BALTIMORE, June 14, 2011 /PRNewswire/ -- Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, today announced that data from the Phase 2b trial of ARC-4558 for the treatment of pain associated with painful diabetic neuropathy (PDN) will be the subject of two poster presentations at upcoming medical meetings. The first poster will be presented at the American Diabetes Association's 71st Scientific Sessions, June 24-28, 2011, in San Diego, California. The second poster will be presented at the Peripheral Nerve Society 2011 Biennial Meeting, June 25-29, 2011, in Potomac, Maryland. ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration.
Arcion previously 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 U.S. Food and Drug Administration (FDA) granted Fast Track designation to ARC-4558 for the treatment of pain associated with PDN. The Company also held an End of Phase 2 meeting with the FDA and the ARC-4558 program is now poised to enter Phase 3 studies.
Topical Clonidine for Treatment of Painful Diabetic Neuropathy: a Randomized Double Blind Phase IIb Clinical Trial
Meeting: American Diabetes Association's 71st Scientific Sessions
Presenter: James N. Campbell, M.D. and William Schmidt, Ph.D.
Session Day / Time: Saturday, June 25, 2011, 10:00 a.m. to 7:30 p.m.
Additional showing: The poster will also be part of the "Pharmacologic Treatment of Diabetes-Diabetes Complications" tour session on June 27, 2011, 12:00 p.m. to 1:00 p.m.
Response to Topical Capsaicin Correlates with the Efficacy of Topical Clonidine as a Treatment for Painful Diabetic Neuropathy (PDN)
Meeting: Peripheral Nerve Society 2011 Biennial Meeting
Presenter: James N. Campbell, M.D.
Session Day / Time: Tuesday, June 28, 2011, 7:30 to 8:30 a.m. poster viewing and 3:15 4:30 p.m. poster walk-around
ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride (HCL) for topical administration to the painful area in order to manage the neuropathic pain associated with painful diabetic neuropathy (PDN). Topical clonidine, through its agonist effects on (a2)-adrenergic receptors, is believed to reduce pain in PDN via local actions on the nociceptors that innervate the affected skin. Based on the results of clinical trials to-date, Arcion believes that ARC-4558 has a level of efficacy comparable to systemic therapies in the target population, but with substantially fewer side effects. The 0.1% gel formulation avoids the treatment area limitations and undesirable aesthetic and skin reaction issues associated with analgesic patches. Furthermore, the ARC-4558 gel has been shown to provide analgesia without numbing or anesthetizing the skin.
About Painful Diabetic Neuropathy (PDN)
Neuropathy is a common complication of diabetes mellitus. According to 2008 estimates by the Centers for Disease Control and Prevention, nearly 18 million people in the United States are diagnosed with diabetes. Given a conservative estimate that 15% of people with diabetes have painful neuropathies, approximately 2.7 million Americans experience PDN. Patients with PDN often experience debilitating pain symptoms that affect day-to-day functioning and quality of life. How diabetes causes a length-dependent neuropathy is unknown. Arcion believes the PDN market is highly under-served by existing products and that there is a strong scientific rationale for developing a topical treatment for PDN that delivers analgesia in a way that avoids systemic side effects.
Arcion Therapeutics applies breakthroughs in neuroscience to advance the treatment of chronic pain. The company focuses on innovative topical treatments to provide pain relief with convenient application and reduced systemic side effects. Arcion's product pipeline comprises multiple candidates to treat neuropathic pain. www.arciontherapeutics.com
SOURCE Arcion Therapeutics, Inc.