PPA News



Posted by: Dale Whitby on Mar 19, 2015

This notice was prepared by Dale Whitby, PharmD (PPAG Member)

On March 12, 2015 the FDA approved asenapine (Saphris) for use as monotherapy in the treatment of manic or mixed episodes in children and adolescents 10 to 17 years of age with bipolar I disorder. Asenapine is a second-generation atypical antipsychotic medication that is available as a sublingual tablet, which may be particularly useful for patients who have difficulty swallowing solid dosage forms.

The FDA approval of SAPHRIS is based on the results of a 3-week, placebo-controlled, double-blind trial in 403 pediatric patients (ages 10 – 17), of which 302 pediatric patients received asenapine twice daily in doses of either 2.5 mg, 5 mg, or 10 mg. The recommended initial dosage for pediatric patients is 2.5 mg twice daily with an increase in dosage every three days up to a maximum of 10 mg twice daily.

In the 3-week, placebo-controlled pediatric trial, some of the most common adverse events were somnolence, dizziness, oral paresthesia, headache, and weight gain. No new major safety findings were reported from a 50-week, open-label, uncontrolled trial in pediatric patients with bipolar disorder treated with asenapine monotherapy; however, in a phase 1 study, pediatric patients appeared to be at higher risk for dystonia with initial dosing compared to older age groups when the recommended dosage titration schedule was not followed.

According to the manufacturer, asenapine will be available for pediatric patients with bipolar I disorder in 2.5 mg, 5 mg, and 10 mg black cherry flavor sublingual tablets in Q2 2015.

For more information:

accessdata.fda.gov/scripts/cder/drugsatfda/?fuseaction=Search.DrugDetails

actavis.com/news/news/thomson-reuters/actavis-receives-fda-approval-of-saphris-for-pedia