Therapy Areas: Central Nervous System
Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm
23 March 2022 - - US-based Virpax Pharmaceuticals, Inc (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, has 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 of the knee, the company said.

The key Investigational New Drug Application -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 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.

Virpax Pharmaceuticals is developing Epoladerm (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.

The company's proprietary technology is intended to provide a convenient aerosol canister for application of the spray film to the knee. The resulting film is intended to be thinner than a standard liquid bandage, visibly clear and fast drying.

The spray formulation is intended to avoid the inconvenient and messy application of creams or gels to the knee.

Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms.


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