ir.caratherapeutics.com
Apr 20, 2016
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Cara Therapeutics Announces Removal of FDA Clinical Hold on CLIN3001 Postoperative Pain Trial for I.V. CR845- Patient recruitment expected to resume in May
- Study to evaluate two doses of I.V. CR845 versus placebo
SHELTON, Conn., April 20, 2016 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that it has removed the clinical hold on its adaptive Phase 3 trial of I.V. CR845 for postoperative pain.
The clinical hold was triggered by a protocol-specified stopping criterion, based on elevated serum sodium levels, that was met during the first phase of the study. A subsequent review of unblinded safety data from the first 90 patients dosed was completed by Cara, the study's Independent Data Monitoring Committee (IDMC), and the FDA.
The results of this safety data review confirmed 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. Based on this safety review and an analysis of efficacy trends, the study will continue as a three-arm trial testing two doses of CR845 (1 ug/kg and 0.5 ug/kg) versus placebo.
"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." |
