WASHINGTON--(BUSINESS WIRE)--#COVID19--Xlear 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 nasal spray is approved for use in preventing SARS-CoV-2 (COVID-19) transmission and infection. 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.

�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 (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. �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. It�s insane. Without the EUA, the Federal Trade Commission won�t let us simply inform people about new, published, independent scientific studies,� Jones added.

�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. If everyone used Xlear, in addition to taking other steps recommended by public health officials, we believe we could help the nation defeat COVID-19 faster,� Jones added.

More information on Xlear: https://xlear.com/

Contacts

Jeff Gulko

617.304.7339

jeff@thegulkogroup.com