Marin drug company develops coronavirus nasal spray

Parnell Pharmaceuticals in San Rafael is seeking approval from the U.S. Food and Drug Administration to market a nasal spray to prevent coronavirus infection.
The private company is seeking the FDA’s approval to conduct clinical trials on large groups. It has asked for emergency use authorization in the meantime. A meeting with the FDA is scheduled for next month.
“We’ve not actively promoted it yet,” said Dr. Frank Parnell, who co-founded the company in 1986 with his wife, Dr. Diana Parnell. “We did make pilot batches. We have some people using it.”
Parnell is a retired nose and throat surgeon, and his wife is a dermatologist. They are graduates of Georgetown University School of Medicine and completed residency training at the University of Wisconsin at Madison.
The major ingredient in the product, pentetic acid, is used in more than 150 cosmetic products. It has been approved by the FDA for use by nebulizer or intravenous injection as a treatment for people who have been contaminated by radioactive plutonium, americium or curium.
Parnell said the company must get FDA approval before it can make any claims about the spray’s effectiveness as a preventative for coronavirus. Nevertheless, the company is already selling the product on its website under the name Pretz-MD.
In addition to pentetic acid, Pretz-MD also contains yerba santa, one of the key ingredients in the company’s main product, Pretz Spray, a moisturizing nasal spray. Also known as bearsweed, yerba santa is a plant indigenous to the foothills of the Pacific Northwest that has been used as an herbal remedy by Native American tribes.
Parnell said Pretz Spray has been approved by the FDA as a “class I” medical device. The FDA defines class I devices as those “not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”
Class I devices are subject to far fewer regulatory requirements than class II or III devices.
On its website, the company says that Pretz-MD kills 99.9% of human coronavirus and antimicrobial resistant bacteria and fungi such as MRSA-1 in vitro.
Dr. Lisa Santora, Marin’s deputy public health officer, said while there is increasing interest in the use of nasal sprays as a means of protecting against the coronavirus, there is insufficient evidence that Pretz-MD is either safe or effective.
“While there is some biological plausibility, there isn’t clear evidence yet,” Santora said. “We really rely upon the FDA providing its approval and clearance. This product does not seem to be there yet.”
Santora said that even though the FDA has approved pentetic acid for some uses, that doesn’t mean it is necessarily safe for other uses.
“You are introducing a chemical agent into your nose,” Santora said. “Depending on the dosing of it, how concentrated it is, some people could have harm, anywhere from mild irritation to a severe allergic reaction.”
Earlier this month, the results of a small study showing that a nasal spray prevented the absorption of the coronavirus when tested on ferrets gained wide attention. The study was conducted by scientists from Columbia University Medical Center in New York, Erasmus Medical Center in the Netherlands and Cornell University in Ithaca, N.Y.
“It is valuable in controlled research environments to have people think outside of the box, especially when we’re looking at very costly treatments,” Santora said. “Are there things upstream that can be more preventative?”
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Santora said given the data showing the increased risk that people with diabetes face from coronavirus, healthy eating and regular exercise might be the most effective preventatives available.

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