FDA approves Saphris for bipolar I disorder in pediatric patients
The FDA approved Saphris for the acute treatment of pediatric patients with bipolar I disorder, according to an Actavis press release.
Saphris (asenapine, Actavis) is an atypical antipsychotic used for manic or mixed episodes associated with the disorder. It is available in sublingual tablet form.
The approval is based widely on results from a 3-week monotherapy trial assessing the safety and efficacy of the drug in 403 pediatric patients (aged 10 to 17 years). Of those, 302 patients were administered Saphris twice daily at dosage strengths of 2.5 mg, 5 mg or 10 mg, according to the press release.
The drug improved Young Mania Rating Scale total scores and Clinical Global Impression-Bipolar Severity of Illness overall scores, compared with placebo.
Common adverse events included sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain.
“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,” Kiki Chang, MD, professor of psychiatry and behavioral sciences at Stanford University School of Medicine, in the division of child psychiatry, said in the release. “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 is currently available in 5 mg and 10 mg sublingual tablets for adult patients. It will now also be available on the 2.5 mg black cherry flavor sublingual tablet in the second quarter of 2015.
Editor's Note: On March 13, we corrected the second and last paragraph of this article to clarify that Saphris now comes in a sublingual tablet formulation. The Editors regret this error.
ClinicalTrials.gov Identifier: NCT01244815.