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Avanir business is now integrated into Otsuka America Pharmaceutical, Inc. and www.avanir.com is no longer an active website.

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December 2022    01US22EUC0239

US News

Otsuka Pharmaceutical to Acquire Jnana Therapeutics Inc.

Otsuka Pharmaceutical Co., Ltd. and Jnana Therapeutics Inc. announced that they have entered into a definitive merger agreement pursuant to which Otsuka will acquire Jnana, making it a wholly owned subsidiary through Otsuka's 100-percent owned subsidiary, Otsuka America, Inc. (OAI). The acquisition is expected to be completed in the third quarter of fiscal 2024, subject to customary closing conditions.

August 01, 2024

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Press Release

Otsuka and Lundbeck Present New REXULTI® (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2024

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck Pharmaceuticals LLC presented new post hoc pooled analyses of Phase 3 trials evaluating the safety and efficacy of REXULTI® (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer’s disease. These data analyses were presented in three posters at the 2024 Alzheimer’s Association International Conference (AAIC), taking place July 28 to Aug. 2 in Philadelphia, USA.

July 31, 2024

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Press Release

Otsuka and Lundbeck Announce FDA Acceptance of sNDA Filing for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)

Otsuka Pharmaceutical, Co. Ltd. and H. Lundbeck A/S announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

June 25, 2024

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Press Release

Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck Pharmaceuticals LLC 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. The findings were presented at the American Society of Clinical Psychopharmacology Annual Meeting in Miami.

May 28, 2024

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Press Release

Otsuka to Terminate Development of AVP-786

Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. announce termination of development of the novel compound AVP-786, which was in development as a potential treatment for patients with agitation associated with dementia due to Alzheimer's disease. 

May 22, 2024

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Press Release

Meharry School of Global Health Releases Landmark Report Showing Mental Health Inequities in the U.S. Could Cost an Estimated $14 Trillion by 2040

The School of Global Health at Meharry Medical College (Meharry) with support from Otsuka America Pharmaceutical, Inc., today released The Projected Costs and Economic Impact of Mental Health Inequities in the United States report. Findings show, that if not addressed, mental health inequities combined with expenditures related to chronic conditions, could cost the U.S. economy an estimated $14 trillion between now and 2040.

May 15, 2024

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Press Release

Otsuka Becomes Lead Founding Sponsor of PBS and WETA’s New Caregiving Documentary, Executive Produced by Bradley Cooper

Otsuka America Pharmaceutical, Inc., announces that the company is the lead, founding sponsor of Caregiving, a two-hour documentary dedicated to portraying the challenges and triumphs of caregivers through their personal stories. The project, executive produced by Bradley Cooper, is slated for release in Spring 2025 and is the next feature film of WETA’s award-winning Well Beings campaign that addresses critical health needs in America.

May 08, 2024

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Press Release

Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults.

April 10, 2024

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Press Release

Otsuka Works with Verily to Launch Longitudinal Mental Health Registry to Advance Novel Research in Psychiatry

Otsuka Pharmaceutical Development & Commercialization, Inc. announces the launch of My Mental Health Journey, a longitudinal registry study that aims to advance research in depression and mental health. Verily Life Sciences LLC (Verily), a precision health technology company, will recruit participants and run the study. 

April 04, 2024

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Press Release

Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms

Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the U.S. Food and Drug Administration  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. Rejoyn is intended to reduce MDD symptoms.

April 01, 2024

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