FDA approves Saphris (asenapine) for paediatriac bipolar 1 disorder- Actavis

Actavis plc announced that the 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.

Comment: The advantages of Saphris are less weight gain than with traditional antipsychotics and rapid efficacy, as early as day two. Unlike Zyprexa, it also provides significant improvement in depressive symptoms in manic episodes compared with placebo and has also demonstrated efficacy when combined with the mood stabilisers lithium or valproate.