Jazz Pharmaceuticals announced positive efficacy results from two Phase 3 studies of JZP-110 for the treatment of adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA).
The first study, TONES 3, is a global, multicenter, randomized, 5-arm, parallel-group, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of four doses of JZP-110 (300mg, 150mg, 75mg, 37.5mg) vs. placebo in 476 OSA patients for a 12-week period. The co-primary endpoints are the change in mean sleep latency on the Maintenance of Wakefulness test (MWT) and the change in the Epworth Sleepiness scale (ESS) score, from baseline to week 12. The secondary endpoint is the change on the PGIc scale, a patient-reported measure of improvement, worsening, or no change in overall condition from baseline to week 12.
Results from TONES 3 showed that all four doses of JZP-110 (300mg, 150mg, 75mg, 37.5mg) demonstrated highly statistically significant improvement in the co-primary endpoints of MWT and ESS. Compared to placebo, treatment with JZP-110 significantly increased the patients’ ability to stay awake and significantly decreased patients’ subjective levels of sleepiness, respectively, throughout the course of the study. Additionally, all doses also demonstrated a highly statistically significant improvement in the secondary endpoint of PGIc scale.
The second study, TONES 4, is a global, multicenter, six-week Phase 3 study comprising a two-week flexible-dose titration phase followed by two weeks at stable dose, and then a two-week, placebo-controlled, double-blind randomized withdrawal phase. Primary analyses of the trial evaluated the difference on the co-primary endpoints of MWT and ESS between JZP-110 and placebo from the end of the stable dose phase at Week 4 to the end of the randomized withdrawal phase at Week 6.
In the TONES 4 study, treatment with JZP-110 demonstrated highly statistically significant differences in the MWT and ESS endpoints in the combined JZP-110 treatment arm (300mg, 150mg, and 75mg doses) vs. placebo. Patients randomized to continue on JZP-110 maintained efficacy, while those randomized to placebo experienced a loss of efficacy, as measured by the co-primary and key secondary endpoints.
Preliminary safety analysis of both studies found that headache, nausea, decreased appetite, dry mouth, anxiety, dizziness, insomnia, nasopharyngitis, and palpitations were the most commonly reported adverse events (AEs). Additional safety data will be available based on the final analyses of the JZP-110 program.
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI).
For more information visit Jazzpharma.com.