Contract Pharma Staff05.22.20
Virpax Pharmaceuticals, a company specializing in developing pharmaceutical products for pain management by using new drug delivery systems, successfully completed a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) for Epoladerm (diclofenac epolamine) spray. Epoladerm 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 of diclofenac epolamine supplied in a pre-filled device for administration as a topical spray film to the area of osteoarthritis of the knee.
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. 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 is now planning for a Phase I pharmacokinetic study of Epoladerm in humans. “We believe our proprietary metered-dosed delivery system could provide an effective tool in the management of osteoarthritis of the knee,” said Anthony P. Mack, chief executive officer, Virpax. “We are looking forward to moving ahead with our planned studies and executing on our clinical milestones given this accelerated regulatory pathway.”
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. 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 is now planning for a Phase I pharmacokinetic study of Epoladerm in humans. “We believe our proprietary metered-dosed delivery system could provide an effective tool in the management of osteoarthritis of the knee,” said Anthony P. Mack, chief executive officer, Virpax. “We are looking forward to moving ahead with our planned studies and executing on our clinical milestones given this accelerated regulatory pathway.”
