FDA Accepts Actavis' Filing Of SNDA For Saphris - Quick Facts

(RTTNews) - Actavis plc (ACT) Thursday said the U.S. Food and Drug Administration or FDA has accepted its filing of Supplemental New Drug Application or sNDA for Saphris or asenapine, and has granted priority review status for the same.

Saphris is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients aged between 10 and17 .

The sNDA submission was based on the data from a 3-week monotherapy trial in 403 pediatric patients, of whom 302 received asenapine. In the trial, asenapine was shown to be statistically superior to placebo in the reductions of both the Young Mania Rating Scale total score and Clinical Global Impression-Bipolar score at fixed doses of 2.5 mg, 5 mg and 10 mg twice daily.

The company expects the Prescription Drug User Fee Act date to be in the first quarter of 2015.