Merck said Monday it is seeking U.S. Food and Drug Administration emergency use authorization for its experimental antiviral COVID-19 treatment, molnupiravir.

If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight COVID-19. It comes in capsule form.

Merck said it is asking for authorization for the capsules to treat infected adults who are at risk of progressing to severe COVID-19 disease or hospitalization. Its submission is based on a study that was stopped at the interim point because the drug was working so well in more than 700 patients randomly assigned to take either molnupiravir or a placebo.

"At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients," the company said in a statement.

"Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo." None of the volunteers in the trial had been vaccinated.

"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," Merck CEO and President Robert Davis said in the statement.

Data from the trial has not yet been peer-reviewed or published.

"Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022," the company said.

It has already sold 1.7 million treatment courses to the U.S. government. The company said it will offer tiered pricing to provide access around the world, and will work with generic drug manufacturers to speed availability to low- and middle-income countries.

At a White House COVID-19 briefing last week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the trial results "very encouraging," but said the drug needs close scrutiny by the FDA.

"It is very important that this now must go through the usual process of careful examination of the data by the Food and Drug Administration both for effectiveness, but also for safety, because whenever you introduce a new compound, safety is very important," Fauci said, noting that vaccines remain "our best tools against COVID-19" by preventing infection and illness, rather than treating it.

An antiviral pill has shown to be effective in treating COVID-19, according to Phase 2 trial results released late last week.

Should those promising results continue in large-scale Phase 3 trials, the drug could become vital in the fight against COVID-19 — a disease that still has few treatment options for those suffering from mild to moderate cases.

The drug, molnupiravir, is being produced by Ridgeback Biotherapeutics, which is partnering with Merck in scaling up drug trials. While COVID-19 vaccines attack the spike proteins that give the viral cell their distinctive shape, molnupiravir attacks the reproduction centers of the cells, according to the Wall Street Journal.

The goal of the drug is to neuter the contagion so it can’t easily spread from person to person — and results of the drug’s Phase 2 trials appears to show it’s doing just that.

According to Ridgeback and Merck, 182 people were given either molnupiravir or a placebo within a week of developing symptoms of COVID-19, and within four days of a positive test. None of those who took the drug twice a day for five days were detected to have any infectious virus through nasal swabs, while 24% of those who received the placebo were recorded to have infectious virus.

In addition, Ridgeback Biotherapeutics co-founder Wayne Holman told the Wall Street Journal that the findings suggest — but don’t prove — that the drug can reduce illness.

While four “adverse events” were reported among subjects, none of them were linked to side effects of the drug.

“We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” said Dr. Wendy Painter, the chief medical officer of Ridgeback Biotherapeutics. “At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”

Currently, the Centers for Disease Control and Prevention has only approved a handful drugs approved to treat COVID-19. Remdesivir and Dexamethasone are only approved for use in cases of severe disease and hospitalization. Molnupiravir could potentially be a game-changer since it’s being tested for use with less severe cases of the disease.

It will likely be several months before molnupiravir is approved for widespread use — it still needs to fill and complete Phase 3 trials before the CDC and HHS can even review findings.