FDA marks Abilify sNDA for priority review

US drug major Bristol-Myers Squibb and Japanese strategic partner Otsuka Pharmaceuticals say that the US Food and Drug Administration has accepted a supplemental New Drug Application seeking clearance for the co-developed atypical antipsychotic Abilify (aripiprazole) as an adjunctive treatment for adults with major depressive disorder.

Abilify is the first and only available dopamine agonist It is thought to mediate its therapeutic antipsychotic effects through its interaction with the D2 receptor. The drug, in common with other currently-available atypical antipsycotic agents, is also a partial agonist for the 5-HT1A receptor.

The sNDA is based on data from two six-week randomized, double-blind, placebo-controlled assessments of Abilify in MDD patients who have not adequately responded to antidepressant therapy. It is currently approved for the treatment of indications including acute, manic and mixed episodes of bipolar I disorder and schizophrenia, and has been designated for priority review by the FDA, which could be completed in as little as six months.