0642 A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF JZP-110 IN THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA: SF-36 AND EQ-5D-5L MEASURES

Excessive sleepiness (ES) is a frequent symptom of obstructive sleep apnea (OSA) and persists in some patients despite primary OSA therapy and can adversely impact health-related quality-of-life (HRQoL). JZP-110 is a selective dopamine norepinephrine reuptake inhibitor with wake-promoting effects. The efficacy and safety of JZP-110 for the treatment of ES in OSA were evaluated in a phase 3 study for patients with OSA. This also included measures of health-related quality-of-life (HRQoL) as pre-specified secondary endpoints. Eligibility criteria in this study included: OSA diagnosis according to International Classification of Sleep Disorders-3 criteria; past or present use of a primary OSA therapy; Epworth Sleepiness Scale score ≥10; mean sleep latency <30 minutes on the first 4 trials of a 5-trial, 40-minute Maintenance of Wakefulness Test; and usual nightly sleep time ≥6 hours. Patients were randomized (1:1:2:2:2) to JZP-110 37.5mg, 75mg, 150mg, or 300mg, or placebo for 12 weeks, stratified by adherent or non-adherent use of a primary OSA therapy. HRQoL was assessed as changes from baseline to week 12 using the 36-Item Short Form Health Survey version 2 (SF-36v2) and the 5-dimension, 5-level EuroQoL questionnaire (EQ-5D-5L). Safety and tolerability were also evaluated. Complete enrollment of this trial occurred in September 2016. Preliminary data from 427 (of the 476 randomized) patients were 62.1% male, 74.9% white, and a mean±SD age of 54.2 ± 10.6 years. At baseline, the Clinical Global Impression of Severity showed that 41.5%, 33.3%, 12.2%, and 2.8% of patients were moderately, markedly, severely, and extremely ill, respectively. All patients have completed participation in the study and data are being analyzed; complete HRQoL and safety results will be available and reported. Complete data on the effects of JZP-110 on the SF-36v2 and EQ-5D-5L HRQoL measures and safety information will be reported at the time of presentation. Jazz Pharmaceuticals