Virpax Will Pursue Direct to OTC Pathway for Epoladerm™ for Pain Associated with Osteoarthritis

Virpax Will Pursue Direct to OTC Pathway for Epoladerm™ for Pain Associated with Osteoarthritis
CANNANNEW REPORT

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 (CNS) disorders and anti-viral indications, today announced that it will pursue a direct to OTC regulatory pathway for Epoladerm™, the Company’s product candidate to treat pain associated with osteoarthritis. The direct to OTC, non-prescription regulatory pathway is expected to provide a faster drug development timeline and faster global approval track than the prescription pathway the Company had originally pursued for Epoladerm. To support the OTC application, the Company plans to submit Epoladerm’s completed dermal toxicity, sensitization, irritation, phototoxicity studies and its PK characteristics to FDA. In addition, Virpax anticipates it will have to complete a consumer preference assessment and a pivotal study required by the FDA’s Office of Non-prescription Drugs. “We believe that Epoladerm’s potential once or twice daily spray dosing may be a more efficient and convenient hands-free alternative to the current OTC topical diclofenac gel which is dosed four times a day by hand onto the skin,” stated Anthony P. Mack, Chairman and CEO of Virpax. “Virpax intends to validate Epoladerm’s claims and value in North America, Europe and Asia,” Mack continued. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular-envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop two other product candidates. PES200 is a product candidate being developed…

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