Cara Therapeutics initiates phase II CR845 trial
Cara Therapeutics has begun the dosing of the first patient in a phase II clinical trial of its peripherally-selective, kappa opioid agonist, CR845, for the treatment of acute post-operative pain. The double-blind, placebo-controlled trial is expected to enroll a minimum of 200 patients at multiple clinical sites in the United States, and will evaluate the efficacy and safety of intravenous CR845 administered both pre- and post-operatively in women undergoing laparoscopic hysterectomy. This trial follows the successful completion of a 46 patient, multi-center, double-blind phase II study of CR845, in the same surgical population, where both analgesic and opioid-sparing effects of CR845 were demonstrated and the drug was found to be safe and well tolerated after a single post-operative dose.
"This trial is of particular importance as it will reinforce previous positive phase II results for CR845 in a single-dose postoperative pain study," said Timothy Melson, M.D., study principal investigator, anesthesiologist and pain management specialist, at Helen Keller Memorial Hospital in Sheffield, AL.