FDA Approves New Pediatric Treatment for Bipolar Disorder

The FDA today approved the supplemental new drug application for asenapine (Saphris) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder for patients aged 10 to 17 years.

According to Actavis, Saphris is the only atypical antipsychotic treatment option with a sublingual formulation, which means it will dissolve when placed under the tongue. It is also the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the past 5 years, Actavis stated.

The FDA’s approval stemmed from the results of a 3-week trial involving 403 patients aged 10 to 17 years. Roughly 300 of the patients took Saphris twice daily in doses of 2.5 mg, 5 mg, or 10 mg. The results of the trial showed that Saphris improved Young Mania Rating Scale scores and Clinical Global Impression-Bipolar Severity of Illness scores compared with placebo.

Some side effects of Saphris include sleepiness, dizziness, strange sense of taste, numbing of the mouth, and nausea.

The treatment option is expected to be available to pediatric patients by the second quarter of 2015.

According to Actavis, Saphris was approved in 2009 for adults who had manic or mixed episodes related to bipolar I disorder, as either monotherapy or adjunctive therapy.