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Cara Therapeutics Initiates Phase 3 Program for I.V. CR845 in Acute Postoperative Pain

First Pivotal Trial Will Evaluate I.V. CR845, Dosed Pre- and Postoperatively, in Patients Undergoing Abdominal Surgery

Top-line data expected in 1H'2016

SHELTON, Conn., Sept. 9, 2015 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced the initiation of its Phase 3 program for the intravenous (I.V.) formulation of CR845 in postoperative pain with the dosing of the first subjects in an adaptive pivotal trial in patients undergoing a range of abdominal surgeries.

"The initiation of this pivotal trial is an important step toward defining the clinical utility of I.V. CR845 for the treatment of acute postoperative pain," said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. "Following our successful Phase 2 trials with I.V. CR845 in patients undergoing laparoscopic hysterectomy and bunionectomy, we believe that positive results from this general abdominal surgery trial would continue to build a strong foundation for our overall Phase 3 program and ultimate planned submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration."

The CLIN3001 trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design trial with repeated doses of I.V. CR845 or placebo administered both prior to and following abdominal surgery in male and female patients. The trial...