A commentary notes that the main limitation of the study is that the diagnosis of narcolepsy was based on criteria that were not specific; though after the study had started, new more specific diagnostic criteria for narcolepsy were published, thus confirmatory studies on the effect of pitolisant on cataplexy will be based on these new criteria. It adds that despite this and other limitations, it is hoped this study will contribute to approval of pitolisant for treatment of cataplexy in patients with narcolepsy for whom there are currently few therapeutic options.
Pitolisant, a histamine H3 receptor inverse agonist, is currently licensed in the UK for use in adults for the treatment of narcolepsy with or without cataplexy.