Pitolisant is the first of a new class of medicine licensed to treat narcolepsy with or without cataplexy, and is an additional option that could be used in this rare condition. No participants in the pitolisant groups had withdrawal syndrome during the withdrawal phase. In the 2 RCTs reviewed in this evidence summary, the most common adverse events in the pitolisant groups were headache, insomnia, abdominal discomfort, nausea, irritability and anxiety. Narcolepsy is an orphan disease, and clinical studies included small numbers of people for a short duration of time. The long‑term safety data for pitolisant in people with narcolepsy are limited. Non-inferiority to modafinil was not shown. Pitolisant was also compared with modafinil in a non-inferiority analysis (an analysis designed to test if it was not worse than modafinil for improving excessive daytime sleepiness by a pre-specified amount). Compared with placebo, pitolisant improved excessive daytime sleepiness, improved time awake in a darkened room and reduced the weekly cataplexy rate. This evidence summary reviewed 2 small randomised controlled trials (RCTs) of pitolisant 5–40 mg per day in adults with narcolepsy with or without cataplexy. Narcolepsy is a rare, disabling long‑term brain disorder that can result in excessive daytime sleepiness, sleep attacks, cataplexy, sleep paralysis, excessive dreaming and disturbed nocturnal sleep. It was launched in the UK in September 2016. Pitolisant is a histamine H3‑receptor antagonist/inverse agonist that is licensed for the treatment of narcolepsy with or without cataplexy in adults. See summaries of product characteristics (SPC), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. The content of this evidence summary was up-to-date in March 2017.
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