Topical Agent for Diabetic Neuropathy on FDA Fast Track

A drug intended to treat diabetic neuropathic pain received fast track designation from the FDA.

The drug, ARC-4588, is developed by Arcion Therapeutics, a clinical stage biotechnology company that specializes in developing topical therapies for chronic pain. ARC-4588 is a 0.1% gel formulation of clondine hydrochloride administered topically. The drug produced top-line results from a phase 2b double-blind, randomized, placebo-controlled trial in adult patients with peripheral diabetic neuropathy. The drug will enter phase 3 studies.

With fast track designation the drug will most likely qualify for priority review.

"This Fast Track designation is an important recognition by the FDA of the potential for ARC-4558 to address the unmet need for better agents to control the pain involved in PDN, a serious condition,” said James Campbell, M.D., Chief Executive Officer of Arcion, in a press release. “Having the Fast Track designation will be of great value to Arcion as we work with the FDA to come to an agreement on the final Phase 3 program, as well as open the way to a potential priority review.”