0399 Patient Preference and Nocturnal Experience With Sodium Oxybate Treatment for Narcolepsy: Interim Data From RESTORE

Abstract Introduction Available, immediate-release oxybate products for narcolepsy require patients to awaken a second dose 2.5-4 h after the first cover full night of sleep. The investigational, extended-release once-nightly sodium (ON-SXB; FT218) eliminates this middle-of-the-night dosing. This interim analysis from ongoing RESTORE study (NCT04451668) assessed patient preferences ON-SXB versus twice-nightly (SXB) and experiences with nightly SXB in who switched ON-SXB. Methods Participants enrolled open-label extension/switch (RESTORE) were aged ≥16 y confirmed diagnosis type 1 or 2 phase 3 REST-ON trial receiving stable doses ≥1 month. Initial switch equivalent/closest their previous total dose. Patient preference questionnaires completed by months switching nocturnal adverse event (AE) at baseline. Results At an data cutoff date November 22, 2021, 46 participants questionnaires; 93.5% (43/46) preferred SXB. Nocturnal AE 76 participants. In before ON-SXB, 62% (47/76) had unintentionally missed dose, 86% experiencing worse symptoms next day. Forty percent (30/76) reported taking >4 47% reporting being somewhat, quite bit, extremely groggy/unsteady morning. For 76% (58/76), nighttime was inconvenient. Additionally, 91% (69/76) that they arisen bed dose; these, 5 associated falls, injuries. Anxiety (25%) need someone else wake them (21%) also reported. One participant medication missing when awoke Conclusion These indicate individuals prior experience prefer Treatment burden may be alleviated Support (If Any) Avadel Pharmaceuticals