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Abstract Details

Once-nightly Sodium Oxybate Improves Symptoms in People With Narcolepsy: Interim Results From the Real-world REFRESH Study
Sleep
P6 - Poster Session 6 (5:00 PM-6:00 PM)
14-007

To report interim results from REFRESH (NCT06792708), a real-world study of once-nightly sodium oxybate (ON-SXB) for narcolepsy. 

ON-SXB (LUMRYZ™) is approved to treat excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy. 
REFRESH enrolled adults with narcolepsy who switched from current twice-nightly oxybates (TN-OXB; switch), had previously used TN-OXB, or were oxybate-naive. ON-SXB was titrated in 1.5-g increments weekly or more gradually, based on efficacy and tolerability, up to 9 g. Participants completed the Epworth Sleepiness Scale (ESS), Narcolepsy Severity Scale (NSS), and Sheehan Disability Scale (SDS) monthly for 4 months. Patient and Clinician Global Impression of Change (PGI-C; CGI-C) scales were completed at end-of-study visit (EOS). Adverse drug reactions (ADRs; ie, study drug-related adverse events) were reported.
As of 7/29/2025, 86 participants were screened; 71 initiated ON-SXB treatment (current TN-OXB use, 35.2%; prior TN-OXB use, 14.1%; oxybate-naive, 50.7%; NT1, 38.0%; NT2, 62.0%); month 4 data were available for 51 participants. Respective mean (SD) ESS scores for switch and non-switch participants were 10.4 (5.4) and 14.9 (4.6) at baseline and 6.3 (3.9) and 8.5 (4.6) at month 4. Respective mean (SD) NSS total scores for switch and non-switch participants were 16.0 (8.1) and 24.4 (9.8) at baseline and 9.8 (9.0) and 14.0 (9.1) at month 4. Respective mean (SD) SDS scores for work/school, social life, and family life/home domains for the overall population were 5.5 (2.9), 5.9 (2.7), and 6.1 (2.8) at baseline and 3.3 (2.6), 3.5 (2.7), and 3.5 (2.8) at month 4. At EOS, 70.0% of switch and 90.4% of non-switch participants were improved on PGI-C; 76.2% of switch and 86.7% of non-switch participants were improved on CGI-C. ADRs were consistent with known oxybate ADRs.
Participants experienced improvements in narcolepsy symptoms with ON-SXB, regardless of prior oxybate use. Final REFRESH results will be presented. 
Authors/Disclosures
Nicole Giudici
PRESENTER 		Ms. Giudici has received personal compensation for serving as an employee of Avadel Pharmaceuticals.
Sarah D. Meskill, MD An immediate family member of Dr. Meskill has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Avadel. An immediate family member of Dr. Meskill has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Jazz. An immediate family member of Dr. Meskill has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Harmony. An immediate family member of Dr. Meskill has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. An immediate family member of Dr. Meskill has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Axsome. Dr. Meskill has stock in Avadel.
Gerard Meskill, MD (Tricoastal Narcolepsy and Sleep Disorders Center) Dr. Meskill has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome Therapeutics. Dr. Meskill has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaeuticals. Dr. Meskill has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Harmony Biosciences. Dr. Meskill has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Harmony Biosciences. Dr. Meskill has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Avadel Pharmaceuticals. Dr. Meskill has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Axsome Therapeutics. Dr. Meskill has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Jazz Pharmaceuticals. Dr. Meskill has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Harmony Biosciences. Dr. Meskill has received research support from Jazz Pharmaceuticals. Dr. Meskill has received research support from Avadel Pharmaceuticals. Dr. Meskill has received research support from Alkermes 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.
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 .
Robyn Porpiglio, NP Mrs. Porpiglio has nothing to disclose.
Oktai Mamedov, MD Dr. Mamedov has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Avadel. The institution of Dr. Mamedov has received research support from Avadel.
Sally Ibrahim, MD The institution of Dr. Ibrahim has received research support from Jazz Pharmaceuticals. The institution of Dr. Ibrahim has received research support from Avadel Pharmaceuticals. The institution of Dr. Ibrahim has received research support from Harmony. The institution of Dr. Ibrahim has received research support from NIH.
Omavi F. Bailey, MD The institution of Dr. Bailey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. The institution of Dr. Bailey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. The institution of Dr. Bailey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novo Nordisk. The institution of Dr. Bailey has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Idorsia . The institution of Dr. Bailey has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Harmony Biosciences. The institution of Dr. Bailey has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eli Lilly. The institution of Dr. Bailey has received research support from Centessa. The institution of Dr. Bailey has received research support from Avadel. The institution of Dr. Bailey has received research support from Neteera .
Richard K. Bogan, MD (SleepMed) Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceutical . Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome . Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Harmony. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Jazz. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Axsome. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Jazz. The institution of Dr. Bogan has received research support from Jazz Pharmaceuticals. The institution of Dr. Bogan has received research support from Harmony . The institution of Dr. Bogan has received research support from Eisai. The institution of Dr. Bogan has received research support from Avadel. The institution of Dr. Bogan has received research support from Takeda. The institution of Dr. Bogan has received research support from Suven. The institution of Dr. Bogan has received research support from Axsome. The institution of Dr. Bogan has received research support from Merck. The institution of Dr. Bogan has received research support from Liva Nova. The institution of Dr. Bogan has received research support from Nyxoah. Dr. Bogan has received research support from Bayer. Dr. Bogan has received intellectual property interests from a discovery or technology relating to health care.
Laura B. Herpel, MD Dr. Herpel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome. Dr. Herpel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Avadel. Dr. Herpel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceuticals. Dr. Herpel has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Harmony. Dr. Herpel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Avadel. Dr. Herpel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Fisher & Paykel. Dr. Herpel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Idorsia. Dr. Herpel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli Lilly. The institution of Dr. Herpel has received research support from Axsome. The institution of Dr. Herpel has received research support from Avadel. The institution of Dr. Herpel has received research support from Centessa. The institution of Dr. Herpel has received research support from Elsai. The institution of Dr. Herpel has received research support from Harmony. The institution of Dr. Herpel has received research support from Idorsia. The institution of Dr. Herpel has received research support from Liva Nova. The institution of Dr. Herpel has received research support from Merck. The institution of Dr. Herpel has received research support from Jazz Pharmaceuticals. The institution of Dr. Herpel has received research support from Takeda. The institution of Dr. Herpel has received research support from Vanda. The institution of Dr. Herpel has received research support from Alkermes.
jeremy mcconnell, MD The institution of Dr. mcconnell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avadel. The institution of Dr. mcconnell has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Inspire. The institution of Dr. mcconnell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz . The institution of Dr. mcconnell has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Nyxoah. The institution of Dr. mcconnell has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. The institution of Dr. mcconnell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novo Nordisk. The institution of Dr. mcconnell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome. The institution of Dr. mcconnell has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Zoll. The institution of Dr. mcconnell has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Avadel. The institution of Dr. mcconnell has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Harmony. The institution of Dr. mcconnell has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eli Lilly. The institution of Dr. mcconnell has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novo Nordisk. The institution of Dr. mcconnell has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Axsome. The institution of Dr. mcconnell has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Idorsia. Dr. mcconnell has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Florida Obesity Society. The institution of Dr. mcconnell has received research support from Avadel . The institution of Dr. mcconnell has received research support from Inspire .
Gretchen S. Richards, MS Ms. Richards has received personal compensation for serving as an employee of Avadel. Ms. Richards has stock in Avadel.
Brian Abaluck, MD Dr. Abaluck has received personal compensation for serving as an employee of Avadel Pharmaceuticals.
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.