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Cara begins oral opioid agonist first-in-man Phase I clinical trial

Cara Therapeutics has started first-in-man Phase I clinical trial of its oral, peptide-based, kappa opioid agonist - CR845 - to treat acute and chronic pain.

The double-blind, placebo-controlled trial, enrolling 60 US subjects, is designed to assess the pharmacokinetic, pharmacodynamic and safety profile of single escalating doses of CR845 in enteric-coated capsules.

Cara Therapeutics R&D VP Frederique Menzaghi said initiation of the 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.

"We believe that an oral formulation of CR845 has the potential to provide an effective and safer option for the treatment of chronic pain," Menzaghi said.

The company is currently in Phase II development of an intravenous formulation of CR845 to treat acute postoperative pain.