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

WAKIX significantly reduced EDS versus placebo in Study 1

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 placebo^1,‡

Patient population

Baseline mean ESS scores reflected severe EDS^2,§
- Placebo: 18.9
- WAKIX: 17.8
61% of all WAKIX-treated patients reached a stable dosage of 35.6 mg once daily

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 in ESS score from baseline to mean of 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.

Download EDS clinical data
overview in adult patients »

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

WAKIX resulted in significantly fewer weekly cataplexy attacks versus placebo in Study 3

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

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).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.

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.

Download cataplexy clinical data
overview in adult patients »

See efficacy data in pediatric patients »See safety and tolerability profile in adult and pediatric patients »