FDA Grants Priority Review to Bipolar Indication for Schizophrenia Drug

Actavis's supplemental New Drug Application for asenapine to treat manic or mixed episodes related to bipolar disorder in pediatric patients has been accepted by the FDA and given priority review status.

Actavis’s supplemental New Drug Application (sNDA) for asenapine (Saphris) to treat manic or mixed episodes related to bipolar disorder in pediatric patients has been accepted by the FDA and given priority review status.

A little more than 400 patients aged 10 to 17 years old with bipolar I disorder participated in a 3-week monotherapy trial, of whom 302 received Saphris, a company press release stated. Compared with placebo, those who took twice-daily dosages of 2.5 mg, 5 mg, or 10 mg of the antipsychotic medication experienced greater reductions in their Young Mania Rating Scale and Clinical Global Impression-Bipolar scores.

The most common adverse reactions were somnolence, dizziness, dysgeusia, oral hypoesthesia, oral paresthesia, increased weight, nausea, increased appetite, and fatigue.

According to Actavis, Saphris has been prescribed more than 1 million times since it was first approved by the FDA in 2009. If the FDA expands that approval, the drug would also be used for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age.

"The sNDA filing of Saphris speaks to our commitment to ongoing research and development of our mental health portfolio," said C. David Nicholson, PhD, senior vice president at Actavis Global Brands R&D. "We are pleased that the FDA has accepted this sNDA, marking the first step toward our goal of bringing this important antipsychotic treatment option to pediatric patients."