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As early as week 3,

Once-at-bedtime LUMRYZ provided statistically significant and clinically meaningful improvements for daytime symptoms1,2

Co-primary endpoints2

MWT CGI-I Mean change in weekly cataplexy attacks

Select secondary endpoint2

ESS

Participants in a qualitative study asked to rank aspects of a sodium oxybate treatment reported the ability to reduce the frequency and severity of daytime sleepiness as the most important.3*

Study Designstudy design icon

Patients taking once-at-bedtime LUMRYZ had more than twice the amount of wake time vs placebo1,2

Significant improvements were seen as early as week 3 (with a 6-g dose)1,2†

Primary Endpoint: MWT mean change from baseline in minutes1

MWT Change in sleep latency from baseline

Mean wake time graph

Patients who started as “markedly impaired” had significant improvements on once-at-bedtime LUMRYZ1,2

Significant improvements were seen as early as week 3 (with a 6-g dose)1†

Primary Endpoint: Investigator-assessed rating of “much improved” or “very much improved” CGI-I

CGI-I % of patients “much” or “very much” improved

Clinical global impression graph
73% 73% icon
of patients on LUMRYZ were rated by a clinician as “much” or “very much” improved.1‡

At week 13,

Once-at-bedtime LUMRYZ reduced weekly cataplexy attacks1,2

Significant improvements were seen as early as week 3 (with a 6-g dose)1†

Primary Endpoint: Mean change in number of cataplexy attacks from baseline

CATAPLEXY Change in number of weekly attacks from baseline

Cataplexy weekly attacks graph
61% 61% icon
Weekly cataplexy attacks decreased by 61% for patients on LUMRYZ at week 13.1

The number of cataplexy attacks per week was recorded daily in the sleep and symptom daily diary, with attacks recorded as 0, 1, 2, 3, 4, or 5 or more per day.2

Patients taking once-at-bedtime LUMRYZ were half as likely to doze during activities of daily living vs placebo as measured by ESS1,2,4

Significant improvements were seen as early as week 3 (with a 6-g dose)2

Secondary Endpoint: LSM change from baseline ESS score

ESS Select Secondary Endpoint | Change in score from baseline

Epworth sleepiness scale graph
The median ESS score was 9.5 at the 9-g dose, meaning half of patients on LUMRYZ scored within the range of normal daytime sleepiness.4

*Based on a qualitative study of 75 patients with experience taking twice-nightly sodium oxybate. Participants were asked to rate statements about aspects of sodium oxybate treatment on a scale of 1-9, where 1=“not at all important” and 9=“extremely important.”

†At week 3, all patients were on a 6-g dose before being titrated up to 7.5 g and then 9 g.

‡CGI-I at 9 g in the Kushida publication were 72%; LUMRYZ product labeling notes 73% for CGI-I.

CGI-I, Clinical Global Impression-Improvement; ESS, Epworth Sleepiness Scale; LSM, least mean squares; MWT, Maintenance of Wakefulness Test; NT1, narcolepsy type 1; NT2, narcolepsy type 2; SE, standard error.

References:

  1. References: 1. LUMRYZ. Package insert. Chesterfield, MO: Avadel Pharmaceuticals; 2023. 2. Kushida CA, Shapiro CM, Roth T, et al. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022;45(6):1-11. 3. Dubow J, Avidan AY, Corser B, et al. Preferences for attributes of sodium oxybate treatment: a discrete choice experiment in patients with narcolepsy. Patient Prefer Adherence. 2022;16:937-947. 4. Rosenberg R, Babson K, Menno D, et al. Test–retest reliability of the Epworth Sleepiness Scale in clinical trial settings. J Sleep Res. 2022;31(2):e13476.