ARC-4558 in diabetic painful neuropathy

Arcion Therapeutics, is a company developing topical therapies for chronic pain. On September 15 2010 the company 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).

Clonidine gel in fast track FDA

ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration. Arcion poduced positive results from a Phase 2b double-blind, randomized, placebo-controlled clinical trial of ARC-4558 in adult patients with PDN.

The Company held an End of Phase 2 meeting with the FDA and the ARC-4558 program is in september 2010 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.

."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."   

www.arciontherapeutics.com

September 2010, prof. dr. Jan M. Keppel Hesselink