Cara Therapeutics Inc. (NASDAQ: CARA) saw its shares jump early on Wednesday after the U.S. Food and Drug Administration (FDA) made a favorable judgment for them. The company announced that it has received notice from the FDA concerning removal of the clinical hold on its adaptive Phase 3 trial of I.V. CR845 for postoperative pain.
Previously, this clinical hold was the result of a protocol-specified stopping criterion, based on elevated serum sodium levels, which was met during the first phase of the study.
After the fact, a review of the unblinded safety data from the first 90 patients 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 in fact 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. But the important fact is that this study will continue.
Derek Chalmers, Ph.D., D.Sc., president and CEO of Cara, commented:
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. 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.
So far in 2016, Cara has suffered, with the stock down over 50%, and looking at the past 52 weeks, the stock is down over 30%.
Shares of Cara were up 8.2% at $8.89 shortly after Wednesday opening bell, with a consensus analyst price target of $24.00 and a 52-week trading range of $4.26 to $23.61.
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