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EDS Results

WAKIX Significantly Reduced Excessive Daytime Sleepiness Versus Placebo

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Dr. Debra Stultz

Board-certified psychiatrist and sleep specialist

Explore WAKIX efficacy data in EDS from clinical studies including adult patients with narcolepsy type 1 and narcolepsy type 2

STUDY 1: 35.6 mg once daily maximum potential dosage

  • Primary endpoint: the final mean ESS score* with WAKIX was 12.4 versus 15.5 with placebo (3.1-point difference, P=0.022)1,†
  • WAKIX demonstrated a 6-point mean reduction in ESS score from baseline versus 2.9 points with placebo1,‡

Patient population

  • Baseline mean ESS scores reflected severe EDS2,§
    • Placebo: 18.9
    • WAKIX: 17.8
  • 61% of all WAKIX-treated patients reached a stable dosage of 35.6 mg once daily
  • ~80% of patients had a history of cataplexy

EDS, excessive daytime sleepiness; ESS, Epworth Sleepiness Scale; LS, least squares.

*Primary endpoint: LS mean final ESS score compared with placebo. Final values shown as LS mean of the final 2 weeks (Week 7 and Week 8).1

Placebo-subtracted difference (95% CI: -5.73, -0.46).

LS mean change from baseline to the final 2 weeks (Week 7 and Week 8); adjusted mean ESS score at baseline was 18.4.1

§Baseline values shown as raw mean values.

Study 1 design

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Study 1 was an 8-week, multicenter, randomized, double-blind, placebo-controlled study in 61 adults with narcolepsy with or without cataplexy (based on ICSD-2 criteria). WAKIX was initiated at 8.9 mg once daily and could be increased at weekly intervals to 17.8 mg or 35.6 mg once daily based on clinical response and tolerability. After the 3-week titration period, patients were maintained on a stable dosage of 8.9 mg, 17.8 mg, or 35.6 mg once daily for an additional 5 weeks.
ICSD-2, International Classification of Sleep Disorders, Second Edition.
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  1. Data on file. Harmony Biosciences.
  2. Johns M. About the ESS. Accessed September 22, 2022.
  3. Watson NF, Davis CW, Zarycranski D, et al. Time to onset of response to pitolisant for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy: an analysis of randomized, placebo-controlled trials. CNS Drugs. 2021;35(12):1303-1315.
  4. Davis, CW, Kallweit U, Schwartz JC, Krahn LE, Vaugn B, Thorpy MJ. Efficacy of pitolisant in patients with high burden of narcolepsy symptoms: pooled analysis of short-term, placebo-controlled studies. Sleep Med. 2021;81:210-217.