study.\n<\/p>\n

\n\u201cMDD is a disabling mental health condition that often requires a combination of first-line antidepressant medication and adjunctive treatments to alleviate symptoms,\u201d said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. \u201cEven with available approaches, many patients do not achieve optimal responses to treatment, in part due to the heterogeneous nature of the condition, highlighting the need for new and different treatment modalities.\u201d\n<\/p>\n

\nDepressive disorders, including MDD, affect roughly 280 million people worldwide.1<\/sup> MDD is anticipated to rank first in global burden of disease by 2030.2<\/sup>\n<\/p>\n

\n\u201cThe initiation of the Phase 2\/3 study evaluating the use of ulotaront as an adjunctive treatment of major depressive disorder is an important step towards exploring the full medical potential of this novel TAAR1 agonist,\u201d said Armin Szegedi, M.D., Ph.D., senior vice president, chief medical officer at Sunovion. \u201cWe have been encouraged by the pre-clinical data showing that ulotaront could have benefits for those living with mood disorder and look forward to enhancing the understanding of this innovative compound in collaboration with Otsuka.\u201d\n<\/p>\n

\nAbout Ulotaront (SEP-363856)
\n
<\/b>Ulotaront, a TAAR1 agonist with 5-HT1A<\/sub> agonist activity, is currently under investigation for the treatment of schizophrenia as well as the adjunctive treatment of MDD, with additional indications under consideration.\n<\/p>\n

\nUlotaront was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in 2019. Ulotaront is the first TAAR1 agonist to enter into Phase 3 clinical studies in adults and adolescents (13 to 17 years) with schizophrenia. It\u2019s also the first TAAR1 agonist to enter into a Phase 2\/3 clinical study as an adjunctive therapy for MDD.\n<\/p>\n

\nUlotaront is being jointly developed and commercialized as part of a collaboration between Otsuka Pharmaceutical Co., Ltd, Sunovion, and its parent company Sumitomo Pharma Co., Ltd. Sunovion discovered ulotaront in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube\u00ae<\/sup> platform and associated artificial intelligence algorithms.\n<\/p>\n

\nAbout Major Depressive Disorder
\n
<\/b>Major depressive disorder is a chronic debilitating disease characterized by symptoms that last at least two weeks causing significant functional impairment. While symptoms of depression differ for each individual, some common symptoms may include a depressed mood that affects how a person thinks, feels and behaves, or a loss of interest in activities an individual once enjoyed.\n<\/p>\n

\nAbout Otsuka
\n
<\/b>Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: \u201cOtsuka\u2013people creating new products for better health worldwide.\u201d 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.\n<\/p>\n

\nIn 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 \u201cbig venture\u201d company at heart, applying a youthful spirit of creativity in everything it does.\n<\/p>\n

\nOtsuka 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\u2019 2,000 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs.\n<\/p>\n

\nOPDC 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 13.6 billion in 2021.\n<\/p>\n

\nAll Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com<\/a><\/b> and connect with us on LinkedIn and Twitter at @OtsukaUS<\/b>. Otsuka Pharmaceutical Co., Ltd.\u2019s global website is accessible at www.otsuka.co.jp\/en<\/b><\/a>.\n<\/p>\n

\nAbout Sunovion Pharmaceuticals Inc. (Sunovion)
\n
<\/b>Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion\u2019s vision is to lead the way to a healthier world. The company\u2019s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.\n<\/p>\n

\nHeadquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Pharma Co., Ltd. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc. Additional information can be found on the company\u2019s websites: www.sunovion.com<\/b><\/a> and www.sunovion.ca<\/b><\/a>. Connect with Sunovion on Twitter<\/b><\/a>, LinkedIn<\/b><\/a>, Facebook<\/b><\/a> and YouTube<\/b><\/a>.\n<\/p>\n

\nAbout Sumitomo Pharma Co., Ltd.
\n
<\/b>Sumitomo Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine\/Cell therapy field, which have been designated as the focus therapeutic areas. Today, Sumitomo Pharma has about 7,000 employees worldwide. Additional information about Sumitomo Pharma is available through its corporate website at https:\/\/www.sumitomo-pharma.com<\/b><\/a>.\n<\/p>\n

\nSUNOVION is a registered trademark of Sumitomo Pharma Co., Ltd.\n<\/p>\n

\nSunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.\n<\/p>\n

\n\u00a9 2022 Sunovion Pharmaceuticals Inc. All rights reserved.\n<\/p>\n

\nFor a copy of this release, visit Sunovion\u2019s website at www.sunovion.com<\/b><\/a> <\/b>and Otsuka\u2019s website at www.otsuka-us.com<\/b><\/a>.\n<\/p>\n

\nReferences:\n<\/p>\n

\n1<\/sup>Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry<\/i>. 2022;9(2):137-150.
\n
2<\/sup>Malhi G, and Mann J. Depression. Lancet<\/i>;392(10161):2299-2312. doi: 10.1016\/S0140-6736(18)31948-2.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nOtsuka in U.S.<\/b>
Robert Murphy
\n
Senior Director – Head, External Communications
\n
Otsuka America Pharmaceutical, Inc.
\n
609-249-7262
\n
robert.murphy@otsuka-us.com<\/b><\/a>\n<\/p>\n

\nO<\/b>tsuka Outside the U.S.<\/b>
Jeffrey Gilbert
\n
Leader, Pharmaceutical PR
\n
Otsuka Pharmaceutical, Co., Ltd.
\n
gilbert.jeffrey@otsuka.co.jp<\/b><\/a>\n<\/p>\n

\nFor Sunovion<\/b>
Kirsten Fallon
\n
Director, Portfolio Communications
\n
Sunovion Pharmaceuticals Inc.
\n
774-369-7116
\n
kirsten.fallon@sunovion.com<\/b><\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

First Trial to Study a Trace Amine-Associated Receptor 1 (TAAR1) Agonist in Major Depressive Disorder (MDD) PRINCETON, N.J. & MARLBOROUGH, Mass.–(BUSINESS WIRE)–Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the first patient has been enrolled in a Phase 2\/3 clinical study to evaluate ulotaront (SEP-363856), a trace amine-associated … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-51455","6":"format-standard","7":"category-industry"},"yoast_head":"\nOtsuka and Sunovion Initiate Clinical Development of Ulotaront for the Adjunctive Treatment of Major Depressive Disorder - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/otsuka-and-sunovion-initiate-clinical-development-of-ulotaront-for-the-adjunctive-treatment-of-major-depressive-disorder\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Otsuka and Sunovion Initiate Clinical Development of Ulotaront for the Adjunctive Treatment of Major Depressive Disorder - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"First Trial to Study a Trace Amine-Associated Receptor 1 (TAAR1) Agonist in Major Depressive Disorder (MDD) PRINCETON, N.J. & MARLBOROUGH, Mass.–(BUSINESS WIRE)–Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the first patient has been enrolled in a Phase 2\/3 clinical study to evaluate ulotaront (SEP-363856), a trace amine-associated ... 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(Otsuka) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the first patient has been enrolled in a Phase 2\/3 clinical study to evaluate ulotaront (SEP-363856), a trace amine-associated ... 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