WAKIX Resulted in Significantly Fewer Cataplexy Attacks Versus Placebo in Two Clinical Studies

WAKIX clinical study results in cataplexy

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

Study 3: Baseline and Final Mean Weekly Cataplexy Rate

Patient population

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

*Primary endpoint: Final mean weekly rate of cataplexy over the 4-week stable dosing period compared with placebo (adjusted for baseline differences).1 Rate ratio 0.51 (95% CI 0.44, 0.60); results were statistically significant.1 Statistical comparison of geometric mean values was not conducted.

ICSD-2, International Classification of Sleep Disorders, Second Edition.

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.

STUDY 1: 35.6 mg once daily maximum potential dosage

  • In a supportive study, WAKIX resulted in significantly fewer mean daily cataplexy attacks at Week 8 compared with placebo1,*
  • WAKIX reduced the number of daily cataplexy attacks

Study 1: Baseline and Final Mean Daily Cataplexy Rate

Patient population

  • Subset of 49 patients had a history of cataplexy
  • 61% of all patients with or without cataplexy taking WAKIX reached a stable dosage of 35.6 mg once daily

*Secondary endpoint: Final mean daily rate of cataplexy at Week 8 compared with placebo (adjusted for baseline differences).1 Evaluated in a subset of 49 patients with a history of cataplexy. Rate ratio 0.07 (95% CI 0.01, 0.36); results were statistically significant.1 Statistical comparison of geometric mean values was not conducted.

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.

Understanding WAKIX Clinical Data for Cataplexy

Dr. Asim Roy

Hear from Asim Roy, MD, a board-certified neurologist and sleep specialist, as he discusses the clinical studies for WAKIX in cataplexy and the safety profile of WAKIX.

WAKIX Clinical Data for Cataplexy with Dr. Asim Roy video
WAKIX Clinical Data for Cataplexy overview

WAKIX Clinical Data for Cataplexy

Review data from clinical studies of WAKIX for the treatment of cataplexy in adults with narcolepsy.

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