Virpax Pharmaceuticals (Nasdaq:VRPX) announced today that it will pursue a direct to over-the-counter (OTC) regular pathway for Epoladerm.
Berwyn, Pennsylvania–based Virpax designed the Epoladerm investigational pre-filled topical spray analgesic product for the non-addictive management of chronic pain associated with osteoarthritis (OA) of the knee.
According to a news release, the company expects the direct to OTC, the non-prescription regulatory pathway to provide a faster drug development timeline and faster global approval track than the prescription pathway the company had previously pursued.
Virpax intends to submit Epoladerm’s completed dermal toxicity, sensitization, irritation, phototoxicity studies and its PK characteristics to the FDA to support its OTC application. The company also expects that 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,” Virpax Chair and CEO Anthony P. Mack said in the release. “Virpax intends to validate Epoladerm’s claims and value in North America, Europe and Asia,” Mack continued.