FDA Grants Breakthrough Therapy Designation for CA-008

Concentric Analgesics has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for CA-008 in post-surgical pain. CA-008 is a first-in-class non-opioid therapeutic that rapidly converts to capsaicin, a potent TRPV1-agonist. CA-008 provides long-lasting pain relief after a single, local injection by selectively desensitizing pain-conducting nerve fibers, without producing numbness or weakness.

Breakthrough Therapy designation is designed to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and for which preliminary clinical evidence indicates substantial improvement over existing therapies on one or more clinically significant endpoints. In December 2017, CA-008 also received Fast-Track designation from the FDA.

"Receiving Breakthrough Therapy designation for CA-008 is significant at this early stage of clinical development, and firmly supports the compelling data we have seen to date in post-surgical pain," said Frank Bellizzi, Chief Executive Officer of Concentric Analgesics. "CA-008 is designed to provide clinically meaningful and long-lasting pain relief, significantly reducing or eliminating the need for opioids in the post-operative period. We look forward to working closely with the FDA to develop an expedited pathway to bring CA-008 to clinicians and patients as quickly as possible."

The Breakthrough Therapy designation for CA-008 is supported by data from the company’s Phase 1b placebo-controlled clinical trial in patients undergoing bunionectomy. In this study, CA-008, at the highest dose, showed a statistically significant and clinically meaningful 63% reduction of pain intensity for area under the curve (AUC 0-168h) when compared to placebo. The study also showed statistically significant milestone reductions of pain with CA-008 at each of the timepoints of 48h, 72h, 96h and 120h. Importantly, there was a nearly 50% reduction in opioid consumption in patients taking CA-008, compared to placebo. CA-008 was safe and well tolerated at all doses in this clinical study.

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