New atypical antipsychotic approved

Abstract

The atypical antipsychotic drug iloperidone has been approved for the U.S. market, FDA and Vanda Pharmaceuticals announced in May. Iloperidone, a piperidinyl-benzisoxazole derivative, is indicated for the acute treatment of schizophrenia in adults and will be sold in the United States as Fanapt. “Vanda plans to make Fanapt available in pharmacies later this year,” said Mihael Polymeropoulos, the company’s chief executive officer, during a May 7 conference call. Fanapt is an α-adrenergic blocker that can cause orthostatic hypotension, according to the product’s FDA-approved labeling. To minimize this risk, the first-day treatment regimen should be 1 mg given twice, with the dosage gradually increased over several days. The recommended target dosage of iloperidone is 12–24 mg/day taken twice daily with or without a meal. The labeling states that because upward dosage adjustments are necessary to reach a therapeutic dosage, it may take one to two weeks before a patient’s symptoms are controlled by the drug. Any time a patient stops taking iloperidone for more than three days and wants to resume therapy, the gradual upward dosage-adjustment schedule should be repeated.