FDA grants breakthrough therapy designation for Concentric Analgesics’ CA-008 in post-surgical pain

Concentric Analgesics

11 September 2018 - Concentric Analgesics announced today that it has received breakthrough therapy designation from the U.S. FDA) for CA-008 in post-surgical pain. 

CA-008 is a first-in-class non-opioid therapeutic that rapidly converts to capsaicin, a potent TRPV1-agonist. CA-008 provides long-lasting pain relief after a single, local injection by selectively desensitising pain-conducting nerve fibres, without producing numbness or weakness.

The breakthrough therapy designation for CA-008 is supported by data from the Company’s Phase 1b placebo-controlled clinical trial in patients undergoing bunionectomy. In this study, CA-008, at the highest dose, showed a statistically significant and clinically meaningful 63% reduction of pain intensity for area under the curve (AUC 0-168h) when compared to placebo. The study also showed statistically significant milestone reductions of pain with CA-008 at each of the time-points of 48h, 72h, 96h and 120h. Importantly, there was a nearly 50% reduction in opioid consumption in patients taking CA-008, compared to placebo. CA-008 was safe and well tolerated at all doses in this clinical study.

Read Concentric Pharmaceuticals press release

Michael Wonder

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Michael Wonder