Abstract Details

Title Patient Preference and Nocturnal Experience With Sodium Oxybate Treatment for Narcolepsy: Interim Data From RESTORE

Topic Sleep

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 470

Objective To assess patient preference for once-nightly sodium oxybate (ON-SXB; FT218) versus twice-nightly SXB and experiences with the second nightly SXB dose in patients who switched from twice-nightly SXB to ON-SXB.

Background Immediate-release oxybate formulations to treat narcolepsy symptoms require patients to awaken for a second dose 2.5-4 h after the first. Extended-release ON-SXB eliminates middle-of-the-night dosing.

Design/Methods The ongoing, open-label extension/switch study RESTORE (NCT04451668) enrolled participants age ≥16 y with a confirmed diagnosis of narcolepsy type 1 or 2 from the phase 3 REST-ON clinical trial and eligible participants receiving stable doses of twice-nightly SXB for at least 1 month. Switch patients received initial ON-SXB doses equivalent/closest to their previous total dose of twice-nightly SXB. Switch patients completed patient preference questionnaires 3 months after switching and nocturnal adverse event (AE) questionnaire at baseline.

Results At an interim data cutoff date of September 7, 2021, 35 participants completed patient preference questionnaires; 94.3% (33/35) preferred ON-SXB to twice-nightly SXB. Sixty switch participants completed nocturnal AE questionnaires. Thirty-eight (63%) unintentionally missed their second twice-nightly SXB dose within the past 3 months; of these, 84% indicated that narcolepsy symptoms were worse the next day. Twenty-four participants (40%) had taken their second twice-nightly SXB dose >4 h after the first dose and 42% (10/24) felt somewhat, quite a bit, or extremely groggy or unsteady the next morning. For 73% (44/60), taking a second nighttime dose was somewhat, quite a bit, or extremely inconvenient; 54 (90%) arose from bed after the second dose, 3 reported associated falls, and 2 had injuries. Anxiety and the need for someone else to wake them were reported by 20% and 23%, respectively.

Conclusions

Interim data indicate that patients with narcolepsy prefer ON-SXB to twice-nightly SXB. ON-SXB may ease treatment burdens associated with the second nightly SXB dose.

Authors/Disclosures
Asim Roy, MD (Ohio Sleep Medicine Institute) PRESENTER	Dr. Roy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz Pharma . Dr. Roy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Harmony Bioscience. The institution of Dr. Roy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Inspire. Dr. Roy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Avadel. Dr. Roy has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz Pharma. Dr. Roy has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Harmony biosciences. Dr. Roy has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai . Dr. Roy has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Inspire. The institution of Dr. Roy has received research support from Jazz . The institution of Dr. Roy has received research support from Inspire. The institution of Dr. Roy has received research support from Avadel.
John Harsh, PhD (Alpine Clinical Research Center)	Dr. Harsh has nothing to disclose.
	No disclosure on file
	No disclosure on file
David J. Seiden, MD (David J. Seiden, MD)	Dr. Seiden has received personal compensation for serving as an employee of Avadel Pharmaceuticals. Dr. Seiden has received stock or an ownership interest from Avadel Pharmaceuticals.
Jordan S. Dubow, MD	Dr. Dubow has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revalesio .

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