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."
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