28 July 2017 - New indication for Abilify Maintena is based on studies evaluating efficacy and safety in adult patients with bipolar I disorder.

Lundbeck and Otsuka today announced Abilify Maintena (aripiprazole) for extended-release injectable suspension was approved by the U.S. FDA for the maintenance monotherapy treatment of bipolar I disorder (BP I) in adults.

The phase III clinical trial supporting regulatory approval demonstrated the efficacy and safety of Abilify Maintena in the maintenance monotherapy treatment of BP-I. The study included patients who were experiencing a manic episode at trial entry and met DSM-IV-TR criteria for bipolar I disorder. In addition, patients had a history of at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalisation and/or treatment with a mood stabiliser, and/or treatment with an antipsychotic agent. The clinical trial was a 52-week, double-blind, placebo-controlled, randomized withdrawal trial in adults with BP-I aged 18 to 65 years, who were stabilised with Abilify Maintena prior to randomisation. The primary endpoint demonstrated Abilify Maintena significantly delayed time to recurrence of any mood episode during a 52-week treatment study compared with placebo1. The trial demonstrated significant differences between treatment groups in delaying time to recurrence of both manic and mixed episodes but no substantial difference in depressive mood episodes.

Read Lundbeck press release