Saphris  (asenapine) sublingual tablets
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Indications

Saphris tablets (asenapine) was approved to treat adults with schizophrenia and
bipolar I disorder on Aug. 14, 2009.

Efficacy (Schizophrenia)
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.

Efficacy (Bipolar Disorder)
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.

Common Side Effects (Patients with 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).  

Common Side Effects (Patients with 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.

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

SOURCE FDA NEWS RELEASE, FDA Approves Saphris to Treat Schizophrenia
and Bipolar Disorder, Aug. 14, 2009