Concentric Analgesics Receives FDA Fast Track Designation for CA-008 for Post-Surgical Pain

Concentric Analgesics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CA-008 for the treatment of post-surgical pain. CA-008 is a proprietary water-soluble prodrug that converts into capsaicin, a potent TRPV-1 agonist.

Fast Track is a designation by the FDA designed to facilitate the development and expedite the review of drugs which treat serious or life-threatening conditions and fill an unmet medical need. Its purpose is to get important new therapeutics to the patient earlier. Recipients receive an enhanced level of interaction and support from the FDA and there is a strong historical correlation between Fast Track designation and receiving priority review after filing an NDA.

“Concentric Analgesics is pleased to have received Fast Track designation for CA-008, less than two weeks after submission,” said John Donovan, MD, CEO of Concentric. “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.”

CA-008 is currently being tested in a randomized, double-blind Phase 1b clinical trial, in patients undergoing bunionectomy. The goal of this single, ascending-dose trial is to examine the safety, tolerability and pharmacokinetics of CA-008. Results are expected in the first quarter of 2018.

“The unusually rapid granting of Fast Track for Concentric Analgesics’ post-surgical therapeutic, CA-008, demonstrates the FDA’s commitment to aggressively address the opioid crisis and work with innovative companies such as Concentric to help bring forward novel therapeutics that effectively treat pain without the risk of addiction,” said Richard Lowenthal, President of Pacific-Link Regulatory Consulting.