Magazine article Clinical Psychiatry News

Asenapine Wins Approval Based on Short-Term Data: Sublingual Antipsychotic Adds to Options

Magazine article Clinical Psychiatry News

Asenapine Wins Approval Based on Short-Term Data: Sublingual Antipsychotic Adds to Options

Article excerpt

The approval of asenapine, a sublingual formulation of atypical antipsychotic for treating bipolar I disorder and schizophrenia in adults, is a welcome development for the ongoing need for additional treatment options for these populations, said Dr. Dost Ongur of McLean Hospital, Belmont, Mass.

"Physicians typically try one medication and then another until they can find a medication that is tolerated by the patient and leads to an improvement in the patient's condition," Dr. Ongur, medical director of the schizophrenia and bipolar program at the hospital, said in an interview. "Having an additional choice is useful in this regard."

The indications approved by Food and Drug Administration are the acute treatment of schizophrenia in adults, and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

The Schering-Plough Corp. will market asenapine under the trade name Saphris, which will be available in the United States during the fourth quarter of 2009, according to the company.

For the schizophrenia indication, the approved dose is 5 mg sublingually twice a day; for the bipolar indication, the approved starring dose is 10 mg twice daily--which can be decreased to 5 mg twice a day if the patient develops adverse effects.

According to Dr. Ongur--who was not involved in the asenapine studies--the sublingual preparation should be helpful for the small subset of patients with schizophrenia and bipolar disorder who have swallowing problems.

The FDA approval was announced about 2 weeks after the agency's Psychopharmacologic Drugs Advisory Panel agreed at a meeting that the short-term data on asenapine showed it was effective and safe for the acute treatment of schizophrenia in adults and of mania/mixed episodes in adults with bipolar I disorder.

Panelists cited the need for another treatment option, but expressed concerns about the lack of long-term data on asenapine and emphasized the need for long-term follow-up studies ("Sublingual Antipsychotic Gets Nod From FDA Panel," August 2009, p. 1).

Dr. Ongur sees the lack of long-term data as a problem that plagues the field. "These studies sometimes lag introduction of the new medications by a decade," he said.

Ideally, Dr. Ongur said, long-term studies would focus on maintenance on medications and outcomes that are important to patients, families, and physicians, such as returning to school, to be able to live independently, and having meaningful relationships. …

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