Abstract Details

Title A Long-Term Study of the Safety and Maintenance of Efficacy of Solriamfetol (JZP-110) for Treatment of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

Topic Sleep

Presentation(s) S46 - Sleep Science and Therapy Updates (2:17 PM-2:28 PM)

Poster/Presentation
Number 008

Background

In placebo-controlled studies, solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor, has been shown to be effective in treating excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea (OSA).

Objective Evaluation of long-term safety and maintenance of efficacy of solriamfetol.

Design/Methods

Participants with narcolepsy or OSA who had completed prior studies of solriamfetol were eligible. This study included a 2-week titration followed by a maintenance phase of up to 50 weeks. After 6 months of treatment, a subgroup entered a 2-week placebo-controlled Randomized Withdrawal (RW) phase with change in Epworth Sleepiness Scale (ESS) score from beginning to end of the phase as the primary endpoint, and Patient and Clinician Global Impression of Change (PGI-C and CGI-C, respectively) as secondary endpoints. Open-label efficacy was assessed by ESS, PGI-C, and CGI-C; missing data were imputed using a last-observation-carried-forward approach.

Results There were 643 participants (226 narcolepsy; 417 OSA) in the safety population; the efficacy population in the RW phase included 280 participants (141 placebo; 139 solriamfetol). In the open-label phase of up to 1 year, participants treated with solriamfetol demonstrated sustained reductions in mean ESS scores and improvements on the PGI-C and CGI-C. In the RW phase, least-squares mean change on ESS was 1.6 in participants who continued solriamfetol and 5.3 in participants switched to placebo (P<0.0001). For both secondary endpoints, greater percentages of participants randomized to placebo were reported as worse at the end of the RW phase versus solriamfetol (both P<0.0001). Common adverse events (AEs; ≥5%) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4.2%) participants had ≥1 serious AE.

Conclusions

Solriamfetol demonstrated long-term maintenance of efficacy in the treatment of EDS associated with narcolepsy or OSA. The safety profile was consistent with placebo-controlled studies of solriamfetol.

Support: Jazz Pharmaceuticals.

Authors/Disclosures
Nancy R. Foldvary-Schaefer, DO, FAAN (Cleveland Clinic) PRESENTER	Dr. Foldvary-Schaefer 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. The institution of Dr. Foldvary-Schaefer has received research support from Jazz. The institution of Dr. Foldvary-Schaefer has received research support from Suven. The institution of Dr. Foldvary-Schaefer has received research support from Takeda. Dr. Foldvary-Schaefer has received publishing royalties from a publication relating to health care. Dr. Foldvary-Schaefer has received publishing royalties from a publication relating to health care.
	No disclosure on file
Richard Schwab, MD (University of Pennsylvania Medical Center)	No disclosure on file
Jean-Louis Pepin	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Geert K. Mayer, MD, PhD (Philipps-Universität Marburg)	Dr. Mayer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen, Idorsia, NLS Pharma. Dr. Mayer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia, Takeda. Dr. Mayer has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Idorsia.
	No disclosure on file
Michelle Baladi, PhD (Jazz Pharmaceuticals)	Dr. Baladi has stock in Jazz Pharmaceuticals .
Patricia Chandler	No disclosure on file
	No disclosure on file
	No disclosure on file

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