American Fork-based Xlear Inc has filed a Pre-Emergency Use Authorization (Pre-EUA) request with the U.S. Food and Drug Administration (FDA) seeking approval to make claims that the company’s Xlear Nasal is approved for use in preventing SARS-CoV-2 (COVID-19) virus transmission and infection. The Pre-EUA is a first step in seeking formal authorization of nasal spray as a tool to help in combatting the coronavirus.
Xlear previously filed a pre-EUA seeking approval for use of the nasal spray as a medical device in combatting COVID-19. However, because the FDA determined that Xlear “works against the virus,” the FDA told Xlear it would need to be considered as a drug or combination product to receive an EUA.
“Seeing that the FDA says Xlear works against the virus, we have decided to seek EUA approval as a drug,” said Nathan Jones, Xlear’s CEO.
Xlear’s Pre-EUA request is based on recent studies showing the nasal spray is virucidal (it kills the virus); antiviral (it blocks the adhesion of the virus to the nasal membrane, which is how most people get sick from COVID-19); antibacterial against streptococcus bacteria, which is the leading cause of bacterial pneumonia; and it reduces both the duration and severity of illness when used to treat COVID-19 patients.
Xlear is currently sold in over 50,000 pharmacies, grocery stores and online as a nasal spray, Jones said.
“Xlear doesn’t require the EUA to be sold and used — we only need an EUA to be able to inform people about the benefits of using Xlear to protect themselves from COVID-19,” Jones said. “It’s insane. Without the EUA, the Federal Trade Commission won’t let us simply inform people about new, published, independent scientific studies. We hope to move forward quickly with FDA to address gaps in current prevention and treatment strategies against SARS-CoV-2. People should be using Xlear as part of a layered defense to prevent getting COVID-19.”