You are here

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 P

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.

Recent Headlines

Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
So far in January, the increases average 5%
Fast-acting insulin aspart may simplify mealtime dosing
Simple change in dosage and route may improve a century-old vaccine
Neurodevelopmental deficits detected in Colombian toddlers