Wakix OK'd for use in children with narcolepsy

FDA expanded the approval of pitolisant (Wakix) to include treatment of excessive daytime sleepiness in pediatric patients ≥6 years of age with narcolepsy. Approval of the new indication was based on data from a phase 3 trial involving 110 pediatric patients ages 6 to 17 years. In the trial, treatment with pitolisant resulted in significantly greater improvements in Pediatric Daytime Sleepiness Scale (PDSS) scores compared with placebo.