FDA Grants Breakthrough Therapy Designation for Concentric Analgesics’ CA-008 in Post-Surgical Pain

SAN FRANCISCO--(BUSINESS WIRE)--Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics, announced today that it 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.

About Opioid Addiction & Post-Surgical Pain

Opioid addiction in the United States has reached epidemic proportions, destroying families, lives and communities throughout the country. New approaches for preventing this insidious disease are imperative, including in the post-surgical setting, which can be an unsuspecting gateway to prescription pain medicine abuse and beyond. A 2016 US News & World Report revealed that one in 10 patients report becoming addicted or dependent on opioids following surgery. With more than 100 million surgeries being performed in the U.S. in 2017, 30 million of which require post-surgical pain management with non-over the counter (OTC) pain medications, the mandate to develop safe and effective non-opioid alternatives is clear.