Jazz Pharmaceuticals Presents Long-Term Safety and Efficacy Data from Phase 3 TONES 5 Study of Solriamfetol for Excessive Sleepiness in Narcolepsy or Obstructive Sleep Apnea
Summary
"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.For both secondary endpoints (PGI-C and CGI-C), significantly greater percentages of patients who were switched to placebo were rated by their physicians and themselves as worse in their overall condition at the end of the RW compared with the solriamfetol group (both P <0.0001).In these areas, Jazz Pharmaceuticals markets Xyrem ® (sodium oxybate) oral solution, Erwinaze ® (asparaginase Erwinia chrysanthemi ), Defitelio ® (defibrotide sodium) and Vyxeos ® (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Erwinase ® and Defitelio ® (defibrotide) in countries outside the U.S. For country-specific product information, please visit www.jazzpharmaceuticals.com/products .These forward-looking statements are based on the companys current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.Related Links 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).