(#64) Patient Preferences of Sodium Oxybate Treatment for Narcolepsy: RESTORE End-of-Study Survey Data

Abstract: Introduction: Immediate-release (IR) oxybates require patients to awaken 2.5 to 4 hours after their first dose for a second dose. Once-nightly sodium oxybate (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 of ON-SXB and surveyed patient preferences for ON-SXB or IR oxybate therapies. 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 ìmuch betterî or ìsomewhat betterî 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. Conclusion: These data demonstrate improved symptom control, high satisfaction, and easier dosing for participants who took ON-SXB, with 89% of participants indicating they would recommend ON-SXB to a family member/friend.Short Description: Once-nightly sodium oxybate (ON-SXB), an extended-release oxybate formulation, eliminates the need for middle-of-the-night dosing. RESTORE was an open-label/switch study evaluating tolerability of ON-SXB that also assessed preferences for ON-SXB or immediate-release oxybates using an end-of-study questionnaire. After ON-SXB initiation, most respondents rated their narcolepsy as better and would recommend ON-SXB. Switch participants were better able to follow the ON-SXB dosing schedule vs the immediate-release oxybate schedule. Findings demonstrated high satisfaction and preference for ON-SXB.Name of Sponsoring Organization(s): Avadel Pharmaceuticals