WAKIX Significantly Reduced EDS Versus Placebo in 
Two Clinical Studies

WAKIX clinical study results in EDS

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,‡

Study 1: Reduction in ESS Score From Baseline1,‡

Patient population

  • ICSD-2 diagnosis of narcolepsy including almost daily EDS for ≥3 months1
  • Mean ESS scores at baseline reflected severe EDS2,§
    • ­WAKIX: 17.8
    • ­­Placebo: 18.9
  • 61% of all patients taking WAKIX reached a stable dosage of 35.6 mg once daily
  • ~80% of patients had a history of cataplexy

*Primary endpoint: Least square (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 Lower ESS score represents improvement; scores range from 0 (no symptoms) to 24 (worst symptoms). Placebo-subtracted difference (95% CI -5.73, -0.46). LS mean change in ESS score from baseline to the mean of 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.

EDS, excessive daytime sleepiness; ESS, Epworth Sleepiness Scale; ICSD-2, International Classification of Sleep Disorders, Second Edition.

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.

STUDY 2: 17.8 mg once daily maximum potential dosage

  • Primary endpoint: the final mean ESS score* with WAKIX was 13.3 versus 15.5 with placebo (2.2-point difference, P=0.03)1,†
  • WAKIX demonstrated a 5-point mean reduction in ESS score from baseline versus 2.8 points with placebo1,‡

Study 2: Reduction in ESS Score From Baseline1,‡

Patient population

  • ICSD-2 diagnosis of narcolepsy including almost daily EDS for ≥3 months1
  • Mean ESS scores at baseline reflected severe EDS2,§
    • ­WAKIX: 18.3
    • ­­Placebo: 18.2
  • 76% of all patients taking WAKIX reached a stable dosage of 17.8 mg once daily
  • 75% of patients had a history of cataplexy

*Primary endpoint: LS mean final ESS score compared with placebo. Final values shown as LS mean at Week 8. Lower ESS score represents improvement; scores range from 0 (no symptoms) to 24 (worst symptoms). Placebo-subtracted difference (95% CI -4.17, -0.22). LS mean change in ESS score from baseline to Week 8; adjusted mean ESS score at baseline was 18.3.1 §Baseline values shown as raw mean values.

EDS, excessive daytime sleepiness; ESS, Epworth Sleepiness Scale; ICSD-2, International Classification of Sleep Disorders, Second Edition.

Study 2 was an 8-week, multicenter, randomized, double-blind, placebo-controlled study in 98 adults with narcolepsy with or without cataplexy (based on ICSD-2 criteria). WAKIX was initiated at 4.45 mg once daily and could be increased at weekly intervals to 8.9 mg or 17.8 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, or 17.8 mg once daily for an additional 5 weeks.

Understanding WAKIX Clinical Data for Excessive Daytime Sleepiness (EDS) in Narcolepsy

Dr. Haramandeep Singh

Watch Haramandeep Singh, MD, a board-certified psychiatrist and sleep specialist, as he presents clinical data for WAKIX. Dr. Singh explains the proven efficacy of WAKIX in EDS, the safety profile of WAKIX, and the evaluation of EDS using the Epworth Sleepiness Scale (ESS).

Excessive Daytime Sleepiness, Clinical Data explained by sleep specialist video, Dr. Haramandeep Singh
Clinical Data for Excessive Daytime Sleepiness Leave Behind

WAKIX Clinical Data for EDS

Review data from clinical studies of WAKIX for the treatment of excessive daytime sleepiness in adults with narcolepsy.

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