{"id":56237,"date":"2023-04-26T14:05:18","date_gmt":"2023-04-26T12:05:18","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/sunovion-and-otsuka-initiate-clinical-development-of-ulotaront-for-the-treatment-of-generalized-anxiety-disorder\/"},"modified":"2023-04-26T14:05:18","modified_gmt":"2023-04-26T12:05:18","slug":"sunovion-and-otsuka-initiate-clinical-development-of-ulotaront-for-the-treatment-of-generalized-anxiety-disorder","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/sunovion-and-otsuka-initiate-clinical-development-of-ulotaront-for-the-treatment-of-generalized-anxiety-disorder\/","title":{"rendered":"Sunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety Disorder"},"content":{"rendered":"
\n

\n\u2013Approximately 7.5 Million People in The U.S. <\/i>Are Living with Generalized Anxiety Disorder (GAD) 1,2<\/sup>\u2013<\/i><\/p>\n

MARLBOROUGH, Mass. & PRINCETON, N.J.–(BUSINESS WIRE)–#Sunovion<\/a>—Sunovion Pharmaceuticals Inc.<\/a> (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc.<\/a> (Otsuka) today announced that the first patient has been randomized in a Phase 2\/3 clinical study evaluating ulotaront, a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A<\/sub> agonist activity, for the treatment of generalized anxiety disorder (GAD). In addition to GAD, ulotaront is being investigated in late-stage clinical studies for the treatment of schizophrenia and for the adjunctive treatment of major depressive disorder (MDD).<\/p>\n

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

\n\u201cGeneralized anxiety disorder is a chronic condition characterized by excessive anxiety or worries, sleep disturbances, changes in appetite and impairment of social and occupational activities which can have a profound impact on nearly all aspects of an individual\u2019s life,\u201d said Armin Szegedi, M.D., Ph.D., Senior Vice President, Chief Medical Officer at Sunovion. \u201cPreliminary data from preclinical and clinical studies of ulotaront suggest an anxiety-reducing effect, which we aim to understand further in patients with GAD. We believe that ulotaront is a potentially important novel mechanism and therapeutic advance for the treatment of GAD and other serious mental health conditions.\u201d<\/p>\n

\nThe multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study will evaluate ulotaront\u2019s efficacy and safety in people living with GAD. A total of 434 patients are expected to be randomized into two treatment groups, receiving either ulotaront (SEP-363856, 50\u201375 mg\/day) or placebo in a 1:1 ratio for eight weeks. The primary endpoint is reduced anxiety symptoms, as measured by a change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score, compared to placebo at Week 8.<\/p>\n

\n\u201cWith the expansion of ulotaront\u2019s clinical development program to a third indication, we are making significant progress towards goals we set for co-development and co-commercialization with Sunovion to address areas of high unmet need for people living with serious mental illnesses,\u201d said John Kraus, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Otsuka. \u201cWe believe that ulotaront has the potential to help those living with GAD safely and effectively manage their symptoms and we look forward to advancing the understanding of this innovative compound.\u201d<\/p>\n

\nAbout Ulotaront (SEP-363856)<\/b><\/p>\n

\nUlotaront, a TAAR1 agonist with 5-HT1A<\/sub> agonist activity, is currently under investigation for the treatment of schizophrenia, generalized anxiety disorder (GAD) and the adjunctive treatment of major depressive disorder (MDD) with additional indications under consideration.<\/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 Phase 3 clinical studies in adults and adolescents (13 to 17 years) with schizophrenia. Ulotaront is also the first TAAR1 agonist to enter Phase 2\/3 clinical studies in GAD and the adjunctive treatment of MDD.<\/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.<\/p>\n

\nAbout Generalized Anxiety Disorder<\/b><\/p>\n

\nAn estimated 374 million people globally are impacted by anxiety disorders.3<\/sup> Generalized anxiety disorder (GAD) <\/strong>is a type of anxiety disorder characterized by excessive anxiety and worry about a variety of events or activities (e.g., work or school performance) that occurs more days than not, for at least six months.4<\/sup> People with GAD find it difficult to control their worry, feel restless or on edge, fatigued, have difficulty concentrating, feel irritable or have trouble falling or staying asleep.5<\/sup> GAD may cause impairment in social and occupational functioning, or other areas of daily life and may be brought on or exacerbated by stressful life events.5<\/sup> Roughly 20 million people in the U.S. will experience GAD at some point in their lifetime.6,7<\/sup><\/p>\n

