Actavis has announced that the U.S. Food and Drug Administration (FDA) has approved its 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.”
