WAKIX PrescriptionWAKIX Significantly Reduced Excessive Daytime Sleepiness Versus Placebo in Adult Patients
Dr. Debra Stultz
Board-certified psychiatrist and sleep specialist
Efficacy in Adult Patients
Explore WAKIX efficacy data in excessive daytime sleepiness (EDS) from clinical studies including adult patients with narcolepsy type 1 and narcolepsy type 2
Study 1
Study 2
Study 1 (Post Hoc Analysis)EDS Over Time
Studies 1 & 3 (Post Hoc Analysis)Severe 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,‡
Patient population
- Baseline mean ESS scores reflected severe EDS2,§
- Placebo: 18.9
- WAKIX: 17.8
- 61% of all WAKIX-treated patients reached a stable dosage of 35.6 mg once daily
- ~80% of patients had a history of cataplexy
CI, confidence interval; ESS, Epworth Sleepiness Scale; LS, least squares.
*Primary endpoint: 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 from baseline to the 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.
Study 1 design
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.
ICSD-2, International Classification of Sleep Disorders, 2nd edition.
WAKIX Resulted in Significantly Fewer Cataplexy Attacks Versus Placebo in Adult Patients
Dr. Abhinav Singh
Board-certified internal medicine and sleep specialist
Explore WAKIX efficacy data in cataplexy from clinical studies in adult patients with narcolepsy type 1
Study 3
Study 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
Patient population
- 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
CI, confidence interval.
*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, 2nd edition.