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Abstract Introduction Until recently, the only available oxybate therapy options were immediate-release (IR) formulations requiring patients to awaken 2.5 to 4 hours after their first dose to take a second dose. Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) is an extended-release formulation of sodium oxybate that eliminates the need for a middle-of-the-night dose. RESTORE (NCT04451668) was an open-label/switch study that evaluated the 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 to capture their experience with ON-SXB. Results As of November 2023, EOS questionnaire data were available for 89 participants, including 21 participants who completed REST-ON or were oxybate naive and 68 participants who switched from IR oxybate to ON-SXB. In total, 71% (63/89) of responders rated their narcolepsy “much better” or “somewhat better” after initiating ON-SXB. After starting ON-SXB, 75% (67/89) were very satisfied with ON-SXB compared to other treatments they had taken, and 89% (79/89) would recommend ON-SXB to a family member or friend with narcolepsy. Approximately 69% (61/89) of participants found it easier to go through the day without falling asleep, 91% (81/89) were better able to sleep through the night, 64% (57/89) were able to get more done at work or school, and 64% (57/89) were better able to socialize with friends or family. Additionally, 43% (38/89) of responders were able to perform or better perform certain daily activities. Of the participants who switched from IR oxybate to ON-SXB, 91% (62/68) were better able to follow the recommended dosing schedule of ON-SXB. Conclusion These EOS RESTORE data show a high level of satisfaction with ON-SXB, improved symptom control, and a preference for ON-SXB over other treatment options. A majority switching from IR oxybate treatment reported improvement in dosing as directed. Support (if any) Avadel Pharmaceuticals
Ajayi et al. (Sat,) studied this question.