FDA Approves Once-Monthly Treatment for Schizophrenia

The US Food and Drug Administration (FDA) has approved long-acting aripiprazole (Abilify Maintena, Otsuka/Lundbeck) for the maintenance treatment of adults with schizophrenia.

A once-monthly intramuscular (IM) depot formulation, the drug has the same efficacy and safety profile as the oral formulation, the manufacturers report. The FDA approval follows positive results of a phase 3 double-blind, placebo-controlled trial.

First presented at the American Psychiatric Association 2012 Annual Meeting and reported by Medscape Medical News at that time, the study demonstrated that adult outpatients who received the once-monthly IM injections had a significantly greater delay in time to relapse and a significantly lower rate of relapse compared with their counterparts who received placebo.

by Caroline Cassels, Medscape

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  1. That’s great news. Seems like this is a step in the right direction towards finding a cure for schizophrenia.

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