0766 Real-World Experience of Once-Nightly Sodium Oxybate Treatment in People with Narcolepsy: Final Results from REFRESH

Abstract Introduction Oxybate treatment improves quality of life (QOL) for people with narcolepsy; however, the middle-of-the-night dose required with twice-nightly oxybates (TN-OXB) can be burdensome. Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) is approved to treat cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. REFRESH (NCT06792708) is a prospective, real-world study that assessed ON-SXB treatment for narcolepsy. Methods Adults with narcolepsy who switched from current TN-OXB (switch participants), or had prior TN-OXB use or were oxybate-naive (not-oxybate-treated) received ON-SXB titrated in 1.5-g increments weekly or more gradually, based on efficacy/tolerability, up to 9 g/night. At baseline and end of study (EOS), all participants completed a 7-question survey about their QOL and narcolepsy symptoms. Switch participants completed a baseline survey about their TN-OXB treatment experience. All participants completed an EOS questionnaire about their ON-SXB treatment experience. Results In total, 71 participants initiated ON-SXB (switch, n=25 35%; prior TN-OXB use, n=10 14%; oxybate-naive, n=36 51%). Mean (SD) QOL (0=“worst possible,” 10=“best possible”) was 5.9 (1.3) and 5.2 (1.5) at baseline to 7.6 (1.4) and 6.9 (1.4) at EOS for switch (n=20) and not-oxybate-treated (n=34) participants, respectively. Mean (SD) fatigue (0=“never fatigued,” 10=“extremely fatigued”) was 6.3 (1.7) and 8.0 (1.6) at baseline to 4.3 (2.3) and 5.1 (2.1) at EOS for switch (n=20) and not-oxybate-treated (n=34) participants, respectively. Most switch participants (92% 23/25) found the second TN-OXB dose burdensome. At EOS (n=54), narcolepsy was “somewhat” or “much” better with ON-SXB (switch, 70%; not-oxybate-treated, 91%). Participants reported not falling asleep during the day (switch, 55%; not-oxybate-treated, 68%), sleeping through the night (switch, 65%; not-oxybate-treated, 85%), getting more done at work/school (switch, 40%; not-oxybate-treated, 62%), improved socialization (switch, 55%; not-oxybate-treated, 71%), and less drowsy driving among those who had previously experienced drowsy driving (switch, 100% 8/8; not-oxybate-treated, 90% 19/21). 75% (15/20) of switch participants preferred ON-SXB to TN-OXB; 10% were not sure or had no opinion. 80% (16/20) of switch participants reported better adherence to once-nightly dosing. Conclusion These real-world data demonstrate that ON-SXB treatment improved narcolepsy symptoms and QOL for both switch and not-oxybate-treated patients. The majority of switch participants preferred ON-SXB to TN-OXB. Support (if any) Avadel Pharmaceuticals