Virpax scores at the pre-IND meeting with FDA on Epoladerm for Knee Osteoarthritis

Virpax Pharmaceuticals has successfully completed a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) for Epoladerm™ (diclofenac epolamine) spray.

It noted in the press release that Epoladerm is being developed in partnership with MedPharm Ltd, the world leading contract provider of topical and transdermal product design and formulation development services.

Epoladerm is an investigational metered-dose topical aerosol of diclofenac epolamine supplied in a pre-filled device for administration as a topical spray film to the area of osteoarthritis of the knee, Virpax noted.

Virpax said that, in the meeting, the FDA agreed that it is reasonable for Virpax to pursue a 505(b)(2) New Drug Application (NDA) for Epoladerm, which is an abbreviated approval pathway allowing Virpax to reference safety and efficacy data of a reference listed drug. It was further indicated that the planned indication for Epoladerm osteoarthritis of the knee is acceptable, Virpax said.. Other guidance regarding study design was also provided.

MedPharm is working closely with Virpax to develop Epoladerm™ (NSAID spray film) an investigational spray film designed to deliver an NSAID transdermally via a metered-dose spray. The delivery system features a high level of adhesiveness, accessibility and skin drying and is based on MedPharm’s unique MedSpray® technology.

“MedSpray’s unique characteristics of optimal dosing and patient convenience offers clients new opportunities to develop products with existing actives to benefit patients,” said Prof. Marc Brown, MedPharm’s co-founder and Chief Scientific Officer.

Given this feedback, Virpax said it is now planning for a Phase I pharmacokinetic study of Epoladerm™ in humans. “We believe our proprietary metered-dosed delivery system (Epoladerm™) could provide an effective tool in the management of osteoarthritis of the knee,” said Anthony P. Mack, CEO of Virpax. He added that the company is looking forward to moving ahead with its planned studies and executing on its clinical milestones given this accelerated regulatory pathway.