Patient Preferences of Sodium Oxybate Treatment for Narcolepsy: RESTORE End-of-Study Survey Data
Asim Roy1, J. Douglas Hudson2, Adrian Santamaria3, Brian Abaluck4, Jennifer Gudeman4
1Ohio Sleep Medicine Institute, 2FutureSearch Trials of Neurology, 3Northwest Houston Neurology & Comprehensive Sleep Medicine Center, 4Avadel Pharmaceuticals
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.
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