0763 Effects Of Solriamfetol On Driving Performance In Participants With Narcolepsy. (27th May 2020) - Vinckenbosch, F
Abstract: Introduction: Patients with narcolepsy have an increased risk of automobile accidents. Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved in the US (Sunosi ® ) for adults with excessive daytime sleepiness (EDS) associated with narcolepsy (75-150 mg/day). This study evaluated the effects of solriamfetol on on-road driving performance in participants with narcolepsy. Methods: In each period of this randomized, double-blind, placebo-controlled, crossover study (NCT 02806908; EudraCT 2015-003931-36), driving performance during an on-road driving test (a 1-hour drive on a public highway) was assessed at 2 hours and 6 hours postdose following 7 days of treatment with solriamfetol (150 mg/day × 3, then 300 mg/day × 4) or placebo. For assessment of driving performance, the primary endpoint was standard deviation of lateral position (SDLP), a measure of "weaving, " at 2 hours postdose. Comparisons (solriamfetol vs placebo) used a Wilcoxon signed-rank test. Results: The study included 24 participants (54% male; mean age, 40 years); 22 were included in the analyses of SDLP data. At 2 hours postdose, SDLP for solriamfetol (median, 19.08 cm) was statistically significantly lower than that for placebo (median, 20.46 cm; P =0.0022; incomplete driving tests: solriamfetol, n=4; placebo, n=7), indicating a better performance with solriamfetol. At 6 hours postdose, SDLP for solriamfetol (median, 19.59 cm) was not statistically significantly different from that for placebo (median, 19.78 cm; P =0.1245; incomplete driving tests: solriamfetol, n=3; placebo, n=10). Common adverse events (≥5%) were headache, decreased appetite, somnolence, sleep disorder, agitation, nausea, and palpitations. Conclusion: Solriamfetol (300 mg/day) improved SDLP, an important measure of driving performance, at 2 hours after administration in participants with narcolepsy. Support: Jazz Pharmaceuticals