Posted by Michael Wonder on 06 Nov 2017
Health Canada approves Otsuka and Lundbeck's Abilify Maintena (aripiprazole once Monthly) as treatment for bipolar I disorder in adults
2 November 2017 - Otsuka Canada and Lundbeck Canada announce that Health Canada issued a Notice of Compliance for Abilify Maintena (aripiprazole for prolonged release injectable suspension), approving a new indication for the maintenance monotherapy treatment of bipolar I disorder in adult patients.
Abilify Maintena is a once-monthly injectable formulation for intramuscular use created by Otsuka and co-developed and co-commercialized with Lundbeck. In a placebo-controlled phase 3 trial, Abilify Maintena significantly reduced the risk of recurrence of any mood episode over 52 weeks compared to placebo.
