Topical Gel to Treat Diabetic Neuropathy Proves Successful in Phase 2

JULY 21, 2010
A phase 2b double-blind, randomized, placebo-controlled clinical trial, involving topical gel candidate ARC-4558 for adults with painful diabetic neuropathy produced effective results in relieving the pain.

The gel is produced by Arcion Therapeutics, a biotechnology company that develops topical therapies for chronic pain. The gel, ARC-4558, is poised to enter phase 3 studies. It contains a 0.1% gel formulation of clonidine hydrochloride that is administered topically. The gel targets abnormal nerve signaling at the skin level and was found to be most effective in reducing pain in subjects with evidence of preserved nociceptors in the skin. The more nociceptors present in the skin, the more significant the response was. There were no serious side effects reported.

“The top-line data reported today for ARC-4558 provide strong support for Arcion's fundamental approach of applying therapies topically to relieve neuropathic pain by targeting nerve signaling at the level of the skin,” said James Campbell, M.D., president and CEO of Arcion, in a press release. “Through this study, we identified a simple, predictive clinical test to identify non-responders to ARC-4558, which should enable us to optimize subject enrollment in future studies. Based on our successful End of Phase 2 meeting with the FDA, we believe ARC-4558 will be the first PDN treatment indicated to treat patients who have demonstrable functional nociceptors in the skin. The full Phase 2b results will be submitted for future peer review and we look forward to advancing the ARC-4558 program in Phase 3 studies.”

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