Saphris Gets FDA Approval to Treat Schizophrenia and Bipolar Disorder

The Food and Drug Administration has approved Saprhis, a drug known generically as asenapine, to treat adults with schizophrenia and bipolar disorder, two devastating psychiatric conditions that affect hundreds of thousands of Americans.

The drug, made by New Jersey-based Schering-Plough, belongs to a class of drugs called atypical antipsychotics. All drugs in the class carry “Black Box” warnings about the increased risks of death in patients with dementia-related psychosis who are treated with the drugs. While the class of drugs is not FDA approved to treat patients with the brain disorder that reduces the ability to think, reason, and remember, many doctors prescribe the drug to such patients “off label.”

Schizophrenia is a severe, chronic brain disorder that causes sufferers to hear voices, develop paranoia, and exhibit violent and unpredictable behavior. People with bipolar disorder commonly suffer from alternating periods of high activity and depression. The condition also is marked by increased activity and restlessness, racing thoughts, impulsive behavior, fast talking, and a decreased need for sleep.

The FDA said the approval of Saphris to treat the two devastating disorders will give physicians and patients another effective treatment option.

“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., 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.”

Clinical trials of Saphris have shown the drug reduces the symptoms of schizophrenia and bipolar disorder when compared to inactive placebo pills.

Side effects seen in people given the drug in the clinical trials for schizophrenia included an inability to remain motionless or sit still (also called akathisia), reduced oral sensitivity (oral hypoesthesia), and drowsiness.

In the bipolar disorder clinical trials, the most common adverse reactions reported were drowsiness, dizziness, movement disorders other than akathisia and weight increase, the FDA said.

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