FDA approves Abilify Maintena (aripiprazole) for monotherapy treatment of bipolar I disorder- Lundbeck and Otsuka

Lundbeck and Otsuka Pharmaceutical Co announced Abilify Maintena (aripiprazole) for extended-release injectable suspension was approved by the FDA for the maintenance monotherapy treatment of bipolar I disorder (BP I) in adults. Based on phase III study data, Abilify Maintena delayed the time to recurrence of any mood episode in adult patients experiencing a manic episode at screening compared to placebo.

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: hospitalization and/or treatment with a mood stabilizer, and/or treatment with an antipsychotic agent. The primary endpoint demonstrated Abilify Maintena significantly delayed time to recurrence of any mood episode during a 52-week treatment study compared with placebo. 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.

Comment: Abilify Maintena is a once-monthly injectable formulation for intramuscular use created by Otsuka and has been co-developed and co-commercialized with Lundbeck.