Publication of data highlighting efficacy of Lurmyz (sodium oxybate) extended-release oral suspension in improving narcolepsy symptoms regardless of concomitant use of an alerting agent

Results demonstrated clinically significant improvements from baseline in wakefulness, overall condition, number of weekly cataplexy episodes, and excessive daytime sleepiness in patients taking  Lumryz (sodium oxybate) compared to those taking placebo, regardless of concomitant use of alerting agents. The paper, titled “Efficacy of Once-Nightly Sodium Oxybate (FT218) on Daytime Symptoms in Individuals With Narcolepsy With or Without Concomitant Alerting Agent Use: A Post Hoc Analysis From the Phase III REST-ON Trial,” was published online in Sleep Medicine.

"Treatment of narcolepsy often requires multiple medicines to adequately control symptoms. Alerting agents, including stimulants and wake-promoting agents, are often the first treatment prescribed for narcolepsy,” said Richard K. Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine and Medical University of South Carolina in Charleston. “In REST-ON, subjects in the alerting agent subgroup were also pathologically sleepy at baseline and could only remain awake for approximately five minutes during the maintenance of wakefulness test. Both subgroups had marked improvement on daytime sleepiness with once-at-bedtime Lumryz. While this would be expected clinically, this type of post-hoc analysis has not been previously undertaken to evaluate the addition of an oxybate to a stable alerting agent regimen.”

Dauvilliers et al. evaluated the efficacy of Lumryz on  the endpoints in participants with narcolepsy who were taking and not taking alerting agents (modafinil, armodafinil, various amphetamines, dexamphetamine sulfate and methylphenidate hydrochloride). A total of 119 study participants (63%) were taking alerting agents and 71 (37%) were not.

Results of the post-hoc analysis :  i.  Significant improvements with Lumryz at all doses were seen versus placebo for MWT, CGI-I and number of weekly cataplexy episodes (p<0.05) regardless of alerting agent use, which were also clinically meaningful. ii.  Similarly, ESS (Epworth Sleepiness Scale) was significantly improved with Lumryz  at all doses versus placebo in the group taking alerting agents (p<0.05), with significant improvements for the non-alerting agent group at the 7.5 g and 9 g dose, and directional improvement at Week 3 with the 6 g dose.

“It is important for clinicians and people with narcolepsy to recognize that alerting agents alone may not be sufficient to treat excessive daytime sleepiness. As with other oxybates trials, a high proportion of subjects were on stable doses of alerting agents, yet still qualified for study entry based upon pathological sleepiness,” said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs at Avadel. “These data should help initiate discussions between patients and clinicians to assess whether an alerting agent regimen alone is sufficiently managing their narcolepsy. Additionally, for the 37% of participants not on alerting agents, these results show that Lumryz monotherapy may be sufficient to manage narcolepsy symptoms.”

Citation::"Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phaseIII REST-ON trial."Yves Dauvilliers , Thomas Roth , Richard Bogan , Michael J. Thorpy et al., Sleep Medicine. Volume 124, December 2024, Pages 209- 216.https://doi.org/10.1016/j.sleep.2024.09.024.