Arcion Receives Notice of Allowance for US Patent for Novel Topical Lidocaine Formulation for Pain
BALTIMORE, Jan. 4, 2012 /PRNewswire/ -- Arcion Therapeutics, a clinical stage biotechnology company developing topical therapies for chronic pain, today announced that it received notice of allowance for a US Patent for its high strength gel formulation of topical lidocaine, ARC-2022. ARC-2022 is being developed by Arcion for pain associated with post-herpetic neuralgia (PHN) and shingles. ARC-2022 has been evaluated in a single-dose Phase 1 pharmacokinetic study in adult patients with PHN. The results indicated sustained delivery without requirement of a patch or skin-occlusion. No safety issues were identified.
"With ARC-2022 our goal is to deliver lidocaine to the skin without the requirement of an occlusive patch. With topical delivery, systemic toxicities and CNS side effects can be avoided and the abnormal pain signals are suppressed at the point of origination in the skin," said James N. Campbell, MD, President and CEO of Arcion. "Issues with presently available FDA products for the treatment of neuropathic pain include limited efficacy and frequent side effects. Patches can pose challenges to the patient, particularly when they must be applied over joints, feet, hands, hairy or sweaty skin, or areas such as the face where aesthetics come into play. We believe ARC-2022 is an excellent candidate to address a significant market need with a product that optimizes delivery directly to the painful skin without the need for a patch."
"This patent allowance represents the second patent in the last three months for our two topical chronic pain programs, ARC-2022 and ARC-4558. These products now have patent protection through 2029 and beyond," commented Kerrie Brady, COO of Arcion. "We are on track to advance ARC-4558 for painful diabetic neuropathy into Phase 3 studies and ARC-2022 into further Phase 1/2 studies in 2012. ARC-4558 has received fast-track status with the FDA."
ARC-2022 is a topical lidocaine being developed for the treatment of pain associated with post-herpetic neuralgia (PHN) and shingles. The product contains lidocaine 40% in a clear, water-based gel that can be applied directly to painful skin areas of the body, providing for high skin concentration without an occlusive patch.
ARC-4558 is a topical 0.1% clonidine gel being developed for the treatment of painful diabetic neuropathy (PDN). It is a clear, water-based, fast-drying gel that provides pain relief that rivals approved oral drugs. ARC-4558 has a minimal side-effect profile with low/undetectable systemic levels of clonidine with over 600 patients treated in clinical trials to date.
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 core technology is based on research which showed that in many neuropathic pain conditions, the signal that triggers pain actually arises at the level of the skin. This finding provides a strong biological rationale for developing topically delivered drugs to target the pain at the source - the pain receptors in the skin. Arcion's product pipeline comprises multiple candidates to treat neuropathic pain. www.arciontherapeutics.com