Novel Prodrug with Unique Mechanism of Action Takes on the Opioid
LOS ALTOS, Calif.–(BUSINESS WIRE)–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
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
“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.