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Cataplexy Results

WAKIX Resulted in Significantly Fewer Cataplexy Attacks Versus Placebo

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Video thumbnail WAKIX clinical data for cataplexy explained by sleep specialist Asim Roy
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Dr. Asim Roy

Board-certified neurologist and sleep specialist

Explore WAKIX efficacy data in cataplexy from clinical studies in adult patients with narcolepsy type 1

STUDY 3: 35.6 mg once daily maximum potential dosage

  • WAKIX resulted in approximately half the number of mean weekly cataplexy attacks during the 4-week stable dosing period compared with placebo*
  • WAKIX reduced the number of weekly cataplexy attacks
Bar graph of number of cataplexy attacks per week at baseline and final with WAKIX versus placebo

Patient population

  • All patients had ≥3 cataplexy attacks per week at baseline
  • 65% of all WAKIX-treated patients reached a stable dosage of 35.6 mg once daily

LS, least squares.

*Primary endpoint: Final mean weekly rate of cataplexy over the 4-week stable dosing period compared with placebo (adjusted for baseline differences). Rate ratio 0.51 (95% CI: 0.44, 0.60); results were statistically significant.1

Statistical comparison of geometric mean values was not conducted.

Study 3 design

Study 3 was a 7-week, multicenter, randomized, double-blind, placebo-controlled study in 105 adults with narcolepsy with cataplexy (based on ICSD-2 criteria). WAKIX was initiated at 4.45 mg once daily for the first week, increased to 8.9 mg once daily for the second week, and could remain the same or be decreased or increased at the next two weekly intervals to a maximum of 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 4.45 mg, 8.9 mg, 17.8 mg, or 35.6 mg once daily for an additional 4 weeks.
ICSD-2, International Classification of Sleep Disorders, Second Edition.
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  1. Data on file. Harmony Biosciences.
  2. 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.
  3. 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.