FDA approves Abilify Maintena as a treatment for Schizophrenia

H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. have announced that the FDA has on 28 February 2013 approved Abilify Maintena (aripiprazole) for extended release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of Schizophrenia.

Abilify Maintena is the first dopamine D2 partial agonist approved as a once-monthly injection. It contributes a new treatment option to address the on-going need for relapse prevention in patients with Schizophrenia, a chronic, debilitating disease.

Efficacy was demonstrated in a 52-week, placebo-controlled, double-blind, randomised-withdrawal, phase III maintenance trial of Abilify Maintena in patients with Schizophrenia. The time to relapse was the primary endpoint. In the trial, 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)1. in a key secondary endpoint, the percentage of subjects experiencing relapse (i.e., meeting clinical trial criteria for exacerbation of psychotic symptoms relapse) was also significantly lower with abilify maintena compared to placebo at the end of the study (10% vs. 40%).>