Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation (2445)

Objective: To evaluate the efficacy of FT218, a once-nightly sodium oxybate (SO) formulation, on excessive daytime sleepiness (EDS), self-reported sleep quality/refreshing nature of sleep, sleep paralysis (SP), and hypnagogic hallucinations (HH) in patients with narcolepsy. Background: Twice-nightly SO is an effective treatment for EDS and cataplexy in patients with narcolepsy. FT218 is an investigational once-nightly controlled-release formulation of SO. Design/Methods: This was a randomized, double-blind, placebo-controlled, multicenter, parallel-group study in patients with narcolepsy ≥16 years old (randomized, n=212). The 4-period uptitration dosing schedule was as follows: 4.5 g for 1 week, 6 g for 2 weeks, 7.5 g for 5 weeks, and 9 g for 5 weeks (total study duration, 17 weeks). Secondary endpoints included Epworth Sleepiness Scale (ESS), sleep quality/refreshing nature of sleep using a visual analogue scale (VAS), and SP and HH using a sleep symptom diary (SSD). Results: FT218 demonstrated significant (P Conclusions: FT218 demonstrated significant and clinically meaningful results vs placebo at all doses tested for ESS, sleep quality/refreshing nature of sleep, and SP, representing improvement on important narcolepsy symptoms. FT218 was generally well tolerated, and the most common adverse reactions were well-known and established SO adverse reactions. Disclosure: Dr. Thorpy has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz. Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Roth has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Avadel. Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz. Yves Dauvilliers has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for idorsia. Yves Dauvilliers has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for JAZZ. Yves Dauvilliers has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avadel. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Kushida has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for XW Pharma, Inc.. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zephyr Sleep Technologies. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck & Co., Inc.. Dr. Kushida has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for State of Arizona. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Browne George Ross, LLP. The institution of Dr. Kushida has received research support from AmCAD, Philips-Respironics, Asate, Syneos Health, Inspire. Dr. Kushida has received publishing royalties from a publication relating to health care. Colin Shapiro has nothing to disclose. BC Corser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. BC Corser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. BC Corser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Harmony. Akinyemi Ajayi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceutical. Akinyemi Ajayi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz Pharmaceutical. Dr. Dubow has received personal compensation for serving as an employee of Avadel Pharmaceuticals. Dr. Dubow has received stock or an ownership interest from Avadel Pharmaceuticals. Dr. Seiden has received personal compensation for serving as an employee of Avadel Pharmaceuticals. Dr. Seiden has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Physician’s Seal. Dr. Seiden has received stock or an ownership interest from Avadel Pharmaceuticals. Mr. Rosenberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. The institution of Mr. Rosenberg has received research support from Eisai.