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Psychotropic Drug Brexpiprazole Submitted to FDA
A new drug application (NDA) has been submitted to the FDA for the investigational psychotropic compound brexpiprazole (Otsuka/Lundbeck) for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).
The NDA was supported by seven completed clinical phase II or III studies in proposed indications.
The drug’s clinical development program included data from more than 6,500 participants, of whom more than 5,300 received brexpiprazole. After the submission, the FDA will determine whether the NDA is sufficiently complete to allow a substantive review of the data; a decision from the FDA on the initiation of their review is expected in September 2014.
Brexpiprazole is a serotonin–dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potencies, and as an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.
Phase III trial data on the effect of brexpiprazole as adjunctive therapy to antidepressant therapy in patients with MDD were presented March 2 at the 22nd European Psychiatry Association Congress in Munich, Germany. Key findings included the following:
- Statistically significant improvements in the mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score were observed in patients receiving adjunctive brexpiprazole compared with placebo.
- Brexpiprazole provided a statistically significant advantage over placebo on all secondary endpoints.
- The most common adverse events reported in patients receiving adjunctive brexpiprazole included weight gain and akathisia.
- More than 90% of the patients completed the randomized phase of the trial.