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11/18/2002

FDA Gives Nod to Aripiprazole as Schizophrenia Treatment

Kate Traynor

The Food and Drug Administration last Friday approved the marketing of Abilify, or aripiprazole, an antipsychotic product indicated for the treatment of schizophrenia.

Abilify will be jointly marketed in the United States by Bristol-Myers Squibb Co. and Otsuka America Pharmaceutical Inc. The companies have announced that they expect the product to be widely available in pharmacies by the end of the month.

According to the product's labeling, Abilify is formulated in 10-, 20-, or 30-mg tablets packaged in 30-count bottles or 100-count blister packs.

The recommended starting dosage is 10 or 15 mg of aripiprazole taken once per day with or without food.

Although aripiprazole's effective dosage range is described as 10–30 mg/day, the product's labeling notes that, in clinical trials, dosages above 15 mg/day were not more effective than 10 or 15 mg/day. The labeling recommends that the dosage not be increased during the first two weeks of therapy.

Because aripiprazole is metabolized by cytochrome P450 (CYP) isoenzymes 3A4 and 2D6, a dosage adjustment should be made when the medication is taken concurrently with a drug, such as ketoconazole carbamazepine, or fluoxetine, that potentially affects the activity of CYP3A4 or CYP2D6.

Adverse events associated with aripirprazole use during the clinical studies include headache, nausea, vomiting, sleep changes, and lightheadedness. Somnolence was the only adverse event that appeared to be dose-related and was associated with the 30-mg/day dosage.

During the clinical studies, two cases of neuroleptic malignant syndrome, a potentially fatal disease, occurred that may have been associated with use of the drug, according to the product's labeling. The labeling also warns that patients should be monitored for symptoms of tardive dyskinesia, a complication associated with the use of antipsychotic drugs.