Posted by Michael Wonder on 23 Jun 2017
Cara receives breakthrough therapy designation from FDA for I.V. CR845 for the treatment of chronic kidney disease associated pruritus in hemodialysis patients
23 June 2017 - Phase 3 safety extension trial underway.
Cara Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation to I.V. CR845 for the treatment of moderate-to-severe uremic pruritus in chronic kidney disease patients undergoing haemodialysis.
This regulatory decision was supported primarily by positive top-line results from Part A of a Phase 2/3 clinical trial of I.V. CR845 in patients with UP. Part A of the trial met its primary endpoint, with a 68% reduction in worst itching scores versus placebo after an eight-week treatment period (p < 0.0019), and its secondary endpoint, with a 100% improvement in quality of life domains versus placebo (p < 0.0007). I.V. CR845 was well-tolerated in the trial.
