The Food and Drug Administration on Monday declined to allow a cheap and widely available antidepressant to treat Covid-19, noting that a study suggesting the drug was effective against the disease was severely limited.
Fluvoxamine maleate – used to treat depression, OCD and other conditions – also has anti-inflammatory properties, making it a potential treatment for Covid-19, which appears to cause many of its symptoms through inflammation.
The FDA’s Emergency Use Authorization application for fluvoxamine was based primarily on a preliminary study published by the in January lancetsuggesting the drug reduced by 32% the likelihood of hospitalization or six-hour emergency care in patients at increased risk of severe Covid-19.
However, in a rare statement Monday explaining its decision to deny the application, the FDA said the study had design limitations, including a small sample size and lack of randomization, which it used to argue for fluvoxamine’s usefulness against Covid-19. 19 made unconvincing.
The FDA also questioned the researchers’ decision to measure emergency care visits of six hours or longer, saying six hours may not be a clinically significant cut-off.
Two other studies, one of which was much larger than that lancet Study failed to show fluvoxamine effective in adults with mild Covid-19, FDA noted.
The Emergency Use Authorization Application for Fluvoxamine was filed December 21 by Dr. David Boulware, an infectious disease specialist at the University of Minnesota.
Although fluvoxamine has not yet been shown to be effective against Covid-19, the FDA concluded, some scientists said the preliminary lancet Study warrants further investigation. The drug is particularly interesting because it can be used to treat Covid-19 in the early stages of infection as an alternative to relatively expensive and difficult-to-obtain monoclonal antibody treatments, said Dr. Eric Topol, director of Scripps Research’s Translational Institute, told STAT.
Fluvoxamine, marketed under the brand name Luvox, was approved in 2007 to treat conditions such as depression and obsessive-compulsive disorder. Since then it has been widely available in the United States for around $4 for a 10-day course. Initial study results in 2021 suggested fluvoxamine could be effective against Covid-19, sparking interest in the drug. However, subsequent studies have yielded conflicting results, and proven oral Covid-19 antivirals such as Pfizer’s Paxlovid have since emerged. The Biden administration has ordered 20 million courses of Paxlovid and is reportedly planning to make the drug available in pharmacies across the United States.
“Six ways fluvoxamine may work to prevent severe Covid-19” (Forbes)