Asenapine Approved for Treatment of Schizophrenia, Bipolar Disorder

Kate Traynor

BETHESDA, MD 14 August 2009—FDA and Schering-Plough Corporation today announced the approval of asenapine sublingual tablets for the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults.

Schering-Plough expects the atypical antipsychotic drug to be available during the final quarter of this year under the brand name Saphris.

As with other drugs in the class, the labeling (PDF) for asenapine includes a boxed warning stating that the drug is "not approved" for use in elderly patients with dementia-related psychosis. Patients with this condition who are treated with antipsychotic drugs are at increased risk of death, the labeling warns.

The labeling also warns that cerebrovascular accidents and transient ischemic attacks have occurred in elderly patients with dementia-related psychosis when treated with antipsychotic drugs.

Efficacy data on asenapine were collected during three six-week clinical trials in patients with schizophrenia and two three-week trials in patients with bipolar disorder. According to FDA, the drug outperformed placebo in both bipolar-disorder trials and two of the schizophrenia studies.

The most frequent adverse events reported by clinical trial participants with schizophrenia were restlessness, decreased oral sensitivity, and drowsiness. Among patients with bipolar disorder, the most frequent adverse events were drowsiness, dizziness, movement disorders, and weight gain.

Instances of tardive dyskinesia, a serious movement disorder, were reported during clinical trials of asenapine. The labeling states that if this condition occurs, consideration should be given to discontinuing therapy when "clinically appropriate."

Cessation of therapy is also recommended if neuroleptic malignant syndrome (NMS), a life-threatening neurologic condition associated with the use of antipsychotic drugs, occurs during treatment with asenapine. Symptoms of NMS include "high fever, sweating, unstable blood pressure, stupor, muscular rigidity, and autonomic dysfunction," according to the National Institute of Neurological Disorders and Stroke.

Other serious conditions that may occur during treatment with asenapine or other atypical antipsychotic drugs include hyperglycemia, diabetes mellitus, and orthostatic hypotension.

The recommended starting dosage of asenapine in adults with schizophrenia is 5 mg taken twice daily. For patients with bipolar disorder, the recommended starting dosage is 10 mg taken twice daily. If this dosage is not tolerated, the labeling recommends reducing the dosage to 5 mg taken twice daily.

Asenapine 5- and 10-mg tablets will be sold in 10-tablet blister packs in boxes of 60 or 100. Each tablet should remain in the blister pack until needed and then removed with dry hands. The tablet should be placed under the tongue and allowed to dissolve completely, and the patient should not eat or drink for 10 minutes after taking the tablet.

The labeling warns against crushing, chewing, or swallowing the sublingual tablets.