The FDA has removed a clinical hold from a Phase 3 trial of Cara Therapeutic’s I.V. CR845 for postoperative pain.

“The Cara development team has worked diligently with the FDA to analyze patient data and conclude the Agency’s review process in a timely manner,” said Derek Chalmers, Ph.D., D.Sc., president and Chief Executive Officer of Cara.

The clinical had been triggered by a protocol-specified stopping criterion, based on elevated serum sodium levels, that was met during the first phase of the study.