INCIDENCE AND DURATION OF COMMON ADVERSE EVENTS IN A SOLRIAMFETOL (JZP-110) PHASE 3 STUDY FOR TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN OBSTRUCTIVE SLEEP APNEA

Solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor, reduced excessive daytime sleepiness (EDS) and increased wakefulness in participants with obstructive sleep apnea (OSA) in a phase 3 study. Post-hoc analysis evaluated timing and duration of common, early-onset, treatment-emergent adverse events (TEAEs). Patients (N=474) with OSA and EDS were randomized to 12 weeks placebo or solriamfetol 37.5, 75, 150, or 300 mg. Common, early-onset TEAEs were defined as those occurring in ≥5% of participants in any solriamfetol dose group and greater than placebo during week 1. For TEAEs identified during week 1, incidence of new occurrence or change in severity over time was calculated for each subsequent study week. Analysis included placebo (n=119) and combined solriamfetol groups (n=355). Common early-onset TEAEs during week 1 across all solriamfetol doses were decreased appetite (5.6%), headache (5.1%), anxiety (3.9%), nausea (3.7%), feeling jittery (3.7%), and insomnia (3.1%). Incidence was highest at week 1 and decreased over time; at week 12, only headache, nausea, and anxiety TEAEs were reported (all 0.3%). Fourteen of 25 TEAE-related discontinuations on solriamfetol were due to a common early-onset TEAE (1, decreased appetite [0.3%]; 1, headache [0.3%]; 4, anxiety [1.1%]; 3, nausea [0.8%]; 4, feeling jittery [1.1%]; 1, insomnia [0.3%]). Median durations (days; [min, max]) for common TEAEs were decreased appetite, 57 (5, 91); headache, 5.5 (1, 112); anxiety, 26 (1, 94); nausea, 10 (1, 86); feeling jittery, 4 (1, 49); insomnia, 8.5 (1, 49). In a phase 3 clinical trial of solriamfetol for the treatment of EDS in participants with OSA, common early-onset TEAEs were decreased appetite, headache, anxiety, nausea, feeling jittery, and insomnia. Most early-onset TEAEs had a median duration ≤10 days; and while all diminished over time, they accounted for ~50% of TEAE-related discontinuations across the study. This analysis may inform clinician and patient expectations regarding type, course, and duration of common early-onset TEAEs associated with solriamfetol therapy. Jazz Pharmaceuticals.