Labeling update of Lundbeck and Otsuka's Abilify Maintena approved by FDA

The US Food and Drug Administration approved the labeling update of Abilify Maintena (aripiprazole) for extended-release injectable suspension. The drug is marketed by Danish CNS drug specialist Lundbeck (LUN: CO) and Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768).

The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia. Efficacy was demonstrated in a 12-week randomized, double-blind placebo-controlled study, which showed treatment with Abilify Maintena (with concomitant oral aripiprazole for the first two weeks) significantly improved symptoms with an acceptable safety and tolerability profile in adult patients experiencing an acute relapse of schizophrenia with an acceptable safety and tolerability profile. These data were published in the November print edition of The Journal of Clinical Psychiatry .

Abilify Maintena, an atypical antipsychotic, was first approved by the FDA in February 2013 for intra-muscular (gluteal) use for the treatment of schizophrenia. Efficacy was demonstrated in a placebo-controlled, randomized withdrawal maintenance trial in adult patients with schizophrenia, and additional support for efficacy was derived from oral aripiprazole trials.