Maryland-based Vanda Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Fanapt (otherwise known as iloperidone) for the acute treatment of adult schizophrenia patients. Fierce Biotech reports that the decision was supported by two short-term Phase III studies and safety data from over 3,000 patients. The FDA denied Vanda’s initial application last year, asking for more information.
Fanapt belongs to the class of drugs known as atypical antipsychotics, which includes medications such as Risperdal and Zyprexa. Vanda conducted two placebo-controlled studies (one lasting four weeks, the other lasting six weeks) involving adult patients who met the DSM-III/IV criteria for schizophrenia. Fanapt was found to be more effective than a placebo in controlling symptoms. The drug was also well-tolerated by patients. Observed side effects were dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and mild weight gain. Vanda is positioning Fanapt as a safe alternative to other antipsychotic drugs, which have been linked to significant weight gain and diabetes. Researchers found no “medically important” link between Fanapt and blood sugar.
Following the announcement, market shares in Vanda soared from $1.08 to $9.98 in extended Nasdaq trading.
The U.S. market for antipsychotic drugs is $15.8 billion. Other companies developing schizophrenia medications include Otsuka America Pharmaceutical, Addex Pharmaceuticals, Janssen Pharmaceutica Products, Neuro3d, Prestwick Pharmaceuticals, Titan Pharmaceuticals, and Memory Pharmaceuticals (now a wholly owned subsidiary of Roche).