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29th April 2013
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22nd April 2013
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11th June 2012Cara Therapeutics Reports Positive Results from Phase II Trial of Novel Peripheral Kappa Agonist, CR845, in Acute Post-Operative Pain
Cara Therapeutics, Inc. today announced positive results from a Phase II study for the treatment of acute post-operative pain with its novel, peptide-based, peripherally-acting kappa opioid agonist, CR845. The study successfully met its primary endpoint which measured the effect of CR845 treatment on reducing the amount of rescue opioid analgesics used in the 24 hour period post-surgery, as well as secondary endpoints which evaluated the ability of CR845 to reduce post-operative pain as assessed by a number of standard measures, including pain intensity differences (PIDs), summed pain intensity differences (SPIDs), and patient evaluation of study medication over the post-surgical 24-hour period.
The Phase II study was a double-randomized, double-blind, placebo-controlled study of intravenous CR845 (0.04mg/kg/dose) in women undergoing a laparoscopic hysterectomy. The trial was conducted at 22 sites across the U.S., and enrolled 203 patients who were randomized into four treatment arms: (1) both a pre-and a post-operative dose of CR845; (2) a single pre-operative dose of CR845; (3) a single post-operative dose of CR845; and (4) both pre- and post-operative placebo. Patients receiving both a pre- and post-operative dose of CR845 achieved the study’s primary endpoint by exhibiting a statistically significant reduction (~33%, p<0.05) of morphine use over 24 hours compared to the placebo group. This patient group also exhibited an approximately two-fold (~100%) increase in their calculated 24 hour PID0-24 (p=0.002) and SPID0-24 (p=0.003) values compared to placebo-treated subjects. Significant 24-hour analgesic effects were also seen in patients receiving a single post-operative dose of CR845 where SPID0-24 values (p=0.014) increased by more than 50%when compared to placebo. Global evaluation of study medication by all patients indicated a significant treatment effect of CR845 (p=0.006), with 80% of subjects receiving a pre- and post-operative dose of CR845 rating the drug as good-to-excellent. Pre- and/or post-surgical dosing of CR845 was safe and well tolerated, and was generally associated with a decreased incidence of the common opioid-related side effects of nausea, vomiting and pruritus. Importantly, CR845 did not produce any of the CNS-related effects seen with centrally-acting kappa opioid agonists.
“The results of this Phase II trial have further confirmed the robust analgesic efficacy of CR845 in this acute post-operative setting,” said James B. Jones, M.D., Pharm. D., Chief Medical Officer of Cara Therapeutics. “Moreover, these data have established the clear clinical advantage of dosing CR845 before and after surgery in significantly reducing the severity of patient pain and the need for opioid rescue medication in the first 24 hours post-surgery.”
Dr. Tong J. Gan, study Principal Investigator, Professor of Anesthesiology & Vice Chair for Clinical Research at Duke University commented: “Postoperative pain is still poorly managed and there is a need for novel anti inflammatory and analgesic drugs for perioperative pain management. These results indicate that this new class of anti-inflammatory/analgesic can potentially be used in a multimodal analgesic strategy, including preoperative dosing, to improve postoperative pain and reduce the need for morphine and other opioids.”
“This trial with CR845 has clearly demonstrated that a peripherally-selective kappa opioid agonist is a fundamentally new and viable option for the treatment of acute post-op pain,” said Derek Chalmers, Ph.D., President and CEO at Cara. “We have now treated over 300 patients with CR845 and have not seen any of the psychiatric side effects that have precluded the development of centrally-acting kappa opioid agonists. Additionally, we now have strong evidence of the clinical benefit of pre-operative dosing of CR845 which is a key differentiating aspect of our product as NSAIDs are no longer used in this setting due to the increased risk of bleeding.”
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