Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. 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-HT_1A 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).

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.

Otsuka America Pharmaceutical, Inc., and Lundbeck US presented positive efficacy and safety data from multiple Phase 3 studies of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia at the Clinical Trials for Alzheimer’s Disease (CTAD) Congress in San Francisco, CA.

Otsuka Pharmaceutical Development & Commercialization, Inc. and Sunovion Pharmaceuticals Inc. announced that the first patient has been enrolled in a Phase 2/3 clinical study to evaluate ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT_1A agonist activity, as an adjunctive therapy in the treatment of adults living with major depressive disorder.

Otsuka America Pharmaceutical, Inc. announces that it will integrate Avanir Pharmaceuticals into its business as of January 1, 2023. The move brings together the knowledge, capabilities and best practices of both companies to further advance solutions to treat central nervous system disorders.