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FDA Approves Once-Monthly Abilify (Aripiprazole) for Schizophrenia

Extended-release formulation administered via intramuscular injection (Mar. 1)

The FDA has approved Abilify Maintena (Otsuka/Lundbeck) — an extended-release depot formulation of aripiprazole — for once-monthly treatment of schizophrenia via intramuscular injection. Aripiprazole is a dopamine D2 partial agonist.

The efficacy of Abilify Maintena was demonstrated in a 52-week, phase III, placebo-controlled, double-blind, randomized-withdrawal, maintenance trial in adult patients with schizophrenia. Abilify Maintena (n = 269) significantly delayed the time to relapse — the study’s primary endpoint — compared with placebo (n =134) (hazard ratio = 5.03; P < 0.0001). In a key secondary endpoint, the percentage of subjects experiencing relapse (i.e., those meeting clinical trial criteria for exacerbation of psychotic symptoms/relapse) was also significantly lower in the Abilify Maintena group versus the placebo group at the end of the study (10% vs. 40%, respectively; P < 0.0001).

The results from this clinical trial were first presented at the 2012 American Psychiatric Association Annual Meeting in May 2012, and were later published in the Journal of Clinical Psychiatry.

Abilify Maintena (300 and 400 mg) has been evaluated for safety in 1,287 adult patients in clinical trials in schizophrenia, with approximately 1,281 patient-years of exposure to the drug. The safety profile of Abilify Maintena is expected to be similar to that of oral aripiprazole.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis.

Source: Otsuka; March 1, 2013.

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