Concentric Analgesics announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to CA-008, a non-opioid therapy for post-surgical pain.
CA-008 is a first-in-class injectable prodrug of capsaicin, a potent TRPV1-agonist. CA-008 is given as a single local injection and works by selectively desensitizing pain-conducting nerve fibers without causing numbness or weakness; it is intended to provide meaningful pain relief for ≥1 week. The investigational agent previously received a Fast Track designation from the FDA in December 2017.
Findings from the Phase 1b placebo-controlled trial in patients undergoing bunionectomy showed a statistically significant and clinically meaningful reduction of pain intensity (63%) for AUC (0–168 hours) at the highest dose vs placebo. In addition, treatment with CA-008 demonstrated statistically significant reductions in pain at each of the timepoints: 48 hours, 72 hours, 96 hours, and 120 hours. Moreover, compared with placebo, patients administered CA-008 cut their opioid consumption by approximately 50%. The drug was found to be safe and well-tolerated at all doses in the study.
“Receiving Breakthrough Therapy designation for CA-008 is significant at this early stage of clinical development, and firmly supports the compelling data we have seen to date in post-surgical pain,” said Frank Bellizzi, Chief Executive Officer of Concentric Analgesics.
For more information visit Concentric Analgesics.com.