- The FDA approved a coronavirus trial of a drug that’s used to treat erectile dysfunction, among other things.
- The drug showed promise in treating ARDS, a common COVID-19 complication for severe cases that require ventilation therapy.
- If the trial is successful, the drug could be used to treat up to 100,000 critical cases.
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One of the problems with highly contagious new viruses like the SARS-CoV-2 that causes COVID-19 is that there’s no line of treatment when the outbreak starts. Doctors in China and other countries have tried all sorts of therapies to mitigate the effects of the novel coronavirus on the body. They’ve been using existing drugs that have been approved for other ailments, to treat symptoms, speed up recovery times, and attempt to save critical patients. That’s because it takes time to develop a drug that can deal with the new virus, just as it takes time to come up with a vaccine that could immunize the general population.
All sorts of substances have been tried to mitigate infections and kill the virus, including antiviral therapies for HIV, anti-malarial drugs, and medicine that treats heart disease, to name just a few. The latest addition to the list is a drug called Aviptadil (VIP) that’s used to treat erectile dysfunction, among other things.
The drug is supposed to be used to stop the acute respiratory distress syndrome (ARDS) that develops in severe COVID-19 cases and kills about 50% of patients. ARDS is a respiratory failure that can follow the severe lung inflammation affecting certain categories of patients, including the elderly and those people suffering from other medical conditions. These patients often need to be intubated and ventilated with a machine, while a secondary ECMO may help oxygenate the blood. Not all patients who are given oxygen therapy and who’re placed on ventilators are guaranteed to survive.
Therefore, VIP could be one of the last lines of defenses against the novel coronavirus in those cases where significant complications appear, like sepsis.
The Food and Drug Administration (FDA) has issued a “study may proceed” letter for two companies to go forward with a Phase 2 trial with the drug, according to Jewish Press. These are US-Israeli pharmaceutical firm NeuroRx and Swiss drug development company Relief Therapeutics.
“In a previous trial of VIP for ARDS caused by sepsis, seven out of eight patients on mechanical ventilation showed substantial improvement, and six ultimately left the hospital alive,” NeuroRx CEO Prof. Jonathan Javitt said. “Patients on ventilators for COVID-19 have only a 50 percent chance of survival.”
“If the early results can be replicated in ARDS caused by COVID-19, this treatment could have a major impact both on COVID-19 survival, and on the availability of ventilators for those in desperate need.”
The drug has been used for 20 years in trials for sarcoidosis, pulmonary fibrosis, and pulmonary hypertension. It was approved for the treatment of acute lung injury, and it’s used to treat erectile dysfunction in Europe.
Javitt said that should the trial demonstrate efficacy, Relief will have enough supply to treat 100,000 Americans.
At the time of this writing, the US had nearly 190,000 confirmed cases, including more than 4,000 deaths. Not all patients who are diagnosed COVID-19 positive will experience symptoms, and many will not need to be treated in hospitals or receive oxygen therapy.