WAKIX (pitolisant), histamine H3 inverse agonist/antagonist
NEUROLOGY - New medicinal product
Opinions on drugs - Posted on Oct 14 2016
Reason for request
- WAKIX has Marketing Authorisation in the treatment of adults with narcolepsy with or without cataplexy.
- In a single short-term study, it reduced daytime sleepiness versus placebo without demonstrating non-inferiority versus modafinil.
- Its efficacy on cataplexy, another characteristic symptom of narcolepsy, was only demonstrated short-term versus placebo in very severe patients.
Improvement in actual benefit
Évaluation des médicaments