Jane S. Ricciuti, RPh, MS


October 21, 2003

In This Article

Antipsychotic Agents

(aripiprazole) Tablets

Manufacturer: Otsuka America Pharmaceutical, Inc.

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 8/28/03)

New Indication: The indication was expanded to include longer-term efficacy of Abilify (aripiprazole) in the treatment of schizophrenia.

The efficacy of aripiprazole in maintaining stability in patients with schizophrenia who had been symptomatically stable while taking other antipsychotic medications for periods of 3 months or longer, who had stopped taking those other medications, and who were then administered aripiprazole, 15 mg/d, and observed for relapse during a period of up to 26 weeks was demonstrated in a placebo-controlled trial. The physician who elects to use aripiprazole for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Clinical Summary: Aripiprazole was studied in 310 inpatients or outpatients meeting DSM-IV criteria for schizophrenia. In a 26-week, randomized, placebo-controlled trial of aripiprazole, 15 mg once daily, patients taking aripiprazole, 15 mg, experienced a significantly longer time to relapse during the subsequent 26 weeks compared with those patients receiving placebo.

Abilify (aripiprazole) Tablets Labeling

Abilify (aripiprazole) Tablets