FDA grants Arcion's ARC-4558 Fast Track designation for pain involved in Painful Diabetic Neuropathy

Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to for the treatment of pain associated with Painful Diabetic Neuropathy (PDN). ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration. Arcion recently announced positive top-line results from a Phase 2b double-blind, randomized, placebo-controlled clinical trial of ARC-4558 in adult patients with PDN. The Company also recently held an End of Phase 2 meeting with the FDA and the ARC-4558 program is now poised to enter Phase 3 studies.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs typically qualify for priority review, thereby expediting the FDA review process.

"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. "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."