24 March 2021 - - US-based xylitol-based products maker Xlear has filed a Pre-Emergency Use Authorization (Pre-EUA) Request with the US Food and Drug Administration seeking approval to make claims that the nasal spray is approved for use in preventing SARS-CoV-2 (COVID-19) transmission and infection, the company said.

The Pre-EUA is a first step in seeking formal authorization of Xlear Nasal Spray as tool to help in combatting COVID-19.

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 EUA.

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 (a COVID-19 complication linked to morbidity); and, 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.