Lauren, a real patient with narcolepsy on LUMRYZ, feeling more awake in the morning with friends
Lauren was compensated by Alkermes. Individual results may vary.
Extended-release LUMRYZ offers proven daytime efficacy1,2
In a phase 3 pivotal trial, statistically significant results (P<0.001) were demonstrated at every timepoint, dose, and coprimary endpoint evaluated, with efficacy shown as early as Week 31,2
At Week 13 on the 9 g dose:
1.5x the amount of wake time vs placebo—3x more wake time vs baseline2
73% of participants were rated by a clinician as “much” or “very much” improved1
Weekly cataplexy attacks decreased by 57% vs baseline2
Less likely to doze during routine daytime situations vs placebo
Study design2:
Phase 3, double-blind, placebo-controlled, 2-arm, multicenter, randomized clinical trial. Results measured at Weeks 3, 8, and 13 on the 6 g, 7.5 g, and 9 g doses of LUMRYZ in a clinical trial.
Participants2:
212 people with narcolepsy:
- 107 treated with LUMRYZ
- 105 treated with placebo
Coprimary endpoints2:
- Change from baseline in mean sleep latency on the Maintenance Wakefulness Test
- Scores from the Clinical Global Impression-Improvement assessment
- Mean weekly number of cataplexy attacks
Key inclusion criteria2:
- Age ≥16 years
- Diagnosed with NT1 or NT2 according to ICSD-3 criteria
- MSL <11 minutes on the MWT following baseline polysomnography
- ESS score >10
- For participants with NT1: Minimum average of ≥8 cataplexy attacks per week during the screening and baseline period
Key exclusion criteria2:
- Other sleep disorders known to cause excessive daytime sleepiness, including moderate or severe sleep apnea (AHI ≥15 or AHI <15 requiring CPAP)
- Clinically significant or unstable medical or psychiatric conditions
- History of suicidal ideation or drug/alcohol abuse
- Uncontrolled hypertension
- Conditions that could increase the risk of respiratory or central nervous system depression
Maintenance of Wakefulness Test (MWT)
Used to measure sleep latency
An assessment immediately following overnight polysomnogram (PSG), where a person is given 5 opportunities to nap for 20 to 40 minutes every 2 hours during normal wake time with the goal of staying awake as long as possible.
Clinical Global Impression-Improvement Scale (CGI-I)
Used to establish a baseline and track disease severity
A 1-item, 7-point Likert scale that requires a clinician to assess how much the patient’s illness has improved or worsened relative to an established baseline severity on the Clinical Global Impression-Severity Scale (CGI-S).
Epworth Sleepiness Scale (ESS)
Used to help a healthcare provider learn more about how excessive daytime sleepiness (EDS) affects a patient
A self-assessment tool in which a patient reviews 8 situations focusing on common scenarios or activities, and rates how likely they are to doze off in each situation. Each situation is rated on a 4-point scale, ranging from 0 (would never doze off) to 3 (high risk of dozing off).
At Week 13 (9 g),
Patients taking extended-release LUMRYZ had 1.5x the amount of wake time vs placebo—3x more wake time vs baseline1,2
Significant improvements were seen as early as Week 3 (with a 6 g dose)1,2*
Coprimary Endpoint: MWT mean change from baseline in minutes1,2
Treatment with LUMRYZ at 9 g provided over 3x more wake time vs baseline.2
- *At Week 3, all patients were on a 6 g dose before being titrated up to 7.5 g and then 9 g.1,2
At Week 13 (9 g),
73% of patients on LUMRYZ were rated by a clinician as “much” or “very much improved”1
Significant improvements were seen as early as Week 3 (with a 6 g dose)2†
Coprimary Endpoint: Investigator-assessed rating of “much improved” or “very much improved” CGI-I1
Patients who started as “markedly impaired” had significant improvements on extended-release LUMRYZ (P<0.001)1,2
- The data shown are based on FDA calculations in the prescribing information, not the calculations of the original researchers.1,2
- †At Week 3, all patients were on a 6 g dose before being titrated up to 7.5 g and then 9 g.1,2
- ‡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.1
At Week 13 (9 g),
Extended-release LUMRYZ reduced weekly cataplexy attacks by 57%1,2
Significant improvements were seen as early as Week 3 (with a 6 g dose)1
Coprimary Endpoint: Mean change in number of cataplexy attacks from baseline1,2
Weekly cataplexy attacks decreased by 57% for patients on LUMRYZ at Week 13 (9g).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.1,2
- §At Week 3, all patients were on a 6 g dose before being titrated up to 7.5 g and then 9 g.1,2
At Week 13 (9 g),
Patients taking extended-release LUMRYZ were less likely to doze during routine daytime situations vs placebo2,3
Significant improvements were seen as early as Week 3 (with a 6 g dose)2||
Secondary Endpoint: LSM change from baseline ESS score2
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.2-4
- This post hoc analysis was exploratory and not powered to determine statistical significance.
