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Abstract Details

Effects of Once-nightly Sodium Oxybate on Apnea-hypopnea Index: Post Hoc Analysis from the Phase 3 REST -ON Clinical Trial
Sleep
P8 - Poster Session 8 (8:00 AM-9:00 AM)
4-005
This post hoc analysis of REST-ON evaluates the effect of once-nightly sodium oxybate (ON-SXB) compared to placebo on apnea hypopnea index (AHI) in individuals with narcolepsy with either no sleep apnea or mild sleep apnea.
Registrational trials of SXB, a central nervous system depressant used to treat narcolepsy, have generally excluded patients with respiratory depression, including those with an AHI >15.
In the phase 3, double-blind REST-ON (NCT02720744) trial, participants (age ≥16 years) with narcolepsy and AHI <15 were randomized 1:1 to ON-SXB (week 1, 4.5 g; weeks 2–3, 6 g; weeks 4–8, 7.5 g; weeks 9–13, 9 g) or placebo. AHI was measured using polysomnography at baseline and weeks 3, 8, and 13, and analyzed post hoc. Adverse drug reactions (ADRs) were assessed.
Respective mean (min, max) AHI values were similar for the ON-SXB (n=97) and placebo groups (n=93) at baseline (2.7 [0, 15] and 2.8 [0, 13]), week 3 (0.1 [0, 5] and 0.1 [0, 2]), and week 8 (0 [0, 0] and 0 [0, 0]). At week 13, mean (min, max) AHI was 0 (0, 0) and 0.2 (0, 10) in the ON-SXB and placebo groups, respectively. Least squares mean differences (95% CI) in change from baseline in AHI with ON-SXB and placebo were –0.11 (–0.46 to 0.24; P=0.522) at week 3, –0.11 (–0.46 to 0.23; P=0.518) at week 8, and –0.12 (–0.46 to 0.23; P=0.515) at week 13. One (0.9%) and 1 (1.0%) participant in the ON-SXB and placebo arms, respectively, experienced ADRs of sleep apnea, and 1 (0.9%) participant receiving ON-SXB reported snoring; all were mild or moderate in severity.
Treatment with ON-SXB was not associated with worsened AHI at any tested dose. ON-SXB was well-tolerated, as reported respiratory-related ADRs were minimal, and mild or moderate in severity.
Authors/Disclosures
Natalie Batta, MD
PRESENTER 		Dr. Batta has received personal compensation for serving as an employee of Avadel.
Akinyemi Ajayi, MD Dr. Ajayi has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz pharmaceuticals. Dr. Ajayi has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for avadel. Dr. Ajayi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for harmony biosciences. Dr. Ajayi has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for jazz pharmaceuticals. Dr. Ajayi 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 . Dr. Ajayi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for jazz pharmaceuticals. Dr. Ajayi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for avadel. Dr. Ajayi has stock in avadel.
Richard K. Bogan, MD (SleepMed) Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceutical . Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome . Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Harmony. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Jazz. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Axsome. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Jazz. The institution of Dr. Bogan has received research support from Jazz Pharmaceuticals. The institution of Dr. Bogan has received research support from Harmony . The institution of Dr. Bogan has received research support from Eisai. The institution of Dr. Bogan has received research support from Avadel. The institution of Dr. Bogan has received research support from Takeda. The institution of Dr. Bogan has received research support from Suven. The institution of Dr. Bogan has received research support from Axsome. The institution of Dr. Bogan has received research support from Merck. The institution of Dr. Bogan has received research support from Liva Nova. The institution of Dr. Bogan has received research support from Nyxoah. Dr. Bogan has received research support from Bayer. Dr. Bogan has received intellectual property interests from a discovery or technology relating to health care.
Bruce C. Corser, MD Dr. Corser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Axsome. Dr. Corser has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Avadel. The institution of Dr. Corser has received research support from Alkermes, . The institution of Dr. Corser has received research support from Apnimed. The institution of Dr. Corser has received research support from Avadel. The institution of Dr. Corser has received research support from Axsome. The institution of Dr. Corser has received research support from Eisai. The institution of Dr. Corser has received research support from Eli Lilly. The institution of Dr. Corser has received research support from Harmony. The institution of Dr. Corser has received research support from Incannex. The institution of Dr. Corser has received research support from Jazz. The institution of Dr. Corser has received research support from Mineralys. The institution of Dr. Corser has received research support from Suven. The institution of Dr. Corser has received research support from Takeda. The institution of Dr. Corser has received research support from Centessa.
Brian Abaluck, MD Dr. Abaluck has received personal compensation for serving as an employee of Avadel Pharmaceuticals.
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.