Berwyn-based Virpax Pharmaceuticals has decided to take the over-the-counter route toward regulatory approval for Epoladerm, its experimental pain treatment for osteoarthritis, writes John George for the Philadelphia Business Journal.
The pharmaceutical company’s new drug candidate is a topical spray film formulation of diclofenac, a non-steroidal anti-inflammatory drug.
The company opted for the OTC route in seeking approval for Epoladerm because it believes this will offer a quicker timeline for drug development and a faster approval track than the originally-pursued pathway for a prescription drug.
According to Virpax CEO Anthony P. Mack, the company believes that the drug’s once- or twice-daily spray could be a more efficient “hands-free alternative” to the currently available OTC topical diclofenac gel, which has to be applied four times.
Virpax plans to “validate Epoladerm’s claims and value” in North America, Europe, and Asia, said Mack.
Virpax will submit the data on Epoladerm’s toxicity, sensitization, irritation, and phototoxicity studies, as well as its pharmacokinetics characteristics, to the FDA to support its OTC application. The company also expects it will have to perform the required consumer preference assessment and a pivotal study as part of the process.
Read more about Virpax Pharmaceuticals in the Philadelphia Business Journal.