The Sleep Forum Podcast

The Sleep Forum Podcast


Podcast: WAKIX is the first and only non-scheduled treatment approved for patients with narcolepsy in the U.S.

September 26, 2019

“The conclusion from this study, and other evidence, supported that WAKIX has significantly lower potential for abuse and drug ‘liking’, and that’s what lead to its approval by the FDA and becoming the first and only drug approved by the FDA for patients with narcolepsy that is not scheduled as a controlled substance by the DEA,” says said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. In this podcast, recorded live at this week’s Vancouver World Sleep Congress, Dayno discusses WAKIX and the results from a double-blind, active- and placebo-controlled, four-sequence, four-way crossover study that evaluated the abuse potential of pitolisant compared with the stimulant phentermine HCl (C-IV) and placebo in non-dependent, recreational stimulant users. WAKIX was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. “It is not a stimulant,” says Dayno. Dayno outlines how stimulants work and how WAKIX is a first-in-class medication with a novel mechanism of action. Dayno discusses how that mechanism works and what patients might expect in using the new drug. Learn more at https://www.harmonybiosciences.com/