Otsuka Pharmaceutical and H. Lundbeck A/S announced that the U.S. Food and Drug Administration (FDA) approved the labeling update of Abilify Maintena® (aripiprazole) for extended-release injectable suspension. The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia. Efficacy was demonstrated in a 12-week randomized, double-blind, placebo-controlled study, which showed treatment with Abilify Maintena (with concomitant oral aripiprazole for the first two weeks) significantly improved symptoms with an acceptable safety and tolerability profile in adult patients experiencing an acute relapse of schizophrenia. 1 These data were published in the November print edition of TheJournal of Clinical Psychiatry.
Abilify Maintena, an atypical antipsychotic, was first approved by the FDA in February 2013 for intramuscular (gluteal) use for the treatment of schizophrenia. Efficacy was demonstrated in a placebo-controlled, randomized withdrawal maintenance trial in adult patients with schizophrenia, and additional support for efficacy was derived from oral aripiprazole trials.
“An acute exacerbation of psychotic symptoms, also referred to as disease relapse, is a key consideration in the management of schizophrenia, and can occur when a patient no longer responds to or stops taking antipsychotic medication,” said study investigator John M. Kane, M.D., Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. “These data – and the updated product labeling – confirm the utility of Abilify Maintena in acutely relapsed adult patients, giving physicians an option to consider for both the initial and ongoing treatment of patients with schizophrenia.”