Pooled Analysis From 12-Week Randomized, Controlled Studies of Solriamfetol in the Treatment of Excessive Daytime Sleepiness in Participants With Obstructive Sleep Apnea or Narcolepsy

Background: Solriamfetol (formerly JZP-110), a dopamine and norepinephrine reuptake inhibitor, has been approved in the US (SunosiTM) to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy (75-150mg/d) or obstructive sleep apnea (OSA [37.5-150mg/d]). Pooled efficacy and safety data from 12-week randomized, double-blind, placebo-controlled studies (2 narcolepsy, 1 OSA) were analyzed.

Methods: Efficacy assessments included Maintenance of Wakefulness Test (MWT) sleep latency (minutes), Epworth Sleepiness Scale (ESS), and Patient Global Impression of Change (PGI-C). Safety was also assessed.

Results: Baseline MWT and ESS assessments reflected greater severity for narcolepsy (n=105 placebo, 215 solriamfetol [combined doses]) compared with OSA (n=113 placebo, 343 solriamfetol). Changes from baseline to week 12 in MWT and ESS reflected dose-related effects. On MWT, least squares (LS) mean differences vs placebo were 2.2, 7.4, and 10.4 for 75, 150, and 300mg in narcolepsy, and 4.7, 9.0, 11.1, and 13.0 for 37.5, 75, 150, and 300mg in OSA. On ESS, LS mean differences were -1.8, -3.8, and -5.2 for 75, 150, and 300mg in narcolepsy, and -2.0, -1.9, -4.5, and -4.8 for 37.5, 75, 150, 300mg in OSA. At week 12, the percentage of participants reporting improvement on PGI-C was increased vs placebo (results similar between disorders). Common (≥5%) AEs (overall population) were headache, nausea, decreased appetite, anxiety, nasopharyngitis, diarrhea, and dry mouth (incidence similar in narcolepsy and OSA).

Conclusions: Solriamfetol showed consistent efficacy and safety in narcolepsy and OSA, with increased wakefulness, reduced sleepiness, and similar AE profiles for both groups.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.