Jazz Xyrem fibromyalgia Phase III program
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Jazz Pharmaceuticals has initiated a Phase III trial of Xyrem (sodium oxybate) for treatment of fibromyalgia syndrome, the company announces Sept. 7. The randomized, double-blind, placebo-controlled trial will enroll both males and females 18 years and older who meet the American College of Rheumatology diagnostic criteria for fibromyalgia. Other drugs in development for fibromyalgia include Lilly's serotonin-norepinephrine reuptake inhibitor Cymbalta (duloxetine); Wyeth's Effexor follow-on desvenlafaxine (DVS-233) and Forest's SNRI milnacipran...