FDA to Review sNDA for Abilify Maintena
Otsuka and Lundbeck announced that the FDA has accepted for review a supplemental New Drug Application (sNDA) for Abilify Maintena (aripiprazole extended-release injectable suspension) to broaden the indication for treatment of patients in the acute phase of schizophrenia.
The sNDA submission was based on positive results from a 12-week study of hospitalized patients with schizophrenia experiencing an acute exacerbation of symptoms. The primary endpoint was Positive and Negative Syndrome Score (PANSS) total score, and the key secondary endpoint was Clinical Global Impression – Severity (CGI-S) score. Abilify Maintena demonstrated efficacy in both the primary and secondary endpoints (p<0.0001).
Abilify Maintena, a dopamine D2 partial agonist, is a once-monthly intramuscular depot injection already approved for the treatment of schizophrenia.