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.
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.
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.
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.
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.
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.
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.
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.
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.
Otsuka announces that interim data from a Phase 2b/c trial exploring quabodepistat (QBS), in combination with delamanid and bedaquiline, for the treatment of pulmonary tuberculosis (TB) is positive and may shorten the duration of TB treatment for patients. QBS is an investigational anti-tuberculosis compound which has a new mechanism of action that interferes with the cell-wall structure of the bacteria causing TB.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck U.S., the U.S. subsidiaries of H. Lundbeck A/S, presented new post hoc pooled analyses of two pivotal Phase 3 trials evaluating the safety and efficacy of REXULTI® (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer’s disease.1 The posters were presented on March 16 at the American Association for Geriatric Psychiatry (AAGP) 2024 Annual Meeting in Atlanta.
Otsuka Pharmaceutical Co., Ltd. announces the revision of the license agreement signed in September 2021 with Sumitomo Pharma Co., Ltd. and its U.S. subsidiary, Sumitomo Pharma America, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc., Otsuka Pharmaceutical, Co. Ltd., and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN; Berger’s disease).
Otsuka Pharmaceutical Development & Commercialization, Inc., and our parent company Otsuka Pharmaceutical, Co. Ltd. announce topline results of the phase 3 clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease (Trial 17-AVP-786-305; NCT03393520).
Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck Pharmaceuticals LLC announce that treatment with REXULTI® (brexpiprazole) resulted in statistically significant and clinically meaningful improvements in adult patients with agitation associated with dementia due to Alzheimer’s disease, according to the complete results of the placebo-controlled pivotal phase 3 Study 213 (NCT03548584), published today in JAMA Neurology.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Visterra Inc., today announced that the full results of a Phase 2 trial of sibeprenlimab (VIS649) for treatment of immunoglobulin A nephropathy (IgAN; Berger’s disease) have been published in the New England Journal of Medicine.1 The topline findings will also be presented in a late-breaking poster session at the American Society of Nephrology (ASN) Kidney Week meeting in Philadelphia, PA.
Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc., announced positive results of two, 6-week, Phase 3 clinical trials that evaluated the efficacy, safety, and tolerability of centanafadine for the treatment of adolescents and children with attention-deficit/hyperactivity disorder (ADHD). Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor.