Cara Therapeutics, Inc. reports statistically significant topline results from its Phase 2 trial of its lead kappa opioid agonist, CR845, for the treatment of moderate to severe uremic pruritus (UP). Uremic pruritus is a chronic systemic itch condition in patients with renal failure, often receiving hemodialysis. There are currently no approved products in the United States for the condition.

“These results demonstrate the potential of our lead candidate CR845 to address an additional indication of significant unmet need beyond our lead I.V. CR845 program in acute pain,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “With this encouraging data, we plan to engage the FDA in a formal meeting to guide the structure of a potential Phase 3 pivotal trial, which we would expect to begin in 2016.”