Cara Therapeutics reports the successful completion of its End-of-Phase 2 Meeting with the FDA. Cara, in consultation with the FDA, has established the key elements of the Phase 3 program to support a New Drug Application for I.V. CR845 for the treatment of moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients.
Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics, said, “We expect to initiate our pivotal Phase 3 program of I.V. CR845 for the treatment of CKD-aP in hemodialysis patients in the U.S. by the end of 2017, and will continue working closely with the agency to develop CR845 as a potential new therapeutic option for this highly debilitating aspect of CKD as quickly as possible.”