Lundbeck and Otsuka file for US approval of brexpiprazole

Danish CNS drug specialist Lundbeck (LUND: CO) and Japanese drugmaker Otsuka (TYO: 4768) have submitted a New Drug Application to the US Food and Drug Administration for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD), the companies revealed this morning.

The clinical development program included data from more than 6,500 participants of whom more than 5,300 received brexpiprazole. Following the filing the FDA will determine if the NDA is sufficiently complete to allow for a substantive review of the data; a decision from the FDA on initiation of the substantive review is expected in September 2014.

Brexpiprazole is a novel investigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.