Lundbeck and Otsuka announced that the Food and Drug Administration (FDA) has approved the labeling update for Abilify Maintena (aripiprazole) for extended-release injectable suspension.

The expanded approval was based on results from a 12-week randomized, double-blind, placebo-controlled study in adults with acute relapsed schizophrenia (n=339). The primary efficacy endpoint was the change from baseline to Week 10 of treatment in PANSS total score. Study results showed that treatment with Abilify Maintena (concomitant oral aripiprazole for the first two weeks) led to a greater improvement vs. placebo (-6.8 vs. -11.7 P<0.0001). Also, statistically significant improvements with Abilify Maintena were seen at all time points measured from Week 1–12.

RELATED: Results from First-of-Kind Abilify Maintena Study Announced

Abilify Maintena, an atypical antipsychotic, is already approved for use in the treatment of schizophrenia. The mechanism of action of aripiprazole in the treatment of schizophrenia is unknown. However, the efficacy may be mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors.

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