FDA approves Saphris to treat schizophrenia and bipolar I

August 19, 2009

The U.S. Food and Drug Administration has approved Saphris tablets to treat adults with schizophrenia, and bipolar I disorder in adults.

The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia and bipolar I disorder in adults.

“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.”

Saphris belongs to a class of drugs known as atypical antipsychotics. All atypical antipsychotics contain a black box 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 (a brain disorder that lessens the ability to remember, think, and reason). Saphris is not approved for these patients.

The efficacy of Saphris in treating schizophrenia was studied in three short-term, placebo-controlled, and active-drug-controlled clinical trials, according to a statement from the FDA. In two of the trials, Saphris demonstrated superior efficacy compared to placebo (an inactive pill) in reducing the symptoms of schizophrenia.

The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were the inability to sit still or remain motionless (akathisia), decreased oral sensitivity (oral hypoesthesia), and drowsiness (somnolence).

The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term, placebo-controlled, and active-drug-controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder.

The most common adverse reactions reported by patients in clinical trials using Saphris to treat bipolar disorder were drowsiness, dizziness, movement disorders other than akathisia, and weight increase.

Saphris is manufactured by Schering-Plough, Kenilworth, N.J.