Cara Therapeutics has resumed patient recruitment after the FDA removed a clinical hold on its CLIN3001 adaptive Phase 3 trial of I.V. CR845 for postoperative pain.
“This pivotal study will continue as a three-arm trial comparing two doses of CR845 to placebo,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics.
CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus.
In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in both pain intensity and opioid-related side effects.