Cara Therapeutics Inc (NASDAQ: CARA), a clinical-stage bio-pharmaceutical company that focuses on the development of chemical entities to alleviate pain and pruritus, announced a business update after Thursday's market close.
Cara Therapeutics said that the U.S. Food and Drug Administration has placed the company's adaptive pivotal trial of I.V. CR845 on protocol clinical hold pending a pre-specific safety review. The company did, however, note that no serious adverse events associated with its CR845 have been reported.
Cara Therapeutics added that a review of safety data has been undertaken by both the company and its Independent Data Monitoring Committee in accordance with the protocol.
"We are working closely with the FDA to review patient safety data and resolve this issue in a timely manner," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We remain very confident in the overall efficacy and safety profile of I.V. CR845 in the treatment of postoperative pain, and are encouraged that there have been no serious CR845-related adverse events so far in our Phase 3 program. We look forward to continuing the study, pending FDA review, as we work to bring this novel class of therapeutics to patients in need of additional pain treatment options."
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