Otsuka, Lundbeck announce availability of Abilify Maintena in Canada

Abilify Maintena is the first product in Canada from the global alliance between Otsuka and Lundbeck, which is focused on developing central nervous system (CNS) therapies worldwide.

Abilify Maintena is indicated for the maintenance treatment of schizophrenia in stabilized adult patients. Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia.

In controlled clinical trials, Abilify Maintena was found to prevent relapse for up to 38 weeks after stabilization with oral aripiprazole, and has a tolerability profile similar to oral aripiprazole.

Efficacy was demonstrated through two pivotal trials: a 38-week double-blind randomized non-inferiority trial to examine the proportion of subjects meeting impending relapse criteria compared to oral aripiprazole, and a 52-week placebo-controlled trial, which examined the time to impending relapse.

The latter study was terminated early after demonstrating that time to impending relapse was significantly delayed with Abilify Maintena compared with placebo injection (p < 0.0001; log rank test) at the pre-planned interim analysis.