The US Food and Drug Administration has approved the atypical antipsychotic Saphris (asenapine) for use in “manic or mixed episodes associated with bipolar I disorder in pediatric patients” aged 10-17. The approval, according to Medscape, came as a result of positive results in only one clinical trial that lasted just three weeks.
“All three dose levels were associated with improvements in both mania and overall disease severity compared with placebo,” reported Psychiatric News. “Side effects included sleepiness, dizziness, strange taste sensations, numbness of the mouth, nausea, tiredness, increased appetite, and weight gain.”
FDA Approves Antipsychotic for Treatment of Pediatric Bipolar Disorder (Psychiatric News, March 13, 2015)
FDA Okays Saphris for Pediatric Bipolar Disorder (Medscape, March 13, 2015. Free registration.)