Allergan plc today announced that SAPHRIS® (asenapine) 2.5 mg sublingual (placed under the tongue) black-cherry flavored tablets are available in pharmacies throughout the U.S. In March 2015, the U.S. Food and Drug Administration (FDA) approved SAPHRIS for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 – 17).
"The approval of the pediatric indication and the availability of SAPHRIS 2.5 mg tablets at pharmacies throughout the U.S. means that children, teens and their physicians will have a new treatment option available for this complex disorder," said David Nicholson, Executive Vice President Global R&D at Allergan.
Approximately half a million children and teens in the U.S. have experienced symptoms of bipolar I disorder at some time in their lives. Patients with bipolar I disorder experience "mood episodes", which include manic episodes or mixed episodes (consisting of symptoms of both mania and depression). Often, younger patients with bipolar I disorder experience more frequent mood episodes than adults.
"Children with bipolar I disorder can present with varying symptoms and needs, which requires that physicians address the critical need for individualized treatment," said Adelaide Robb, MD, Chief of the Division of Psychology and Behavioral Health, Children's National Medical Center. "SAPHRIS provides an important option for pediatric patients living with this debilitating and serious psychiatric mood disorder."
The FDA approval of SAPHRIS was based on the results of a 3-week monotherapy trial in 403 pediatric patients (ages 10 – 17), the largest registrational pediatric bipolar I mania trial for an atypical antipsychotic to date.i Of pediatric patients enrolled in the trial, 302 received SAPHRIS in doses of either 2.5 mg twice daily, 5 mg twice daily or 10 mg twice daily. 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 at endpoint at each dose. 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.