WASHINGTON, May 7 -- The FDA has cleared the long-delayed antipsychotic drug iloperidone (Fanapt) for marketing as therapy for adult schizophrenia.
Iloperidone is a mixed dopamine D2/serotonin 5-HT2A receptor antagonist and is a member of the atypical antipsychotic drug class.
The agent had been dropped from development a decade ago after initial clinical trial results indicated it was less effective than other schizophrenia medications including risperidone (Risperdal) and haloperidol (Haldol).
Rights to the drug were sold to Vanda Pharmaceuticals, which conducted new trials including ziprasidone (Geodon) as the active comparator.
In the pivotal 593-patient, four-week trial leading to the new approval, iloperidone matched ziprasidone in improving scores on the Positive and Negative Syndrome Scale (PANSS) and both drugs were significantly better than placebo. (See APA: Sidelined Schizophrenia Drug Makes a Comeback)
Iloperidone also demonstrated efficacy in a separate placebo-controlled trial that lasted six weeks.
The recommended target dose range is 12 to 24 mg/day.
The most common adverse reactions in iloperidone's clinical trials were dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, drowsiness, tachycardia, and weight increase.
As with other atypical antipsychotics, iloperidone may affect the cardiac QTc interval, so physicians may consider prescribing iloperidone after other antipsychotics are tried first, according to the company.
Iloperidone will not be commercially available until later this year.