Researchers found that the experimental pill molnupiravir cut the chances of hospitalization or death by about 50 percent. A total of 7.3 percent of patients who received the drug were either hospitalized or died through day 29 of the trial compared with 14.1 percent of placebo-treated patients. While eight people who received the placebo died during the trial, there were no deaths at all among those receiving molnupiravir. For the trial, 385 individuals received the medication within five days of their coronavirus diagnosis, while a separate group of 377 who tested positive received a placebo. At study start, all patients were required to have at least one risk factor associated with poor disease outcome, such as hypertension, diabetes, or obesity. Merck, which worked with Ridgeback Biotherapeutics in the development of molnupiravir, ended trial recruitment early due to the positive results. Based on these findings, Merck plans to apply as soon as possible for emergency use authorization from the U.S. Food and Drug Administration (FDA). If authorized, molnupiravir could become the first oral antiviral medication for COVID-19. The company will also be submitting applications to regulatory bodies worldwide to begin marketing the pill. The news release on the drug did not specifically say whether the study found the drug to be safe. The Wall Street Journal said on Friday that molnupiravir could become a kind of Tamiflu for COVID-19, a medication that can be dispensed to patients when they first develop symptoms. When molnupiravir will become available to the general public is still unclear, but William Schaffner, MD, an infectious disease specialist and professor of preventive medicine and health policy at the Vanderbilt University School of Medicine in Nashville, Tennessee, expects the FDA may grant emergency authorization in the next 8 to 10 weeks. “The drug hasn’t been approved yet but this could be a very important new therapy for early COVID disease,” said Dr. Schaffner. “Pills are so much easier to administer than the current monoclonal antibodies, which of course require injections and intravenous infusions.” Robert Shafer, MD, a professor of medicine at Stanford University in California, who specializes in the treatment of infectious diseases, points out, however, that top-line data of monoclonal antibodies show so far that they are more effective at preventing hospitalization. Phase 3 results from clinical trials of remdesivir (brand name Veklury) indicated that the monoclonal antibody was 87 percent effective at reducing hospitalizations in high-risk patients who were diagnosed early. “I think the recommendations for high-risk individuals are likely to still be monoclonal antibodies, but there will be a lot of careful looking into the data in the next few weeks, especially as this goes to the FDA for emergency use authorization to try to figure out who should get monoclonal antibodies and who can just get oral molnupiravir,” said Dr. Shafer. He added that this oral treatment would be “truly lifesaving” in countries that don’t have access to more expensive, monoclonal antibodies. “Monoclonal antibodies require intravenous infusion, so logistically, they’re much harder to deliver,” said Shafer. “So I would put this in the game-changer category.”
