The Medical Letter on Drugs and Therapeutics
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ISSUE 1617
ISSUE 1617
February 8, 2021
Pitolisant (Wakix) for Narcolepsy
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February 8, 2021 (Issue: 1617)
The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H3)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. It is the first H3-receptor antagonist/inverse agonist to become available in the US and the first non-controlled substance to receive FDA approval for these indications. Pitolisant has been available in Europe since 2016.
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- Solriamfetol (Sunosi) for excessive daytime sleepiness. Med Lett Drugs Ther 2019; 61:132.
- JF Pagel. Excessive daytime sleepiness. Am Fam Physician 2009; 79:391.
- TI Morgenthaler et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin. Sleep 2007; 30:1705.
- Y Dauvilliers et al. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol 2013; 12:1068.
- European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). Assessment report: Wakix. November 19, 2015. Available at: https://bit.ly/2LqPP9u. Accessed January 21, 2021.
- Y Dauvilliers et al. Long-term use of pitolisant to treat patients with narcolepsy: Harmony III study. Sleep 2019; 42:zsz174.
- Z Szakacs et al. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 2017; 16:200.
- Inhibitors and inducers of CYP enzymes and P-glycoprotein. Med Lett Drugs Ther 2019 September 10 (epub). Available at: medicalletter.org/downloads/CYP_PGP_Tables.pdf.
- RL Woosley et al. QT drugs list. Available at: www.crediblemeds.org. Accessed January 21, 2021.

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