Efficacy in Adult Patients
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WAKIX Significantly Reduced Excessive Daytime Sleepiness Versus Placebo in Adult Patients

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Dr. Debra Stultz

Board-certified psychiatrist and sleep specialist

Explore WAKIX efficacy data in excessive daytime sleepiness (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

CI, confidence interval; 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, 2nd edition.

WAKIX Resulted in Significantly Fewer Cataplexy Attacks Versus Placebo in Adult Patients

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Dr. Abhinav Singh

Board-certified internal medicine 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

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



CI, confidence interval.

*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

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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, 2nd edition.
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References

  1. Data on file. Harmony Biosciences.
  2. Johns M. About the ESS. Accessed June 12, 2024. http://epworthsleepinessscale.com/about-the-ess
  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 J-C, 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.