Once-nightly Sodium Oxybate Improves Symptoms in People With Narcolepsy: Interim Results From the Real-world REFRESH Study
Sarah Meskill1, Gerard Meskill2, Asim Roy3, Adrian Santamaria4, Robyn Porpiglio5, Oktai Mamedov6, Sally Ibrahim7, Omavi Bailey8, Richard Bogan9, Laura B. Herpel10, jeremy mcconnell11, Gretchen S. Richards12, Brian Abaluck12, Jennifer Gudeman12
1Tricoastal Narcolepsy and Sleep Disorder Center, 2Tricoastal Narcolepsy and Sleep Disorders Center, 3Ohio Sleep Medicine Institute, 4NW HOUSTON NEUROLOGY AND COMPREHENSIVE SLEEP, 5Ghaly Sleep Management Services, LLC, 6Comprehensive Sleep Center, 7University Hospitals Cleveland Medical Center, 8Biorhythms, 9University of South Carolina School of Medicine and Medical University of South Carolina, 10Bogan Sleep Consultants, 11Florida Sleep Specialists, 12Avadel Pharmaceuticals
Objective:
To report interim results from REFRESH (NCT06792708), a real-world study of once-nightly sodium oxybate (ON-SXB) for narcolepsy.
Background:
ON-SXB (LUMRYZ™) is approved to treat excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy.
Design/Methods:
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.
Results:
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.
Conclusions:
Participants experienced improvements in narcolepsy symptoms with ON-SXB, regardless of prior oxybate use. Final REFRESH results will be presented.
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