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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
May 6, 2009

Media Inquiries:
Sandy Walsh, 301-796-4669
Consumer Inquiries:
888-INFO-FDA


FDA Approves Fanapt to Treat Schizophrenia

The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder.

"Schizophrenia can be a devastating illness requiring lifelong treatment and therapy," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Medications for schizophrenia can ease many symptoms, allowing people to live more independent lives."

Schizophrenia affects about 1 percent of the U.S. adult population, ages 18 and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behavior, and abnormal expression of emotions. Hearing voices that other people don't hear is the most common type of hallucination. These experiences can make people with the disorder fearful and withdrawn.

Fanapt is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning, the FDA's strongest warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. Fanapt is not approved for patients with dementia-related psychosis.

Fanapt demonstrated efficacy in two placebo-controlled short-term clinical trials. In both, Fanapt was superior to placebo (sugar pill) in reducing the symptoms of schizophrenia.

The most common adverse reactions reported by patients using Fanapt in clinical trials were dizziness, dry mouth, fatigue, nasal congestion, sudden fall in blood pressure causing light-headedness upon standing (orthostatic hypotension), drowsiness, rapid heart rate (tachycardia) and weight increase.

Fanapt is manufactured by Patheon Inc. of Mississauga, Ontario, for Vanda Pharmaceuticals Inc., Rockville, Md.

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