Data from two clinical studies evaluating the long-term safety and efficacy, as well as the human abuse potential of WAKIX (pitolisant), have been published in SLEEP. WAKIX, marketed by Harmony Biosciences LLC, is a first-in-class medication with a novel mechanism of action and is approved for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. It is the first US Food and Drug Administration (FDA) approved product for patients with narcolepsy that is not scheduled as a controlled substance by the US Drug Enforcement Administration.
The manuscripts published in SLEEP are as follows:
Long-term use of pitolisant to treat patients with narcolepsy: HARMONY III Study
An open-label, long-term (up to 5 years) study of pitolisant in patients with narcolepsy. The manuscript focuses on findings from a one-year analysis that assessed the long-term safety and efficacy of pitolisant in the treatment of excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.
Evaluation of the abuse potential of pitolisant, a selective H3-receptor antagonist/inverse agonist, for the treatment of adult patients with narcolepsy with or without cataplexy
Results from a randomized, double-blind, active- and placebo-controlled, four-sequence, four-way crossover study which evaluated the human abuse potential of single-dose pitolisant compared with the stimulant phentermine HCl (C-IV) and placebo in non-dependent, recreational stimulant users.
“We are pleased to see these data, which support the benefit/risk profile of WAKIX, published in SLEEP,” says Harmony chief medical officer, Jeffrey Dayno, MD, in a release. “These publications will provide healthcare professionals additional scientific evidence in support of WAKIX, including information on long-term safety and efficacy, as well as data on its lack of abuse potential, both of which are important considerations when treating people who live with narcolepsy.”
Data from both studies were also presented at the recent World Sleep 2019 meeting in Vancouver, Canada.