Abstract Details

Title Consistent Efficacy of Once-nightly Sodium Oxybate Regardless of Patient Demographic and Baseline Disease Characteristics

Topic Sleep

Presentation(s) P10 - Poster Session 10 (11:45 AM-12:45 PM)

Poster/Presentation
Number 9-008

Objective Once-nightly sodium oxybate (ON-SXB; FT218; LUMRYZ™) was investigated in patients with narcolepsy in the phase 3 REST-ON trial (NCT02720744). This post-hoc analysis assessed ON-SXB efficacy across participant subgroups.

Background All tested doses of ON-SXB resulted in significant improvements (all P<0.001) for the coprimary endpoints of change from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) rating of “much” or “very much” improved, weekly number of cataplexy attacks (NCA), and in the secondary endpoint Epworth Sleepiness Scale (ESS) score.

Design/Methods Participants (≥16 years) with narcolepsy type 1 (NT1) or 2 (NT2) were randomized 1:1 to receive ON-SXB (4.5 g [1 week], 6 g [2 weeks], 7.5 g [5 weeks], and 9 g [5 weeks]) or placebo. Least squares mean differences (LSMD [95% CI]) in change from baseline with ON-SXB vs placebo for MWT, NCA, and ESS, and odds ratios (ORs) for CGI-I, across demographic and disease characteristic subgroups were calculated. Data from the modified intent-to-treat (mITT) population (all randomized participants with ≥1 efficacy measure after receiving the 6.0-g dose) were analyzed.

Results The mITT population included 190 participants (ON-SXB, n=97; placebo, n=93). ON-SXB 9 g significantly improved mean sleep latency on the MWT (minutes; P<0.05) for age, sex, race, BMI, narcolepsy type, and alerting agent use subgroups (LSMD range: 4.0 – 10.0). ORs significantly favored ON-SXB 9 g on CGI-I (P<0.05) for low/high age, white/non-white race, alerting agent use, female sex, high BMI, and NT1 (range: 3.3–7.1). ON-SXB 9 g significantly improved NCA (P<0.05) for all subgroups (LSMD range: –5.5 to –7.6) except non-white and male. All subgroups showed significant improvements on ESS score with ON-SXB 9 g except NT2 (LSMD [95% CI]: –2.72 [–6.09, 0.65]).

Conclusions These findings demonstrate the robust efficacy of once-at-bedtime ON-SXB across participant subgroups.

Authors/Disclosures
Michael J. Thorpy, MD (Montefiore Medical Center) PRESENTER	Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avadel. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for alkermes. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Harmony. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for centessa. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Thorpy has received publishing royalties from a publication relating to health care.
Thomas Roth, PhD (Henry Ford Hospital)	Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Roth has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Avadel. Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz.
Clete A. Kushida, MD, PhD (Stanford Sleep Medicine Center)	Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avadel. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Kushida has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for XW Pharma, Inc.. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zephyr Sleep Technologies. Dr. Kushida has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vivos. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerebra. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck & Co., Inc.. Dr. Kushida has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for State of Arizona. Dr. Kushida has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Browne George Ross, LLP. The institution of Dr. Kushida has received research support from AmCAD, Philips-Respironics, Asate, Syneos Health, Inspire. Dr. Kushida has received publishing royalties from a publication relating to health care.
Anne Marie Morse (Geisinger Commonwealth School of Medicine)	No disclosure on file
John Harsh, PhD (Alpine Clinical Research Center)	Dr. Harsh has nothing to disclose.
Luis Ortiz (JHACH)	Luis Ortiz has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avadel. Luis Ortiz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceuticals. Luis Ortiz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Harmony Biosciences. Luis Ortiz has stock in Ascendis Pharma. Luis Ortiz has a non-compensated relationship as a Speaker with Wake Up Narcolepsy that is relevant to AAN interests or activities.
Jordan S. Dubow, MD	Dr. Dubow has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revalesio .
Jennifer Gudeman (Avadel Pharmaceuticals)	Miss Gudeman has received personal compensation for serving as an employee of Avadel Pharmaceuticals. Miss Gudeman has stock in Avadel Pharmaceuticals.
Yves Dauvilliers, MD, PhD (Hopital Gui De Chaulliac)	Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for idorsia. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for JAZZ. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avadel. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alkermes. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Centessa. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bioprojet. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Harmony Bioscience.

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