FDA reverses course, approves iloperidone.
The drug, which will sold by Rockville, Md.-based Vanda Pharmaceuticals, had been rejected by the FDA in July 2008. In a press release announcing the approval, the agency gave no hint of why it had reversed course.
But in a conference call with investors on May 7, Vanda CEO Mihael H. Polymeropoulos said that the agency was "open-minded to good scientific argument," and that the company had convinced the FDA that iloperidone was not inferior to other atypical antipsychotics.
Iloperidone, a mixed dopamine [D.sub.2]/ serotonin 5-[HT.sub.2]A-receptor antagonist, was approved on the basis of results from two placebo-controlled studies.
Dr. Polymeropoulos said iloperidone presents a unique safety profile, compared with other atypical antipsychotics. In studies, the overall mean weight increase was 2.1 kg. And the company said there were no medically important elevations in glucose, triglycerides, or cholesterol. Most importantly, iloperidone had a low incidence of extrapyramidal symptoms, Dr. Polymeropoulos said. Patients can be titrated up to a target starting dose of 12 mg in 4 days.
"This is probably one of the most compelling labels of all atypical antipsychotics," Dr. Polymeropoulos said.
In a 4-week, double-blind study of 593 psychiatric inpatients reported in a poster session last year at the annual American Psychiatric Association meeting, Dr. Peter J. Weiden and his colleagues found iloperidone to be just as effective as ziprasidone (Geodon) for the short-term treatment of acute schizophrenia.
The iloperidone patients also showed far greater improvement than those taking placebo in Positive and Negative Syndrome Scale-Total (PANSS-T) scores, as did those taking ziprasidone, according to Dr. Weiden, professor of psychiatry and director of the psychotic disorders program at the University of Illinois at Chicago.
Like other drugs in the class, iloperidone has the potential to affect the QTc interval. Similarly, it also will be required to carry a boxed warning on the increased risk of death associated with off-label use to treat behavioral problems with dementia-related psychosis, the FDA said.
The drug is not approved for patients with dementia-related psychosis.
Schizophrenia affects about 1% of American adults each year. Atypical antipsychotics are among the top-selling classes of drugs, with sales last year of $15 billion in the United States and $20 billion worldwide, Dr. Polymeropoulos said.
The drug will be manufactured by Patheon Inc. of Mississauga, Ont., and will available in pharmacies later this year, according to Vanda.
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|Publication:||Clinical Psychiatry News|
|Date:||Jun 1, 2009|
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