Virpax Switches to OTC Medical Device Pathway for AnQlar

Virpax Pharmaceuticals said it will seek FDA’s approval for its intranasal barrier product, AnQlar, as an over-the-counter (OTC) medical device. The company originally considered filing an OTC New Drug Application (NDA) for the product.

AnQlar is a positively-charged mucoadhesive polymer that binds electrostatically to negatively charged viruses such as SARS-CoV-2 and influenza. The molecule may have a dual mechanism of action — viricidal properties and inhibition of virus entry into cells, providing a barrier to viral infection.

“We expect the OTC non-prescription medical device pathway to provide a faster drug development timeline and global approval track than the OTC non-prescription [NDA] pathway that we had originally pursued for AnQlar,” said Virpax CEO, Anthony P. Mack.

For the OTC medical device application, Virpax said it expects to complete stability testing, human factors testing for medical devices, safety studies and supplementary in-vitro studies.