page-decoration REQUEST A REPRESENTATIVE

Across all 3 endpoints, at all 3 doses, and as early as week 3,

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

In a post hoc analysis, improvements in MWT, CGI-I, and ESS were similar in subgroups of participants (LUMRYZ vs placebo).* Improvements were consistent in participants with or without concomitant alerting agents.3†

These post hoc analyses were exploratory and not powered to determine statistical significance.

Co-primary endpoints2

MWT CGI-I Mean change in weekly cataplexy attacks

Select secondary endpoint2

ESS

REST-ON Study Design

Defining Measurements

*Not all results/improvements were statistically significant.

†Concomitant alerting agents included modafinil, armodafinil, dextroamphetamine, mixed amphetamine salts, lisdexamfetamine, and methylphenidate.

Patients taking once-at-bedtime LUMRYZ had 1.5x 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 minutes1,2

MWT Change in sleep latency from baseline

Graph showing that in the REST-ON trial, patients taking LUMRYZ had 1.5x the amount of wake time vs patients taking placebo, and significant improvements were seen as early as week 3 Graph showing that in the REST-ON trial, patients taking LUMRYZ had 1.5x the amount of wake time vs patients taking placebo, and significant improvements were seen as early as week 3

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

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

Graph showing that in the REST-ON trial, 73% of patients on LUMRYZ were rated by a clinician as ‘much’ or ‘very much’ improved at 13 weeks compared to patients on placebo Graph showing that in the REST-ON trial, 73% of patients on LUMRYZ were rated by a clinician as ‘much’ or ‘very much’ improved at 13 weeks compared to patients on placebo
73% 73% icon
of patients on LUMRYZ were rated by a clinician as “much” or “very much improved” at week 13.1¶

The data shown are based on FDA calculations in the prescribing information, not the calculations of the original researchers.1

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

||Baseline means were calculated using the CGI-S scale, which is designed to measure disease severity. Endpoint means were calculated using the CGI-I scale, which is designed to measure changes from a baseline severity score.

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

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

Graph showing that in the REST-ON trial, once-at-bedtime LUMRYZ decreased weekly cataplexy attacks by 57% for patients at week 13 vs placebo Graph showing that in the REST-ON trial, once-at-bedtime LUMRYZ decreased weekly cataplexy attacks by 57% for patients at week 13 vs placebo
57% 57% icon
Weekly cataplexy attacks decreased by 57% for patients on LUMRYZ at week 13.2

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

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

Patients taking once-at-bedtime LUMRYZ were less likely to doze during activities of daily living vs placebo1,2,4

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

Graph showing the change in ESS score from baseline, where half of patients on LUMRYZ scored within the range of normal daytime sleepiness vs patients on placebo Graph showing the change in ESS score from baseline, where half of patients on LUMRYZ scored within the range of normal daytime sleepiness vs patients on placebo
9.5 9.5% icon
In a post hoc analysis,
the median ESS score was 9.5 at the 9-g dose (week 13).
Half of the participants on LUMRYZ scored within the range of normal daytime sleepiness.3,4‡‡
This post hoc analysis was exploratory and not powered to determine statistical significance.
Do you use the ESS in your practice? If so, what do your patients typically score?

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

‡‡The median ESS score of LUMRYZ participants were: 14 at 6 g at week 3, 12 at 7.5 g at week 8, 9.5 at 9 g at week 13.

BMI, body mass index; CGI-I, Clinical Global Impression-Improvement; CGI-S, Clinical Global Impression-Severity; EDS, excessive daytime sleepiness; ESS, Epworth Sleepiness Scale; LSM, least squares mean; MWT, Maintenance of Wakefulness Test; NT1, narcolepsy type 1; NT2, narcolepsy type 2; SD, standard deviation; SE, standard error.

References:

  1. References: 1. LUMRYZ™ (sodium oxybate for extended-release oral suspension). Prescribing Information. Chesterfield, MO: Avadel Pharmaceuticals. 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. Avadel, Data on file. 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.