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Topical low dose clonidine gel to treat Diabetic Neuropathy: phase 2 results

A phase 2b double-blind, randomized, placebo-controlled clinical trial, involving topical gel candidate ARC-4558 for the treatment of painful diabetic neuropathy produced effective results in relieving the pain, according to a press release of the company in july 2010.

Clonidine gel for neuropathic pain produced by Arcion

The gel is produced by Arcion Therapeutics, a biotechnology company that develops topical therapies for chronic pain.

The gel contains a 0.1% gel formulation of clonidine hydrochloride that is administered topically. Clonidine transdermally has been mentioned more often in literature as a treatment for neuropathic pain. ^[1] The idea is nearly 15 years old...^[2] In this phase II trial no serious side effects seemed to be reported. The dose is very low and we wonder whether any dose finding has been done by Arcion.

“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. "

Data are not yet published and we do not have details of the trial design.

July 2010, Jan M. Keppel Hesselink, MD, PhD

Referenties

[1]: Li C, Sekiyama H, Hayashida M, Takeda K, Sumida T, Sawamura S, Yamada Y, Arita H, Hanaoka K. | Effects of topical application of clonidine cream on pain behaviors and spinal Fos protein expression in rat models of neuropathic pain, postoperative pain, and inflammatory pain. | Anesthesiology. | 2007 Sep;107(3):486-94.

[2]: Epstein JB, Grushka M, Le N. | Topical clonidine for orofacial pain: a pilot study. | J Orofac Pain. | 1997 Fall;11(4):346-52.