Xlear Submits COVID-19 Pre-Emergency Use Authorization Request with FDA Regarding Use of Xlear Nasal Spray to Help in Combating SARS-CoV-2
WASHINGTON--(Business Wire / Korea Newswire) December 09, 2020 -- Today, Xlear is filing a Pre-Emergency Use Authorization (Pre-EUA) Request with the U.S. Food and Drug Administration (FDA). The Pre-EUA is a first step in seeking authorization of Xlear Nasal Spray as a new hygiene tool to help in combat the SARS-CoV-2 virus, the virus that causes COVID-19.
Xlear’s Pre-EUA Request is based on initial data suggesting Xlear Nasal Spray may reduce SARS-CoV-2 viral load in the nose, and otherwise attenuate the virus. “Studies show that regular nasal cleansing may help reduce viral infections, including from the SARS-CoV-2 virus (COVID-19),” said Dr. Gustavo Ferrer, a doctor and global respiratory disease expert who has studied the use of Xlear Nasal Spray to combat SARS-CoV-2. “The concept is straight-forward: Cleansing the nose means less virus, less virus produces less risk of infection,” Dr. Ferrer added.
The Pre-EUA Request is focused on the cleansing uses of Xlear, however it follows on recent studies suggesting Xlear is both antiviral and virucidal against SARS-CoV-2:
· A clinical case study of three “[s]ymptomatic, COVID-19 patients, treated with [Xlear],” found “rapid clinical improvement and shorten[ed] time” to negative PCR tests. https://www.cureus.com/articles/43909-potential-role-of-xylitol-plus-grapefruit-seed-extract-nasal-spray-solution-in-covid-19-case-series.
· Xylitol, which is one of the Ingredients of Xlear, has been shown to have inhibitory properties versus SARS-CoV-2 in cell culture, in vitro. https://www.biorxiv.org/content/10.1101/2020.08.19.225854v1.full
· Later in vitro studies with Xlear suggested it might provide a “replicable means to deactivate SARS-CoV-2 . . . to an undetectable amount of infectious virus.” https://www.biorxiv.org/content/10.1101/2020.11.23.394114v1.full
The linchpin of FDA’s COVID-19 EUA determinations is a risk-benefit assessment — given the threat of a global pandemic, do the possible benefits of the emergency use, outweigh any known risks. Xlear has been used by millions of people over the last twenty years for cleansing and moisturizing the nasal cavities without a single report of a significant adverse event. At the same time, preliminary data shows Xlear has potential benefits versus SARS-CoV-2. “More research will be needed to confirm the effectiveness of Xlear versus SARS-CoV-2. However, we believe the available data clearly shows potential benefits outweigh any practically non-existent risks, ” said Nate Jones, CEO of Xlear. “We hope to move forward quickly with FDA to address a gap in current hygiene 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 drive SARS-CoV-2 infection rates down nationwide,” Jones added.
Xlear is currently sold in over 50,000 pharmacies, grocery stores, and online as a nasal irrigant for cleansing and moisturizing the nasal cavities.
More information on Xlear: https://xlear.com/
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