FDA approves Saphris from Actavis

DUBLIN — Actavis on Friday announced that the Food and Drug Administration approved Saphris (asenapine) for the treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10-to-17 years.) Actavis stated that Saphris is the only antipsychotic treatment option with a formulation that is administered under the tongue.

 

Patients with bipolar I disorder experience manic episodes, depressive episodes or a combination of the two. According to the company, 1.2 million children and teens in the United States meet the criteria for the disorder; younger patients with the disorder experience such mood episodes more frequently. 

 

"Bipolar I disorder in children and teens is a significant public health problem in the U.S. The diagnosis and recognition of bipolar I disorder in children and teens continues to rise, and this illness can often be more severe in pediatric patients than adults," said Kiki Chang, MD, professor of psychiatry and behavioral sciences at Stanford University School of Medicine, division of child psychiatry. "The FDA approval of this pediatric indication for Saphris is very important because it provides an additional treatment option for children and teens affected by this complex condition.

 

Saphris will be available in 2.5-, 5- and 10-mg black cherry flavor sublingual tablets in second-quarter 2015, the company stated.