Jazz Pharmaceuticals plc announced positive efficacy results from the global multicenter study of JZP-110 in adult patients with excessive sleepiness associated with narcolepsy. Based on the preliminary safety analysis, the most commonly reported adverse events in this study were generally consistent with those previously observed in the Phase 2 clinical studies evaluating JZP-110 in narcolepsy.

“Excessive sleepiness in narcolepsy remains an important unmet medical need, and we believe that the statistically and clinically significant effect observed in this study indicates that JZP-110 could be an important treatment option for patients,” says Karen Smith, MD, PhD, global head of research and development and chief medical officer of Jazz Pharmaceuticals, in a release. “Subject to completion of the data analysis and our regulatory discussions with FDA, we expect to submit the JZP-110 NDA for excessive sleepiness in obstructive sleep apnea and narcolepsy in late 2017. We are grateful to the patients and investigators who contributed to this successful study. This study exemplifies our ongoing and increasing commitment to R&D, as demonstrated by the large number of important clinical and regulatory activities that we have underway to bring new therapies to patients.”

Michael Thorpy, MD, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, Bronx, NY, says, “Patients with narcolepsy struggle with excessive sleepiness, which is the symptom of narcolepsy that patients report as having the most significant impact on their daily lives. Excessive sleepiness occurs in all patients with narcolepsy and when combined with frequent irresistible sleep attacks, can lead to a considerable burden of illness and adverse effect on patients’ health.”

The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program is comprised of four studies, two in obstructive sleep apnea (OSA) (TONES 3 and TONES 4 studies), one in narcolepsy (TONES 2 study) and one open-label, long-term safety and maintenance of efficacy study. The TONES 2 study enrolled 240 patients. The company plans to present the results from the TONES 2, TONES 3, and TONES 4 studies assessing the effect of JZP-110 on excessive sleepiness in narcolepsy and OSA at the APSS meeting in June.