WASHINGTON — The FDA approved the atypical antipsychotic asenapine (Saphris) for schizophrenia and bipolar disorder in adults, making it the first psychotropic drug to gain initial approval for both conditions.

The drug is indicated for first-line use in acute treatment of schizophrenia and of manic or mixed episodes in bipolar I disorder, with or without psychotic features.

FDA approval was based on data from more than 3,000 patients showing statistically significant efficacy versus placebo in acute schizophrenia trials and statistically significant reduction of bipolar mania symptoms versus placebo.

The drug showed signs of treating negative schizophrenia symptoms better than risperidone (Risperdal) in early clinical trials, but the advantage was not subsequently confirmed against olanzapine (Zyprexa, Zydis). (See APA: New Drug No Better for Negative Schizophrenia Symptoms)

Like other atypical antipsychotics, asenapine’s side effects include sedation, weight gain, tardive dyskinesia, and diabetes risks. However, a clinical trial showed that asenapine’s rate of weight gain was significantly lower than that experienced with olanzapine, a similar antipsychotic.

Atypical antipsychotics also show an increased likelihood of death in elderly patients treated for dementia-related psychosis.

The tablets are available in five and 10 mg doses and should be taken twice daily.

Manufacturer Schering-Plough said it plans to make the drug available in the fourth quarter of 2009.

Related Article(s):

• APA: New Drug No Better for Negative Schizophrenia Symptoms

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