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Cara Therapeutics Initiates Phase I Study with Oral Formulation of Novel Peripherally-Acting Kappa Opioid Agonist
Date:11/22/2011

SHELTON, Conn., Nov. 22, 2011 /PRNewswire/ -- Cara Therapeutics, Inc. today announced the initiation of a first-in-man Phase I clinical trial of an oral formulation of its peptide-based, kappa opioid agonist, CR845, in healthy volunteers. The double-blind, placebo-controlled trial is expected to enroll up to 60 subjects at a single U.S. site and will evaluate the pharmacokinetic, pharmacodynamic and safety profile of single escalating doses of CR845 in enteric-coated capsules. An intravenous formulation of CR845 is currently in Phase II development for the treatment of acute postoperative pain with data expected in 1Q'12. 

"Initiation of this Phase I trial represents an important advancement in the clinical potential of CR845 and will provide the basis for developing the drug beyond the treatment of acute pain in a hospital setting," said Frederique Menzaghi, V.P. of R&D at Cara Therapeutics. "There remains a significant unmet need among chronic pain patients for an effective analgesic without the debilitating or dangerous side-effects of currently used narcotic analgesics and NSAIDs. We believe that an oral formulation of CR845 has the potential to provide an effective and safer option for the treatment of chronic pain."

About CR845

CR845 is a highly selective, peptide-based, peripherally-restricted kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain.  In a previous randomized, placebo-controlled Phase II study, CR845 demonstrated evidence of analgesic efficacy when administered as a single intravenous dose to women following laparoscopic hysterectomy.  In addition to decreases in reported pain levels, patients receiving CR845 required substantially lower amounts of post-operative opioids (narcotics) and showed a significant reduction in the incidence of post-operative nausea and vomiting. A multicenter double-blind, randomized, placebo-controlled 200-patient Phas
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SOURCE Cara Therapeutics, Inc.
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