From BusinessWire Concentric Analgesics, Inc., a clinical-stage biopharmaceutical pain company, announced today 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.
ABOUT THE OPIOID CRISIS
Opioid addiction in the United States has reached epidemic proportions, destroying families, lives and communities throughout the country. According to preliminary estimates from the Centers for Disease Control and Prevention, opioid overdoses were responsible for 53,000 US deaths in 2016, topping the death toll from guns, car crashes, and HIV/AIDS at the peak of the epidemic.
New approaches to 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 US 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.
ABOUT CA-008 & CA-011
Concentric Analgesic’s lead investigational product candidates, CA-008 & CA-011, are proprietary water-soluble prodrugs that convert into capsaicin – the naturally occurring molecule that gives chili peppers their heat and is a potent TRPV-1 agonist. Capsaicin, which has a long history of use as a topical analgesic, selectively and reversibly desensitizes pain conducting nerve fibers (C-fiber nociceptors). TRPV-1 agonism evokes an initial neuronal excitation that is followed by a durable refractory state to provide long lasting analgesia.
ABOUT CONCENTRIC ANALGESICS
Concentric Analgesics, Inc. is a privately-held, clinical-stage biopharmaceutical company focused on discovering and developing novel, non-opioid therapeutics for the management of acute and chronic pain. Concentric’s lead program for post-surgical pain, CA-008, is currently being evaluated in a Phase 1b clinical trial. The Company’s osteoarthritis pain program, CA-011, is expected to complete IND-enabling studies in 2018. For more information, please visit www.concentricanalgesics.com.