Patient population

Mean PDSS total scores at baseline^1,‡
- Placebo: 20.0
- WAKIX: 20.2

CI, confidence interval; LS, least squares; PDSS, Pediatric Daytime Sleepiness Scale.

*Placebo-subtracted difference (95% CI: -5.52, -1.31).

^†LS mean change in PDSS total score from baseline to mean of the final 2 weeks (Week 7 and Week 8).¹

^‡Baseline values shown as raw mean values.¹

Study 4 design

Study 4 was an 8-week, multicenter, randomized, double-blind, placebo-controlled study in 110 pediatric patients 6 to 17 years of age with narcolepsy with or without cataplexy (based on ICSD-3 criteria). WAKIX was initiated at 4.45 mg once daily and could be increased at weekly intervals to 17.8 mg (patients weighing <40 kg) or 35.6 mg (patients weighing ≥40 kg) once daily based on clinical response and tolerability. After the 4-week titration period, patients were treated with a stable dosage for an additional 4 weeks. No dosage adjustments were permitted during the stable dose phase.

ICSD-3, International Classification of Sleep Disorders, 3rd edition.

WAKIX Resulted in Significantly Fewer Weekly Cataplexy Attacks Versus Placebo in Pediatric Patients 6 Years and Older With Narcolepsy

Significant improvement in LS mean from baseline to end of treatment for the WRC^§
WRC at the end of treatment with WAKIX was 2.2 versus 5.6 with placebo

Patient population

Subset of 95 patients with a history of cataplexy
Mean WRC at baseline²
- Placebo: 14.1
- WAKIX: 9.9

CI, confidence interval; LS, least squares; WRC, weekly rate of cataplexy.

^§Final mean WRC at Week 8 compared with placebo. Rate ratio 0.39 (95% CI: 0.17, 0.90; adjusted for baseline value).

Study 4 design

Study 4 was an 8-week, multicenter, randomized, double-blind, placebo-controlled study in 110 pediatric patients 6 to 17 years of age with narcolepsy with or without cataplexy (based on ICSD-3 criteria). WAKIX was initiated at 4.45 mg once daily and could be increased at weekly intervals to 17.8 mg (patients weighing <40 kg) or 35.6 mg (patients weighing ≥40 kg) once daily based on clinical response and tolerability. After the 4-week titration period, patients were treated with a stable dosage for an additional 4 weeks. No dosage adjustments were permitted during the stable dose phase.

ICSD-3, International Classification of Sleep Disorders, 3rd edition.

WAKIX Significantly Reduced Excessive Daytime Sleepiness Versus Placebo in Pediatric Patients 6 Years and Older With Narcolepsy

WAKIX Resulted in Significantly Fewer Weekly Cataplexy Attacks Versus Placebo in Pediatric Patients 6 Years and Older With Narcolepsy