The FDA has accepted for filing Actavis' supplemental New Drug Application (sNDA) for Saphris (asenapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age. Actavis' sNDA for Saphris has been granted priority review status by the FDA.
"The sNDA filing of Saphris speaks to our commitment to ongoing R&D of our mental health portfolio," said C. David Nicholson, Ph.D., senior vice president, Actavis Global Brands R&D. "We are pleased that the FDA has accepted this sNDA, marking the first step towards our goal of bringing this important antipsychotic treatment option to pediatric patients."
Actavis expects the Prescription Drug User Fee Act (PDUFA) date to be in Q1 2015. The sNDA submission for asenapine is based on the results of a three-week monotherapy trial in 403 pediatric patients (10 to 17 years of age), 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 (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) score at fixed doses of 2.5mg, 5mg and 10mg twice daily.
The most commonly observed adverse reactions (incidence >= 5% and at least twice that for placebo) were somnolence, dizziness, dysgeusia, oral hypoesthesia, oral paresthesia, nausea, increased appetite, fatigue and increased weight.