Cara Therapeutics Gains 9% After The FDA Removed A Clinical Hold On An Ongoing Trial

Shares of Cara Therapeutics Inc CARA were trading higher by more than 9 percent early Wednesday morning after the company confirmed the U.S. Food and Drug Administration (FDA) removed a hold on a clinical trial. Cara Therapeutics said that it received notice from the FDA that the agency removed a clinical hold on its adaptive Phase 3 trial of I.V. CR845 for postoperative pain. The clinical hold was the triggered by a protocal-specific stopping criterion that was based on elevated serum sodium levels. A subsequent review of safety data from the first 90 patients dossed was completed by the company, along with an Independent Data Monitoring Committee and the FDA itself. The safety data review showed that increases in serum sodium levels in CR845-treated patients beyond the normal range were dose-dependent and asymptomatic with the lowest frequency of events found in the 1 ug/kg I.V. CR845 group. "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 Therapeutics. "Our unblinded analysis of the initial cohort of patients has identified interim efficacy signals for pain, supplemental opioid use and opioid-related side effects that support our dose selections. We look forward to continuing patient recruitment next month and to providing further updates on our progress later this year."