FDA APPROVES FANAPT TO TREAT SCHIZOPHRENIIA

FDA NEWS
FOR IMMEDIATE RELEASE
May 6, 2009
FDA APPROVES FANAPT TO TREAT SCHIZOPHRENIA
The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schozophrenia, 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.”
Fanapt is included in the atypical antipsychotic class of drugs. All atypical antipsychotic contain a boxed warning, the FDA's strongest warning.
The learning alerts prescribers to an increase chance of death associated with off-label use of these drugs to treat behavioral behavior 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 report 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), drowiness, rapid heart rate (tachycardia) and weight increase.
Fanapt is manufactured by Patheon Inc. of Mississauga, Ontario for Vanda Pharmaceuticals Inc., Rockville, MD.