News & Media

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck Pharmaceuticals LLC announce the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for the treatment of agitation associated with Alzheimer’s dementia (AAD). The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with REXULTI outweigh its risks.

Otsuka Pharmaceutical Co., Ltd and H. Lundbeck A/S published results from research demonstrating that an investigational long-acting injectable, aripiprazole 2-month, ready-to-use 960 mg, offers comparable tolerability, safety and therapeutic plasma levels as aripiprazole 1-month, ready-to-use 400 mg, currently approved in adult patients for the treatment of schizophrenia or the maintenance treatment of bipolar I disorder (BP-I). The research is published in CNS Drugs.

Otsuka Pharmaceutical Development & Commercialization, Inc.  and Verily, an Alphabet precision health company announced their expanded work together on innovative approaches to clinical trials studying treatments for adults with Major Depressive Disorder (MDD). 

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce the U.S. Food and Drug Administration has determined that the supplemental New Drug Application for brexpiprazole for use in the treatment of agitation associated with Alzheimer’s dementia is sufficiently complete to permit a substantive review.