Topline
The Food and Drug Administration on Monday declined to authorize a cheap and widely available antidepressant as a treatment for Covid-19, finding that a study indicating the drug was effective against the disease was severely limited.
Preliminary data suggests that the antidepressant pill fluvoxamine may be effective against ... [+]
Key Facts
Fluvoxamine maleate—which is used to treat depression, obsessive-compulsive disorder and other conditions—also has anti-inflammatory properties, making it a possible treatment for Covid-19, which apparently inflicts many of its symptoms through inflammation.
The request for an FDA emergency use authorization for fluvoxamine was based mainly on a preliminary study published in January by the Lancet, which indicated that the drug reduced chances of hospitalization or six-hour emergency care visits by 32% among patients at heightened risk of severe Covid-19.
However, in a rare statement Monday explaining its decision to reject the application, the FDA said that study had design limitations, including a small sample size and a lack of randomization, making it unpersuasive as a case for fluvoxamine’s usefulness against Covid-19.
The FDA also questioned researchers’ decision to measure emergency care visits of six hours or longer, and said six hours may not be a clinically significant cutoff point.
Two other studies, one of which was much larger than the Lancet study, failed to show fluvoxamine was effective for adults with mild Covid-19, the FDA pointed out.
The emergency use authorization application for fluvoxamine was made December 21 by Dr. David Boulware, a University of Minnesota infectious disease specialist.
Contra
Though fluvoxamine has yet to be proven effective against Covid-19, the FDA concluded, some scientists said the preliminary Lancet study warrants further investigation. The drug is particularly of interest because it may be used to treat Covid-19 during early stages of infection as an alternative to relatively expensive and difficult-to-get monoclonal antibody treatments, Scripps Research Translational Institute Director Dr. Eric Topol told STAT.
Key Background
Fluvoxamine, marketed under the brand name Luvox, was approved to treat conditions including depression and obsessive-compulsive disorder in 2007. Since then, it has become widely available across the United States for about $4 for a 10-day course. Initial trial results in 2021 indicated that fluvoxamine could be effective against Covid-19, spurring interest in the drug. However, subsequent trials have yielded inconsistent results, and proven oral Covid-19 antivirals like Pfizer’s Paxlovid have emerged on the market since then. The Biden Administration has ordered 20 million courses of Paxlovid, and reportedly plans to make the drug available at pharmacies across the United States.
Further Reading
“Six Ways Fluvoxamine May Act To Prevent Severe Covid-19” (Forbes)
