The FDA has lifted a clinical hold on a Phase 3 study involving Cara Therapeutics’ postoperative pain candidate.
The agency placed the hold on the study evaluating IV CR845 because elevated serum sodium levels were observed in some patients. The hold was based on a protocol-specified stopping rule for the adaptive trial during the first phase.
The company subsequently conducted an additional safety review and was cleared to resume the study. The study will continue as a three-arm trial testing two doses versus placebo.