DUBLIN, June 3, 2018 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that its investigational treatment solriamfetol demonstrated long-term maintenance of efficacy and a tolerable safety profile in the open-label Phase 3 TONES 5 study of excessive sleepiness (ES) in patients with narcolepsy or obstructive sleep apnea (OSA). Data from the study were presented in a poster today at the 32nd Annual Meeting of the Associated Professional Sleep Societies and will be featured in an oral presentation at the meeting on June 5 at 1:30 p.m. ET.
“As a leader in sleep medicine, Jazz is focused on addressing the needs of the sleep community through the research and development of new treatment options, and we are pleased that the results of this long-term study are consistent with the safety and efficacy that we have seen across the breadth of our clinical program for solriamfetol,” said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford Center for Sleep Sciences and Medicine. “If approved by the U.S. Food and Drug Administration, solriamfetol would offer patients the first new chemical entity for the treatment of excessive sleepiness in narcolepsy and OSA in the U.S. in nearly 10 years.”
In the TONES 5 study, patients with ES due to narcolepsy or OSA, including those who had completed prior studies with solriamfetol, began treatment with solriamfetol in the two-week titration phase followed by a maintenance phase of up to 50 weeks. A subset of patients participated in a two-week placebo-controlled Randomized Withdrawal (RW) phase after approximately six months of treatment. The primary endpoint in the RW phase was change in Epworth Sleepiness Scale (ESS) from beginning to end of the RW. Secondary endpoints were Patient and Clinician Global Impression of Change (PGI-C and CGI-C, respectively).
In this trial,