Dr. Asim Roy
Board-certified neurologist and sleep specialist
Explore WAKIX efficacy data in cataplexy from clinical studies in adult patients with narcolepsy type 1
Study 3 (Post Hoc Analysis)Cataplexy Over Time
Studies 1 & 3 (Post Hoc Analysis)Severe 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
- 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
LS, least squares.
*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
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, Second Edition.