Virpax Pharmaceuticals Successfully Completes Pre-IND Meeting with FDA

Virpax Pharmaceuticals, which specializes in developing pharmaceutical products for pain management using novel drug delivery systems, has announced the successful completion of a pre-investigational new drug (IND) application meeting with the US FDA.

According to a May 21, 2020 press release, the pre-IND meeting was for Epoladerm (diclofenac epolamine) spray, which is being developed in partnership with MedPharm-a contract provider of topical and transdermal product design and formulation development services. Epoladerm is an investigational metered-dose topical aerosol containing diclofenac epolamine that is supplied in a pre-filled device and is suitable for topical administration to the knee.

At the pre-IND meeting, FDA agreed that it is reasonable for Virpax to pursue a 505(b)(2) new drug application (NDA) for Epoladerm. Additionally, it was suggested at the meeting that the proposed indication for Epoladerm, osteoarthritis of the knee, is acceptable.

As a result of the completion of the pre-IND meeting, Virpax is now planning for a Phase I pharmacokinetic study of Epoladerm in humans.

Source: Virpax Pharmaceuticals, MedPharm