June 14, 2011 -...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.About ARC-4558
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... [PDF] Arcion Therapeutics' Press Release -
