Actavis’ Atypical Antipsychotic Saphris for Bipolar Kids Receives FDA Nod

The FDA approved an under-the-tongue formulation of Actavis’ atypical antipsychotic Saphris for 10- to 17-year-old children with bipolar 1 disorder. The company plans to begin marketing the new formulation in the second quarter.

Saphris (asenapine) tablets were first approved in 2009 for adults with bipolar 1 or schizophrenia alone or in combination with lithium or valproate. Friday’s expanded approval covers those tablets, as well as black cherry-flavored sublingual tablets in 2.5 mg, 5 mg and 10 mg doses for pediatric patients with either mania or mixed symptoms of mania and depression.

The FDA based its approval on results from a three-week trial of 403 children that showed improvement in two different bipolar severity scales among those who got Saphris twice daily. This is the largest registrational pediatric trial of an atypical antipsychotic, the company said.

This marks the first approval of a new atypical antipsychotic for children with bipolar 1 in five years and will give young patients another therapeutic option to help calm manic episodes, says Kiki Chang, a professor of psychiatry and behavioral sciences at Stanford University.

The under-the-tongue formulation will also help children who cannot swallow pills or have trouble swallowing liquids, he says.

Saphris brought Actavis some $70 million in revenues in 2014. — Lena Freund