Japan-based Otsuka Pharmaceutical and Danish pharmaceutical firm Lundbeck have submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for brexpiprazole to treat schizophrenia as well as an adjunctive treatment of major depressive disorder (MDD).
Discovered by Otsuka, the new investigational psychotropic compound brexpiprazole is being co-developed with Lundbeck.
The NDA for brexpiprazole is supported by seven completed clinical Phase II or III studies in proposed indications.
The clinical development program included over 6,500 individuals, including more than 5,300 who received brexpiprazole.
The FDA will now determine if the NDA is sufficiently complete to allow for a substantive review of the data and a decision from the FDA on initiation of the substantive review is expected in September 2014.
The companies said that 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.