Otsuka Pharmaceutical and H. Lundbeck A/S has received marketing authorization approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

According to the companies, Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia. It has a tolerability profile similar to oral aripiprazole and demonstrated statistically significant benefits on patients’ personal and social functioning as compared to placebo.

The efficacy of Abilify Maintena was demonstrated in two double-blind, Phase III, randomized trials. The safety profile for Abilify Maintena was demonstrated to be similar to that of oral Abilify. The most frequently observed adverse drug reactions (ADRs) reported in ≥5 percent of patients in two double-blind controlled clinical trials of Abilify Maintena were weight increases (9.0%), akathisia (7.9%), insomnia (5.8%), and injection site pain (5.1%).