FDA Approves Saphris Tablets

The FDA has approved Saphris tablets (asenapine) to treat adults with schizophrenia and bipolar I disorder.

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 efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia.

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

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