0622 Solriamfetol (JZP-110) in the Treatment of Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Maintenance of Wakefulness Test Results Across the Day

Abstract

Objectives/Introduction: Phase 3 trials in adults with narcolepsy or obstructive sleep apnoea (OSA) demonstrated robust wake‐promoting effects of solriamfetol on a 40‐min Maintenance of Wakefulness Test (MWT). The subsequent analyses reported here were performed to evaluate the time course of solriamfetol on each MWT trial after morning dosing. Methods: Participants were randomised to receive placebo or solriamfetol 37.5 (OSA only), 75, 150, or 300mg. As pre‐specified, only doses efficacious for both coprimary endpoints (MWT overall sleep latency and Epworth Sleepiness Scale score at week 12) were further tested at each MWT trial (MWT1: 1‐hr post‐dose, MWT2‐5: 2‐ hr consecutive intervals post‐dose; total time: ≈ 9 hr post‐dose). The first trial with significant change (∗p < 0.05) was identified and testing to the next trial was performed until non‐significance or MWT5 was reached. Results: In general, efficacious doses of solriamfetol showed a significant change from baseline on each of the 5 individual MWT trials at week 12, with the exception of 37.5 mg for OSA and 75 mg for narcolepsy. In participants with narcolepsy, solriamfetol 150mg and 300mg demonstrated significant least squares (LS) mean change (standard error) from baseline to week 12 at each time trial from MWT1 (150mg 9.9∗ [1.7], 300mg 9.9∗ [1.8], placebo ‐0.6 [1.7]) to MWT5 (150mg 9.3∗ [1.9], 300mg 12.2∗ [2.0], placebo 3.1 [1.8]). In participants with OSA, solriamfetol 75mg, 150mg, and 300mg demonstrated significant LS mean change from baseline to week 12 at each time trial from MWT1 (75mg 5.8∗ [1.8], 150 mg 10.9∗ [1.3], 300mg 12.5∗ [1.4], placebo ‐0.4 [1.3]) to MWT5 (75 mg 7.8∗ [1.8], 150 mg 8.1∗ [1.3], 300 mg 7.6∗ [1.4], placebo 0.2 [1.4]). Common treatment‐emergent adverse events in both narcolepsy and OSA populations included headache, nausea, decreased appetite, anxiety, and nasopharyngitis, and were mild to moderate. Conclusions: Treatment with solriamfetol (75 mg in OSA, and 150 and 300 mg in OSA and narcolepsy) was associated with sustained improvements in wakefulness, from 1 hr to 9 hr after morning dosing. Safety and tolerability in both populations were consistent with previous studies of solriamfetol.