Posted on 03/29/2021 9:43:50 PM PDT by SeekAndFind
WASHINGTON--(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.
More information on Xlear: https://xlear.com/
for those interested in the Science behind XClear’s Nasal spray as it relates to the Coronavirus. This is a report of the study results late January this year:
[EXCERPT]
EVANSTON, Ill.—(BUSINESS WIRE)—Jan 26, 2021—
A new in vitro study done collaboratively by Utah State University and Northwestern University finds Xlear components (grapefruit seed extract and xylitol) significantly eliminates SARS-CoV-2, the virus that causes COVID-19. The imaging research study component was performed at the BioCryo facility of Northwestern University’s NUANCE Center.
Using electron microscopy, we have visual evidence showing that xylitol and grapefruit seed extract (GSE) counters the virus. The GSE kills the virus, while the xylitol prevents the virus from attaching to the cell walls. The image shows SARS-CoV-2 viruses outside the cell and never attached, thereby preventing infection (Photo: Business Wire)
The study tested SARS-CoV-2 virus titers and LRV against a single concentration of Xlear nasal spray. According to the Study, “After a 25-minute contact time, the nasal spray reduced virus from 4.2 to 1.7 log10 CCID50 per 0.1 mL, a statistically significant reduction (P<0.001) of 2.5 log10 CCID50.” The Northwestern/Utah State Study is the newest in a string of studies to reach the conclusion that Xlear is effective against the SARS-CoV-2.
However, the study breaks new ground in two vital respects: “First, we conclude, in addition to countering SARS-CoV-2, Xlear is likely effective in preventing the spread of future H1N1 viruses, including the emerging SARS-CoV-2 variants, along with other viral epidemics. Given the more transmissible variants we now face, this is critical now,” said Professor Mark Cannon, Feinberg School of Medicine, Northwestern University. “Second, using electron microscopy, we have visual evidence showing that xylitol and GSE counters the virus. The GSE kills the virus, while the xylitol prevents the virus from attaching to the cell walls. The image (attached) shows SARS-CoV-2 viruses outside the cell and never attached, thereby preventing infection,” added Dr. Cannon. The study postulates that xylitol acts as a decoy target for SARS-CoV-2, preventing virus attachment to the core protein on the cell wall.
The collaborative study concludes: “Because there are no risk factors in using the X/GSE combination therapy, and [Xlear] nasal spray is over the counter available without prescription, and [Xlear] allows for comfortable long term mask wearing, adoption of this preventive anti-viral therapy should be encouraged.”
The full study results can be found here:
Full study: https://www.biorxiv.org/content/10.1101/2020.12.02.408575v3.full
Thanks !!
I have xlear and it helps a lot with nasal stuffiness.
Looks like I’ll be taking a dose of that before and after my dental cleaning tomorrow.
Xylitol is extremely toxic to dogs, so make sure to keep it away from them.
The company is going to have a fun time dealing with the FDA after putting out this advertisement. The fines are going to be in excess of anything the company has ever made.
A year or two ago, I read here on FR about Vicks “First Defense” nasal spray. It’s made by P&G in Germany and sold in the UK. You can buy it on Amazon, too. Since I started using it, I haven’t has a single cold. It seems to have similar virucidal properties.
p
I’ve been using this for a month -
Non racist math will be used to find a new serum and vaccine for covid. Equations like 2+2= will have a diversity of right answers with no one white racist answer. This will ensure that the covid vacine formula is non racist. Some people may have harmful side effects due to the variety of non racist numbers used and they may die, but Fauci says we can ‘t accept racism in either math or science. Even if many people died because of the non racist math, they should be proud that the the math used was non racist, which is a worthy cause worth dying for.
Great...now it will be even harder to find and more expensive. It was like trying to hunt down a roll of TP last year looking for Xlear.
“Great...now it will be even harder to find and more expensive. It was like trying to hunt down a roll of TP last year looking for Xlear”
I just ordered up a couple bottles. Amazon has the best price for the 1.5 oz bottle. I stopped using Flonase as I just read that it depletes zinc levels. Maybe in some small way this will help with stuffiness with the added Covid benefit.
Is it expensive enough to be considered a credible treatment?
(I’ve been using this for a month -)
You’ve been using this for a month and didn’t bring it to our attention?
Go stand in the corner for the rest of the day/s
> “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.”
Great find! I had heard of a nasal spray treatment and prophylaxis but hadn’t seen the test data. Huge bonus that it’s already approved OTC for other uses.
I’ll circulate this to some elderly who are at risk.
Thanks for posting!
You’re spraying a sugar alcohol up your nose.
I could see why that would kill all kinds of things.
Including some things you’d rather not kill off.
Damn - did I do that twice?
Available on Amazon; I just ordered some.
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