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Featured news

07/31
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
Neuroscience

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.

06/25
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)
Neuroscience

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.

05/28
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
Neuroscience

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.