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FDA Approves Saphris

The US FDA has approved Saphris to treat both adults with schizophrenia and adults with bipolar I disorder

The US Food and Drug Administration (FDA) has approved Saphris to treat both adults with schizophrenia and adults with bipolar I disorder.

The atypical antipsychotic drug Saphris (asenapine), manufactured by Schering-Plough, has been approved by the FDA for the treatment of adults with schizophrenia and adults with bipolar I disorder. The drug, however, is not approved for older people with dementia-related psychosis and, like all atypical antipsychotics, Saphris will contain a boxed warning (the FDA's strongest warning) alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioural problems in such patients.

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

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 a placebo in treating symptoms of bipolar disorder.

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), while patients given Saphris in clinical trials to treat bipolar disorder reported drowsiness, dizziness, movement disorders other than akathisia and weight increase.

"Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy," said Dr Thomas Laughren, 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."

17th August 2009


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