- ||At Week 3, all patients were on a 6 g dose before being titrated up to 7.5 g and then 9 g.1,2
At Week 13 (9 g),
Patients taking extended-release LUMRYZ had 1.5x the amount of wake time vs placebo—3x more wake time vs baseline1,2
Significant improvements were seen as early as Week 3 (with a 6 g dose)1,2*
Coprimary Endpoint: MWT mean change from baseline in minutes1,2
Treatment with LUMRYZ at 9 g provided over 3x more wake time vs baseline.2
- *At Week 3, all patients were on a 6 g dose before being titrated up to 7.5 g and then 9 g.1,2
At Week 13 (9 g),
73% of patients on LUMRYZ were rated by a clinician as “much” or “very much improved”1
Significant improvements were seen as early as Week 3 (with a 6 g dose)2†
Coprimary Endpoint: Investigator-assessed rating of “much improved” or “very much improved” CGI-I1
Patients who started as “markedly impaired” had significant improvements on extended-release LUMRYZ (P<0.001)1,2
- The data shown are based on FDA calculations in the prescribing information, not the calculations of the original researchers.1,2
- †At Week 3, all patients were on a 6 g dose before being titrated up to 7.5 g and then 9 g.1,2
- ‡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.1
At Week 13 (9 g),
Extended-release LUMRYZ reduced weekly cataplexy attacks by 57%1,2
Significant improvements were seen as early as Week 3 (with a 6 g dose)1
Coprimary Endpoint: Mean change in number of cataplexy attacks from baseline1,2
Weekly cataplexy attacks decreased by 57% for patients on LUMRYZ at Week 13 (9g).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.1,2
- §At Week 3, all patients were on a 6 g dose before being titrated up to 7.5 g and then 9 g.1,2
At Week 13 (9 g),
Patients taking extended-release LUMRYZ were less likely to doze during routine daytime situations vs placebo2,3
Significant improvements were seen as early as Week 3 (with a 6 g dose)2||
Secondary Endpoint: LSM change from baseline ESS score2
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.2-4
- This post hoc analysis was exploratory and not powered to determine statistical significance.
- ||At Week 3, all patients were on a 6 g dose before being titrated up to 7.5 g and then 9 g.1,2
Because I am less sleepy during the day and my cataplexy is more controlled, I feel more comfortable making travel plans with my friends.”
–Lauren
Learn about LUMRYZ in a real-world setting
Lauren was compensated by Alkermes. Individual results may vary.
AHI, apnea-hypopnea index; CGI-I, Clinical Global Impression-Improvement; CGI-S, Clinical Global Impression-Severity; CPAP, continuous positive airway pressure; ESS, Epworth Sleepiness Scale; FDA, Food and Drug Administration; ICSD-3, International Classification of Sleep Disorders, Third Edition; LSM, least squares mean; MSL, mean sleep latency; MWT, Maintenance of Wakefulness Test; NT1, narcolepsy type 1; NT2, narcolepsy type 2; SD, standard deviation; SE, standard error.
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. 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. 4. Avadel, Data on file.
