Friday, March 26, 2021

Xlear Submits COVID-19 Pre-Emergency Use Authorization Request with FDA Regarding Use of Xlear Nasal Spray in Help in Combating SARS-CoV-2

 WASHINGTON-Thursday 25 March 2021 [ AETOS Wire ]

(BUSINESS WIRE)-- 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.

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Jeff Gulko


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