A petition has been launched pleading for the FDA to authorize Aviptadil for COVID treatments.
The Change.org petition has over 3,900 signers so far out of a goal of 5,000.
“There is clear and undeniable evidence that the drug ZYESAMI, also known as RLF-100 and Aviptadil, successfully treats severe COVID-19,” the petition reads. “There is growing public outcry for this therapeutic drug to be made more accessible to severe COVID-19 cases.
“Thousands of people each day are dying while the red tape of bureaucracy prevents this from being used. With a great safety profile, antiviral properties and lung protective and restorative properties, it is not only inhumane, (but) unethical and cruel for this drug to be held up from being used.”
The authors of the petition point to a study conducted at Houston Methodist Hospital that found the treatment highly effective in a group of 21 co-morbid patients, who experienced positive results from Aviptadil when no other treatments work.
Subsequent research has backed up that early account.
Pharmaceutical company NeuroRX markets Aviptadil under the brand name Zyesami. It has been in used for two decades to treat erectile dysfunction but is not yet approved to treat COVID.
Research indicates Aviptadil decreases lung inflammation, thereby protecting lung cells.
Many have been calling for emergency use of the drug for COVID cases after some healthcare providers reported miraculous turnarounds in patients.
One of those, Dr. Matthew Braddock, of Jacksonville, Florida, was able to successfully treat a severe COVID case in a 20-year-old who suffered significant lung damage after contracting COVID.
“I’ve never seen anyone get better that quickly, that miraculously, on a medication,” Braddock told NE Florida News.
Braddock is advocating for FDA emergency usage of the medication and has spoken to other doctors at his hospital about prescribing it.
“It definitely reaffirms some of the data that is out when you can see it work on patients,” Braddock said.
Similarly, Dr. Jacobo Elgozy was taking care of a patient when he came infected.
He said his lungs were non-functional, and he was up for a lung transplant when his doctor thought of using Aviptadil.
“In a matter of two weeks-plus, I recovered like this (snapping his fingers),” Elgozy said. “My lungs started responding like there was no tomorrow.”
NeuroRx CEO Dr. Jonathan said the drug is showing remarkable success.
“With the drug, we saw a 70% or greater survival,” Javitt told WSVN-TV. “But in these patients who have no alternative, who have very little to look forward to, we believe (in) the experience that was seen in Houston and seen now around the country.”
A Phase 3 trial of Zyesami is ongoing.
In February, NeuroRX said a trial was showing positive results. Javitt said the company was encouraged by early findings in which patients receiving Aviptadil on average are being released five days earlier than those without.
“This is the first drug that’s really been introduced for people with critical COVID-19, for people who have respiratory failure and at the highest risk of dying,” Javitt told Patient Daily. “This is the population where Remdesivir and other drugs didn’t work, and yet we’ve seen a difference in this very population.”
The FDA has yet to act on NeuroRX’s application for the emergency use of Aviptadil for COVID patients. The company filed for authorization in September 2020.
