Virpax Pharmaceuticals Successfully Completes Pre-IND Meeting with FDA

May 28, 2020

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.

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 PharmaceuticalsMedPharm