NE Florida News

Jacksonville doctor Matthew Braddock credits Aviptadil with turning the table for a 20-year-old patient suffering from COVID-related lung damage.

Braddock, a primary care doctor working at Baptist Health, estimates he has treated 500 COVID patients but had never witnessed a case like this one.

His patient was suffering from a lung malady developed after contracting COVID.

“This kid was borderline needed to go on a ventilator,” Braddock told NE Florida News.

The patient had lost his father only a week before going into the hospital himself.

“His father passed away from it, and I am talking to the mom and she is obviously deathly afraid she is about to lose her son as well and I was too,” Braddock said. “Outside of being his doctor, I’ve known them for 25 years, the family. We were thinking we were going to be burying another one. I just kept looking at all of the new stuff coming down the pipeline.”

Braddock said the outcome was looking bleak for his patient when he gained authority to prescribe him Aviptadil.  

He said after applying Aviptadil his patient had the quickest recovery he’d ever witnessed.

“I’ve never seen anyone get better that quickly, that miraculously, on a medication,” Braddock said.  

The patient went home three days after taking the medication whereas five weeks before he had very low oxygen saturation in his lungs.

“He has been doing great at home now from what I understand,” Braddock said.

Aviptadil is marketed under the brand name Zyesami by pharmaceutical company NeuroRX.

The pharmaceutical has been used for the past two decades as an erectile dysfunction treatment. But its more immediate use is for COVID relief, particularly in those who emerge from infection with severely damaged lungs.

Braddock said he is advocating for others to have a right to try the medicine.

“I have discussed it with our critical care doctors at the hospital and with the family as well to push them to get this approved under the Right to Try Act,” Braddock said.  

The patient had gone through all treatment options by the time they landed on Aviptadil.

“He just wasn’t improving -- 0% improvement,” Braddock said.

Braddock said he pestered the lung specialist to allow for the prescription.

“The patient failed everything we had available to them and that completely turned him around. It was very miraculous to see,” Braddock said.

Some are saying Aviptadil — as a COVID treatment  — could save lives but is being held back from the population at large.

“It definitely reaffirms some of the data that is out when you can see it work on patients,” Braddock said.

Other users — such as Miami doctor Dr. Jacobo Elgozy who saw an immediate recovery himself after receiving Aviptadil — back up Braddock’s account, saying Aviptadil offers COVID relief and saves lives.  

Earlier this year, NeuroRX partnered with Relief Therapeutics to adapt Aviptadil for use in COVID patients due to the inflammation relief it offers.

In September 2020, NeuroRX applied for emergency use for COVID patients with respiratory issues.

In February, NeuroRX said a final trial was showing positive results.

NeuroRX CEO Dr. Jonathan Javitt said the company was encouraged by early findings.

In a 196-patient review, those using Aviptadil were found to be released from the hospital a full five days earlier than their counterparts who did not receive the medication.

“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 at the time. “This is the population where Remdesivir and other drugs didn’t work, and yet we’ve seen a difference in this very population.”

Javitt was excited about the possibilities at the time.

"The data provide preliminary support for Zyesami as a drug that may help get critically ill patients home to their families sooner,” he said.

Following the news, the National Institutes of Health opened a Phase 3 trial into the use of Aviptadil for treating COVID infections.

The NIH announced in August that its Data Safety Monitoring Board "found no new safety concerns" in its ongoing trial involving 140 patients.

However, the drug is still languishing in FDA review and has not been released, even for emergency use.

Last year, NeuroRX, a company based in the U.S. and Israel, partnered with Relief Therapeutics to develop Aviptadil in the U.S. for use in COVID-19 patients suffering from respiratory issues.

In September 2020, under the brand name ZYESAMI, NeuroRX applied for emergency use authorization from the U.S. Food and Drug Administration for COVID-19 patients in intensive care.

Research shows the drug, otherwise known as RLF-100, protects the lung cells attacked by the SARS-CoV-2 virus, decreasing lung inflammation.

In April, the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) and National Heart, Lung and Blood Institute (NHLBI)  announced a Phase 3 trial of Zyesami.

The FDA has thus far failed to act in offering Aviptadil to COVID patients.