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.
For more information call (866) 337-6996 or visit www.lundbeckus.com