Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm™

Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm™

Preparing Investigational New Drug Application for Submission Upon Completion of Canadian Clinical Study BERWYN, Pa.–(BUSINESS WIRE)–#pharma—Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management Post-Traumatic Stress Disorder, Central Nervous System disorders and anti-viral indications, completed all FDA required pre-clinical studies for Epoladerm™, Virpax’s investigational pre-filled topical spray analgesic product to manage chronic pain associated with osteoarthritis (OA) of the knee. The key Investigational New Drug Application (IND)-enabling studies completed included dermal toxicity, sensitization, irritation, phototoxicity and PK characteristics. Virpax is drafting FDA IND submission documents for Epoladerm that will include these pre-clinical studies. Additionally, in January 2022, Virpax announced a clinical trial agreement with Altasciences Company, Inc., to complete a first-in-human pilot study investigating Epoladerm for pain associated with OA of the knee. The pilot study will take place in Canada under a Clinical Trial Application (CTA) filing with enrollment of the first patient anticipated in 2022. Virpax plans to submit the results of the pilot study as part of its IND application. “Physicians commonly encounter patients with pain from osteoarthritis (OA). The American College of Radiology guidelines on OA, as well as clinical practice guidelines from the American Academy of Family Physicians and the American College of Physicians recommend topical non-steroidal anti-inflammatory drugs (NSAIDs) as first-line therapy before recommending oral NSAIDs,” stated Jeff Gudin, MD, Professor of Anesthesiology and Executive Vice President and Chief Medical Officer of Virpax. “Our internal research and development team, along with an extensive network of partners, has progressed Epoladerm through the IND-enabling studies. We believe our clinical studies will demonstrate that Epoladerm, which utilizes our unique spray film technology, will be a more effective and easier-to-use treatment for OA of the knee than what is currently available. We anticipate rapid progress toward the completion…

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Source : Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm™

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