Cara Therapeutics (CARA) Commences CR845 Phase 2b Enrollment

September 15, 2016 7:02 AM EDT

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Cara Therapeutics, Inc. (Nasdaq: CARA) announced the initiation of patient enrollment in a Phase 2b trial of an oral tablet formulation of its peripherally selective kappa opioid agonist, CR845, for the treatment of pain associated with osteoarthritis (OA). The Company expects to report top-line data from this trial during the first half of 2017.

“The initiation of this osteoarthritis trial is an important step in establishing the potential clinical utility of CR845 in the treatment of chronic inflammatory pain,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “The biggest challenge in analgesic development today centers on providing effective medications that lack the abuse burden of traditional pain drugs, and it appears from our previous preclinical and human abuse liability data that CR845 could represent a novel, non-addicting approach to the treatment of chronic pain.”

The Phase 2b trial is a randomized, double-blind, placebo-controlled trial of three tablet strengths of CR845, 1.0 mg, 2.5 mg and 5.0 mg, dosed twice a day (BID) over an eight-week treatment period in approximately 330 osteoarthritis patients experiencing moderate-to-severe pain. The primary efficacy endpoint will be change from baseline at week eight, with respect to the weekly mean of the daily pain intensity score using a numerical rating scale (NRS). Secondary endpoints will include: change from baseline in the Western Ontario and McMaster Osteoarthritis Index (WOMAC), the Patient Global Impression of Change (PGIC) and amount of rescue medication used.

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