FDA extends label of Abilify Maintena (aripiprazole) in schizophrenia- Otsuka

The FDA has expanded the label of Abilify Maintena (aripiprazole), from Otsuka, for extended-release injectable suspension to include a new injection site, the deltoid muscle of the arm. Healthcare providers will now have the option for either a gluteal or deltoid injection site for administering Abilify Maintena to patients with schizophrenia.

The approval of the deltoid injection site was based on two studies that evaluated the safety and tolerability and pharmacokinetics of Abilify Maintena administered in the deltoid muscle compared to the gluteal muscle in adult patients with schizophrenia.

Comment: Abilify Maintena is the only once-monthly injection of a dopamine D2 partial agonist (the first injection is accompanied by 14 days of oral antipsychotic therapy) approved for the treatment of adults with schizophrenia. It was originally indicated for only gluteal injection when approved by the FDA in February 2013.