Otsuka and Lundbeck announced the submission of a New Drug Application (NDA) to the FDA for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).
The NDA submission is supported by seven completed Phase 2 and 3 clinical studies in the proposed indications. The clinical development program for brexpiprazole included more than 6,500 participants of whom more than 5,300 received brexpiprazole. The FDA will determine if the NDA is sufficiently complete to allow for a substantive review of the data; a decision on initiation of the substantive review is expected in September 2014.
Brexpiprazole, a novel investigational compound 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 5HT2A and noradrenaline alpha1B/2C receptors.