July 14, 2014
The clinical development program for brexpiprazole included more than 6,500 participants of whom more than 5,300 received brexpiprazole. The NDA is supported by seven completed Phase 2 or 3 clinical studies in the proposed indications. Following the submission the U.S. Food & Drug Administration (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 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.