Concentric Analgesics, a clinical-stage biopharmaceutical pain company, has initiated a phase Ib clinical trial with CA-008, a proprietary, water-soluble prodrug that converts into capsaicin, a potent TRPV-1 agonist. Results from this clinical trial are expected in the first quarter of 2018.

The phase Ib study is a randomized, double-blind clinical trial, targeting approximately 32 patients undergoing bunionectomy. The goal of the single, ascending-dose trial is to examine the safety, tolerability and pharmacokinetics of CA-008.

“This study marks an important milestone for Concentric, as we look forward to generating clinical data with CA-008 in surgical patients,” said John Donovan, M.D., CEO of Concentric Analgesics. “As an anesthesiologist, I can attest that there is a clear clinical mandate to reduce the reliance on opioids after surgery, especially in the 24 to 96 hour time window when the intensivity of care shifts from provider to patient. CA-008’s therapeutic profile as a long-acting, site-specific non-opioid analgesic makes it uniquely positioned to address this critical unmet medical need. Our mission of displacing opioids in multi-modal post-surgical pain management has never been more important.”

“CA-008 has the potential to dramatically improve how we manage post-surgical pain, particularly in the initial 24 to 96 hours, thereby reducing the need for opioids,” said Michael F. Dillingham, M.D., Adjunct Clinical Professor, Department of Orthopaedic Surgery at Stanford University, and Program Director, SOAR (Sports Orthopedic and Rehabilitation) Medical Associates in Palo Alto, CA. “The drug’s potential to deliver a long-lasting, pain-selective effect following a simple, single administration is very attractive and could help establish CA-008 as an important new standard of care.”

The national spotlight on the opioid epidemic continues to grow. 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.

Recent figures from the Centers for Disease Control and Prevention suggest that 145 Americans now die every day from opioid overdoses, while a 2013 study in Pharmacotherapy documents the widespread toll of opioid-related adverse events on patients, the health care system and society at large, including:

• 4x higher risk of inpatient mortality
• 55% longer length of stay (hospitalization)
• 47% higher cost of care
• 36% increased risk of 30-day readmission

In addition to the company’s post-surgical program, Concentric expects to complete a series of pre-clinical research studies by the end of 2017 for CA-011, its program in osteoarthritis. Osteoarthritis is the most common joint disease affecting over 30 million Americans, more than 14 million of whom suffer from osteoarthritis of the knee.