The US Food and Drug Administration (FDA) has approved Actavis' supplemental new drug application (sNDA) for Saphris (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 - 17). Saphris is the only atypical antipsychotic treatment option with a sublingual (under the tongue) formulation.

Approximately 1.2 million children and teens in the United States meet the criteria for bipolar I disorder. Patients with bipolar I disorder experience "mood episodes" ranging from manic episodes, depressive episodes, or mixed episodes (a combination of both mania and depression). Often, younger patients with bipolar I disorder experience more frequent mood episodes.

"We were pleased to see that Saphris was effective across a range of doses, in the largest registrational pediatric trial for an atypical antipsychotic in bipolar I disorder," said David Nicholson, executive vice president global R&D at Actavis. "Saphris is the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last five years. As part of our commitment to mental health, we look forward to making this treatment option available to patients as soon as possible."

The FDA approval of Saphris is based on the results of a 3-week monotherapy trial in 403 pediatric patients (ages 10 - 17), of which 302 pediatric patients received Saphris twice daily in doses of either 2.5 mg, 5 mg or 10 mg.

Saphris was shown to demonstrate improvement in Young Mania Rating Scale (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) Severity of Illness overall score versus placebo in a pediatric clinical trial.

"Bipolar I disorder in children and teens is a significant public health problem in the US. 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, 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."

In the pediatric clinical trial the most common side effects that occurred with Saphris were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain.

Saphris will be available for pediatric patients with bipolar I disorder in 2.5 mg, 5 mg and 10 mg black cherry flavor sublingual tablets in Q2 2015.

Saphris (asenapine) is a second-generation atypical antipsychotic that was initially approved in 2009 and is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy or as adjunctive therapy with either lithium or valproate, and for the acute and maintenance treatment of schizophrenia in adults. It is now also indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 - 17) as monotherapy. More than one million prescriptions for Saphris have been dispensed since its initial approval. As of December 2014, asenapine is available in 62 countries.

actavis plc, headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.