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FDA Expands Labeling for Saphris (Asenapine) to Include Treatment of Pediatric Patients With Bipolar I Disorder

Only atypical antipsychotic with sublingual formulation

The FDA has approved a supplemental new drug application for Saphris (asenapine, Actavis) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (10 to 17 years of age). Saphris is the only atypical antipsychotic treatment option with a sublingual formulation.

Approximately 1.2 million children and teenagers in the U.S. meet the criteria for bipolar I disorder. Patients with bipolar I disorder experience manic episodes (i.e., overexcited, extreme irritability, racing thoughts, difficulties with sleep); depressive episodes (i.e., extreme sadness, fatigue, hopelessness); or mixed episodes (a combination of both mania and depression). Younger patients with bipolar I disorder experience more-frequent mood episodes.

Asenapine is a second-generation atypical antipsychotic that was initially approved in 2009. The drug is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy or as adjunctive therapy with either lithium or valproate, and for the acute and maintenance treatment of schizophrenia in adults.

The FDA’s new approval was based on results from a 3-week monotherapy trial in 302 pediatric patients (10 to 17 years of age) who received asenapine twice daily in doses of 2.5 mg, 5 mg, or 10 mg. Asenapine was shown to improve the Young Mania Rating Scale (YMRS) total score and the Clinical Global Impression–Bipolar (CGI-BP) severity of illness overall score compared with placebo.

“Bipolar I disorder in children and teens is a significant public health problem in the U.S. The diagnosis and recognition of bipolar I disorder in children and teens continue to rise, and this illness can often be more severe in pediatric patients than in adults,” said Kiki Chang, MD, Professor of Psychiatry and Behavioral Sciences at Stanford University School of Medicine. “The FDA approval of this pediatric indication for Saphris is very important because it provides an additional treatment option for children and teens affected by this complex condition.”

In the pediatric clinical trial, the most common adverse events associated with asenapine included sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain.

Saphris (asenapine) will be available for pediatric patients with bipolar I disorder in 2.5-mg, 5-mg, and 10-mg black cherry-flavored sublingual tablets in the second quarter of 2015.

More than one million prescriptions for asenapine have been dispensed since its initial approval in 2009. As of December 2014, the drug is available in 62 countries.

Source: Actavis; March 13, 2015.

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