The Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational treatment CA-008 (Concentric Analgesics) for the treatment of post-surgical pain

CA-008 is a water-soluble prodrug that converts into capsaicin, a naturally occurring molecule that is a potent TRPV-1 agonist. An ongoing Phase 1b randomized, double-blind trial is currently testing CA-008 in patients undergoing bunionectomy. The safety, pharmacokinetics, and tolerability findings from this single, ascending dose study are expected in the first quarter of 2018.  

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Capsaicin selectively and reversibly desensitizes pain conducting nerve fibers (C-fiber nociceptors). Agonists of TRPV-1 induce a durable refractory state to provide sustained analgesia. “We take seriously the responsibility of this important designation and look forward to working closely with the FDA to bring CA-008 to clinicians and patients as expeditiously as possible,” said John Donovan, MD, CEO of Concentric. 

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