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.
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.
Concentric analgesics receives FDA Fast Track Designation for CA-008 for post-surgical pain [press release]. Los Altos, California: Concentric Analgesics; December 7, 2017. Accessed December 12, 2017.
This article originally appeared on MPR