h diabetic neuropathy. By applying the drug topically to the area of pain, systemic exposure is minimized, and hence, systemic side effects appear to be minimal. Moreover, this approach may be complementary to systemic approaches. We are now in the midst of an additional randomized, controlled Phase 2b trial to confirm the safety and efficacy of topical clonidine," said James Campbell, M.D., President and CEO of Arcion. "ARC-4558 is a result of Arcion's expertise in developing differentiated drugs through our understanding of the underlying biology of neuropathic pain."
Previously published research has shown that in neuropathic pain conditions such as PDN, the signal that triggers pain actually arises at the level of the skin. The data reported today for ARC-4558 provide further rationale for applying therapies topically at the site of the pain. From a treatment standpoint, this approach has the potential to offer multiple benefits over orally bioavailable or patch-based treatments including more convenient application, uniform coverage of the affected site, lower systemic side-effects and fewer drug interactions.
The abstract, titled, "Topical clonidine gel (ARC-4558) reduces pain caused by diabetic neuropathy: Results of a multicenter, placebo-controlled clinical trial," was authored by Claudia M. Campbell, Ph.D., Johns Hopkins School of Medicine; Bruce Stouch, Ph.D., BCS Consulting; Kerrie Brady, M.S., M.B.A., Arcion Therapeutics; Bill Schmidt, Ph.D., NorthStar Consulting LLC; and James Campbell, M.D., Johns Hopkins School of Medicine and Arcion Therapeutics.
About the Trial
The double-blind, placebo-controlled trial included 166 patients with chronic, bilateral, lower extremity, painful diabetic neuropathy. Patients were randomized to receive 0.1% or 0.2% topical clonidine gel or placebo gel, and remained on their existing pain management treatments. The gel wa
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