USA – FDA awards another non-opioid pain drug breakthrough status

Second drug fast-tracked amid addiction epidemic. The FDA is prioritising the approval of new non-opioid pain treatments, as part of the US battle against its opioid addiction epidemic.

The US regulator yesterday awarded Concentric Analgesics and its pipeline drug CA-008 in post-surgical pain with an FDA Breakthrough Therapy designation (BTD).

Concentric specialises in novel non-opioid pain therapeutics, and CA-008 is a first-in-class non-opioid therapeutic that rapidly converts to capsaicin, a potent TRPV1-agonist.

The company says CA-008 provides long-lasting pain relief after a single, local injection by selectively desensitising pain-conducting nerve fibres, without producing numbness or weakness.

Frank Bellizzi, CEO of Concentric Analgesics said the BTD confirmed the strong early data for the treatment, which is designed to treat pain and eliminate the need for opioids in the post-operative period.

The Breakthrough Therapy designation is based on phase Ib placebo-controlled clinical trial in patients undergoing bunionectomy. In this study, CA-008, at the highest dose, showed a 63% reduction of pain intensity when compared to placebo, and a nearly 50% reduction in opioid consumption in patients taking CA-008, compared to placebo…