The FDA has Approved Saphris to Treat Schizophrenia and Bipolar Disorder

The FDA today Approved Saphris (asenapine) to Treat Schizophrenia and Bipolar Disorder. Schizophrenia and Bipolar disorder are two disabling psychiatric disorders which affects millions of people around the world.

Here’s a statement from the FDA website: 

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 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).  

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.

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