WAKIX Significantly Reduced Excessive Daytime Sleepiness Versus Placebo

WAKIX efficacy data from two clinical studies

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: ESS Score Reduction From Baseline1,‡

Patient population

  • ICSD-2 narcolepsy diagnosis with almost daily EDS for ≥3 months1
  • Baseline mean ESS scores reflected severe EDS2,§
    • WAKIX: 17.8
    • Placebo: 18.9
  • 61% of all WAKIX-treated patients 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 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: ESS Score Reduction From Baseline1,‡

Patient population

  • ICSD-2 narcolepsy diagnosis with almost daily EDS for ≥3 months1
  • Baseline mean ESS scores reflected severe EDS2,§
    • WAKIX: 18.3
    • Placebo: 18.2
  • 76% of all WAKIX-treated patients reached a stable dosage of 17.8 mg once daily
  • 75% 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 at Week 8. 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.