Medscape: FDA Okays Saphris for Pediatric Bipolar Disorder
FDA Okays Saphris for Pediatric Bipolar Disorder
March 13, 2015
The US Food and Drug Administration (FDA) has approved another atypical antipsychotic for the treatment of pediatric patients with bipolar I disorder.
According to a release issued by the drug’s manufacturer, Actavis, asenapine (Saphris) received approval as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients aged 10 to 17 years.
The company notes that the drug is the only atypical antipsychotic treatment that offers a sublingual formulation.
According to the company, the FDA approval is based on the results of a 3-week monotherapy trial in 403 pediatric patients (aged 10 to 17 years), of whom 302 patients received Saphris twice daily in doses of either 2.5 mg, 5 mg, or 10 mg.
Read more at Medscape.