Cara Therapeutics, Inc. announced the initiation of a first-in-man Phase 1 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 2 development for the treatment of acute postoperative pain with data expected in 1Q 2012. 

“Initiation of this Phase 1 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.”

Date: November 22, 2011
Source: Cara Therapeutics, Inc.