{"id":32,"date":"2024-10-06T05:40:40","date_gmt":"2024-10-06T05:40:40","guid":{"rendered":"https:\/\/canisleep.com\/?p=32"},"modified":"2024-10-07T04:54:34","modified_gmt":"2024-10-07T04:54:34","slug":"lumryz-reduces-narcolepsy-symptoms-regardless-of-use-of-alerting-drugs","status":"publish","type":"post","link":"https:\/\/canisleep.com\/index.php\/2024\/10\/06\/lumryz-reduces-narcolepsy-symptoms-regardless-of-use-of-alerting-drugs\/","title":{"rendered":"Lumryz Reduces Narcolepsy Symptoms, Regardless of Use of Alerting Drugs"},"content":{"rendered":"\n

\u00a0<\/p>\n\n\n\n

\"Lumryz<\/figure>\n\n\n\n

A post-hoc analysis confirmed the efficacy of Lumryz in study participants who were and were not using a stable dose of an alerting agent.<\/h1>\n\n\n\n
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Summary: <\/strong>A post-hoc analysis of the phase 3 REST-ON trial demonstrated that Lumryz (sodium oxybate) improves narcolepsy symptoms, including wakefulness, cataplexy episodes, and daytime sleepiness, regardless of whether patients were also using alerting medications. Both groups\u2014those taking and not taking alerting agents\u2014experienced clinically meaningful improvements. The study highlights Lumryz\u2019s potential as an effective treatment for narcolepsy, even in patients who are already using stimulant or wake-promoting drugs.<\/p>\n\n\n\n

Three Key Takeaways:<\/strong><\/p>\n\n\n\n

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  1. Efficacy Regardless of Other Medications:<\/strong>\u00a0Lumryz improved narcolepsy symptoms, including daytime sleepiness and cataplexy, regardless of whether patients were using alerting agents like stimulants.<\/li>\n\n\n\n
  2. Symptom Improvement:<\/strong>\u00a0Patients saw meaningful improvements in wakefulness, overall condition, and number of weekly cataplexy episodes, with significant changes in the Maintenance of Wakefulness Test and Epworth Sleepiness Scale scores.<\/li>\n\n\n\n
  3. Potential as Monotherapy:<\/strong>\u00a0For 37% of patients not taking alerting agents, the analysis suggests that Lumryz monotherapy may be sufficient to manage narcolepsy symptoms effectively.<\/li>\n<\/ol>\n\n\n\n
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    Avadel Pharmaceuticals plc announced the publication of results of a post-hoc analysis from the completed pivotal phase 3 REST-ON clinical trial, which 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. <\/p>\n\n\n\n

    The paper was published online in Sleep Medicine<\/em><\/a>.<\/p>\n\n\n\n

    \u201cTreatment of narcolepsy often requires multiple medicines to adequately control symptoms. Alerting agents, including stimulants<\/a> and wake-promoting agents, are often the first treatment prescribed for narcolepsy,\u201d says Richard K. Bogan<\/a>, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine and Medical University of South Carolina in Charleston, in a release. <\/p>\n\n\n\n

    Bogan continues, \u201cIn 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 (MWT). 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.\u201d<\/p>\n\n\n\n

    <\/p>\n\n\n\n

    The randomized, double-blind, placebo-controlled, pivotal phase 3 REST-ON trial evaluated once-at-bedtime Lumryz in adults with narcolepsy. Primary endpoints included change from baseline in mean sleep latency on the MWT, Clinical Global Impression-Improvement (CGI-I) rating, and number of weekly cataplexy episodes. Secondary endpoint was change from baseline in the Epworth Sleepiness Scale (ESS) score.<\/p>\n\n\n\n

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

    Study Results<\/h2>\n\n\n\n

    Results of the post-hoc analysis:<\/p>\n\n\n\n