John Harsh, PhD: Interim Results Show Once-Nightly ON-SXB Dose is Preferred by Patients


Patients participating in the open-label extension trial had a few months for titration, more than 24 months for stable dosing, and a one-week follow up.

The efficacy and safety of once-nightly sodium oxybate, also known as ON-SXB or FT218, for treating adults with narcolepsy was demonstrated in the pivotal phase 3 REST-ON trial. The trial evaluated an investigational extended-release formulation of the therapy and successfully met its coprimary endpoints.

In addition to the groundbreaking phase 3 data, the interim findings from the ongoing RESTORE trial were presented by John Harsh, PhD, Clinical Research Director, Comprehensive Care for Sleep Disorders, Colorado Sleep Institute, at SLEEP 2023 in Indianapolis, IN.

The open-label, switch study evaluated patient preferences regarding both once-nightly and twice-nightly doses of sodium oxybate as well as further examining the safety and efficacy profiles.

Out of 78 patients who completed preference questionnaires, 73 (93.6%) expressed a preference for the once-nightly dosing regimen of sodium oxybate indicating the convenience and simplicity of taking the medication once a night was highly favored by the majority.

"With twice-nightly, patients were missing their second dose at least once in a while, and the consequences were notable," Harsh said in an interview with HCPLive.

Results from RESTORE were derived from an analysis of 180 patients, including REST-ON trial patients (n = 15, 8.3%), oxybate-naive individuals (n = 35, 19.4%), and switch patients (n = 130, 72.2%). Most of the patients were white (83.3%) and female (67.8%), with a mean age of 35 years ranging from 16 - 84.

"All these participants in the open-label extension had a couple of months for titration, 24 months or more for stable dosing, and then one week follow up," he explained. "We were able to collect data on adverse events, adverse drug reactions, get some idea of patient preference and patient experiences and especially in relation to the second night dosing for the twice nightly (sodium oxybate)."


  1. Stern T, Roy A, Shapiro C, et al. 0579 Long-Term Safety of Once-Nightly Oxybate for Narcolepsy: RESTORE Study Interim Analysis of Data. SLEEP. 2023;46(Supplement_1):A254-A255.
  2. Roy A, Harsh J, Ajayi A, Stern T, Dubow J, Gudeman J. 0581 Patient Preferences and Nocturnal Experiences With Oxybate Therapy for Narcolepsy: RESTORE Study Interim Analysis. SLEEP. 2023;46(Supplement_1):A255-A256.
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