\nAbout Sunovion Pharmaceuticals Inc. (Sunovion)<\/b><\/p>\n

\nSunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion has charted new paths to life-transforming treatments that reflect an ongoing commitment to research and development for people living with serious psychiatric and neurological conditions.<\/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<\/a> and www.sunovion.ca<\/a>. Connect with Sunovion on Twitter<\/a>, LinkedIn<\/a>, Facebook<\/a>, and YouTube<\/a>.<\/p>\n

\nAs announced on April 3, Sunovion will combine with affiliate companies Sumitomo Pharma America Holdings, Inc., Sumitovant Biopharma, Inc., Myovant Sciences, Inc., Urovant Sciences, Inc., Enzyvant Therapeutics, Inc., and Sumitomo Pharma Oncology, Inc. to form Sumitomo Pharma America, Inc. effective July 1, 2023.<\/p>\n

\nAbout Sumitomo Pharma Co., Ltd.<\/b><\/p>\n

\nSumitomo 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<\/a>.<\/p>\n

\nAbout Otsuka Pharmaceutical Co., Ltd. (Otsuka)<\/b><\/p>\n

\nOtsuka 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.<\/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. 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\u2019 1,700 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.<\/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 13.1 billion in 2022.<\/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> and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.\u2019s global website is accessible at www.otsuka.co.jp\/en\/<\/a>.<\/p>\n

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

\n\u00a9 2023 Sunovion Pharmaceuticals Inc. All rights reserved.<\/p>\n

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

\nReferences<\/b><\/p>\n

    \n
  1. \nKessler, RC., et al. Twelve\u2010month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012 Sep; 21(3): 169\u2013184. Published online 2012 Aug 1. doi: 10.1002\/mpr.1359<\/li>\n
  2. \nUS Census Bureau. U.S. Adult Population Grew Faster Than Nation\u2019s Total Population From 2010 to 2020. 2021. https:\/\/www.census.gov\/library\/stories\/2021\/08\/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html<\/a><\/li>\n
  3. \nCOVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet 2021; 398: 1700\u201312 https:\/\/doi.org\/10.1016\/S0140-6736(21)02143-7<\/a><\/li>\n
  4. \nNational Institute of Mental Health. General Anxiety Disorder. https:\/\/www.nimh.nih.gov\/health\/statistics\/generalized-anxiety-disorder<\/a><\/li>\n
  5. \nNational Institute of Mental Health. When Worry Gets Out of Control. https:\/\/www.nimh.nih.gov\/sites\/default\/files\/documents\/health\/publications\/generalized-anxiety-disorder-gad\/generalized_anxiety_disorder.pdf<\/a><\/li>\n
  6. \nSzuhany KL, Simon NM. Anxiety disorders: a review. JAMA<\/i>. 2022;328(24):2431-2445. doi:10.1001\/jama.2022.22744<\/a><\/li>\n
  7. \nUS Census Bureau. U.S. and World Population Clock. 2023. https:\/\/www.census.gov\/popclock\/<\/a><\/li>\n<\/ol>\n

    \n\u00a0<\/p>\n

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

    \nFor Sunovion<\/b>
    Kirsten Fallon
    \n
    Director, Product and Portfolio Communications
    \n
    Sunovion Pharmaceuticals Inc.
    \n
    774-369-7116
    \n
    kirsten.fallon@sunovion.com<\/a><\/p>\n

    \nFor Otsuka<\/b>
    Robert Murphy
    \n
    Senior Director, External Communications
    \n
    Otsuka America Pharmaceutical, Inc.
    \n
    609-249-7262
    \n
    robert.murphy@otsuka-us.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    \u2013Approximately 7.5 Million People in The U.S. Are Living with Generalized Anxiety Disorder (GAD) 1,2\u2013 MARLBOROUGH, Mass. & PRINCETON, N.J.–(BUSINESS WIRE)–#Sunovion—Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in a Phase 2\/3 clinical study evaluating ulotaront, a trace amine-associated receptor 1 (TAAR1) … [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-56237","6":"format-standard","7":"category-industry"},"yoast_head":"\nSunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety 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\/sunovion-and-otsuka-initiate-clinical-development-of-ulotaront-for-the-treatment-of-generalized-anxiety-disorder\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety Disorder - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"\u2013Approximately 7.5 Million People in The U.S. Are Living with Generalized Anxiety Disorder (GAD) 1,2\u2013 MARLBOROUGH, Mass. & PRINCETON, N.J.–(BUSINESS WIRE)–#Sunovion—Sunovion Pharmaceuticals Inc. 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(Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in a Phase 2\/3 clinical study evaluating ulotaront, a trace amine-associated receptor 1 (TAAR1) ... 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