Otsuka and Lundbeck announced that the FDA has approved Abilify Maintena (aripiprazole) for extended-release injectable suspension.  Abilify Maintena, a dopamine D2 partial agonist, is a once-monthly intramuscular depot injection indicated for the treatment of schizophrenia.

Efficacy was demonstrated in a Phase 3, placebo-controlled, double-blind, randomized-withdrawal, 52-week, maintenance trial of Abilify Maintena in patients with schizophrenia. The primary endpoint was the time to relapse. Results showed that Abilify Maintena (n=269 adult patients) significantly delayed time to relapse compared to placebo (n=134 adult patients; hazard ratio=5.03, 95% CI=3.15–8.02, p<0.0001).

Aripiprazole is currently approved and marketed as Abilify, Abilify Discmelt, Abilify Injection, and Abilify Oral Solution under BMS/Otsuka Partnership.

Abilify Maintena will be available in 300mg and 400mg strength vials of lyophilized powder for reconstitution. The product is expected to launch on March 18, 2013.

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