FDA approves label update for Abilify Maintena for Schizophrenia-Otsuka/Lundbeck
The FDA has approved the labeling update of Abilify Maintena (aripiprazole), from Otsuka/Lundbeck, for extended-release injectable suspension in patients with Schizophrenia. The labeling update provides a description of controlled clinical study of Abilify Maintena for treating adult patients experiencing acute relapses of Schizophrenia. 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.
These data were published in the November print edition of The Journal of Clinical Psychiatry. See: "Aripiprazole Once-Monthly in the Acute Treatment of Schizophrenia: Findings From a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study." Kane J., et al. Journal of Clinical Psychiatry. 2014;75 (11): 1254–1260.
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