Abstract Details

Title Patient Preferences of Sodium Oxybate Treatment for Narcolepsy: RESTORE End-of-Study Survey Data

Topic Sleep

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 4-008

Objective

To survey the preferences of participants in the RESTORE study for once-nightly sodium oxybate (ON-SXB) or immediate-release (IR) oxybate therapies.

Background IR oxybate formulations require patients to awaken 2.5 to 4 hours after their first dose for a second dose. ON-SXB is an extended-release formulation, eliminating the need for middle-of-the-night dosing. RESTORE (NCT04451668) was an open-label/switch study that evaluated safety and tolerability.

Design/Methods Participants were ≥16 years of age with narcolepsy type 1 or 2 who either completed the phase 3 REST-ON trial and were on stable doses of IR oxybate for ≥1 month or oxybate naive. Participants completed end-of-study (EOS) questionnaires about their experience with ON-SXB.

Results EOS questionnaire data were available for 89 participants (21 completed REST-ON or were oxybate naive; 68 switched from IR oxybate to ON-SXB). Overall, 71% of total responders rated their narcolepsy “much better” or “somewhat better” after initiating ON-SXB. 75% were very satisfied with ON-SXB compared to other treatments, and 89% would recommend ON-SXB to others. Approximately 69% found it easier to go through the day without falling asleep, 91% slept better through the night, 64% were more productive at work/school, and 64% were better able to socialize. Additionally, 43% were able to perform or better perform certain daily activities. Of the 68 switch participants, 91% were better able to follow the dosing schedule of ON-SXB.

Conclusions These data demonstrate high ON-SXB satisfaction, improved symptom control, and a preference for ON-SXB over other therapies, with 89% of participants indicating they would recommend ON-SXB to a family member/friend.

Authors/Disclosures
Brian Abaluck, MD PRESENTER	Dr. Abaluck has received personal compensation for serving as an employee of Avadel Pharmaceuticals.
Asim Roy, MD (Ohio Sleep Medicine Institute)	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 D. Hudson, MD, FAAN	Dr. Hudson has nothing to disclose.
Adrian A. Santamaria, MD (NW HOUSTON NEUROLOGY AND COMPREHENSIVE SLEEP)	Dr. Santamaria has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Avadel,. Dr. Santamaria has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz . Dr. Santamaria has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Avadel. Dr. Santamaria has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Jazz .
Jennifer Gudeman (Avadel Pharmaceuticals)	Miss Gudeman has received personal compensation for serving as an employee of Avadel Pharmaceuticals. Miss Gudeman has stock in Avadel Pharmaceuticals.

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