Dec 7, 2017
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.
Nov 2, 2017
Concentric Analgesics, Inc., a clinical-stage
biopharmaceutical pain company, announced today that it has initiated a Phase 1b 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 1b 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.
Oct. 17, 2017
Concentric Analgesics, Inc., a development-stage biopharmaceutical pain company, announced today that it has appointed Thomas B. King to its Board of Directors. Mr. King brings nearly 40 years of leadership experience building, operating and selling multiple biopharmaceutical businesses.
“Tom brings significant strategic development, regulatory and commercialization experience to the Concentric Analgesics board, which will be valuable as we advance our lead program, CA-008, in post-surgical pain to the clinic, and look to commence IND-enabling studies for CA-011, our osteoarthritis pain program,” said John Donovan, M.D., Chief Executive Officer of Concentric Analgesics. “We are thrilled to have Tom join the Concentric team, particularly at such a transformative time for the company.”