Since the early days of the pandemic, researchers have been trying to use old drugs for new tricks, raising hopes and spurring controversy. Some of these, like hydroxychloroquine, turned out to be flops, while others are still debated. Recently, another old drug called fluvoxamine has come onto the scene. MedPage Today explores how the old antidepressant has made its way to the COVID spotlight.
Fluvoxamine and the COVID Early Treatment Fund
Fluvoxamine is the poster child of the COVID-19 Early Treatment Fund (CETF). According to its founder, serial tech entrepreneur Steve Kirsch, CETF was started in April 2020 in order to fund drug repurposing research to find the fastest and most cost-effective early outpatient treatments for COVID-19. Kirsch told MedPage Today that his efforts are purely humanitarian — almost no one was supporting this kind of research, so he stepped up to the plate.
“People have accused me of doing it out of my own self-interest. I can tell you I have done nothing but lose money on this endeavor,” he said in an interview. “Pure charity, there really isn’t a way to profit from this.”
Kirsch, whose net worth totals about $230 million, was diagnosed with waldenstrom’s macroglobulinemia in the past and has funded research for that rare blood cancer through other philanthropic efforts. He has a bachelor and master of science in engineering from MIT.
He says he has raised $5 million for CETF, starting with a tax-deductible bolus of $1 million of his own money. The biggest donors have been the Skoll Foundation ($1 million) and the Flu Lab ($1.3 million), according to an email from Kirsch. Both the Skoll Foundation and the Flu Lab were contacted by MedPage Today for comment, and did not respond.
The CETF has assembled a scientific advisory board with 12 members from academic institutions including Johns Hopkins University, Harvard Medical School, and Northwestern University. Kirsch says that the scientific advisory board has reviewed 110 grant applications so far, and has funded 14 of them.
One of these applications was for fluvoxamine in the early treatment of COVID-19, submitted by Eric Lenze, MD, a psychiatrist at Washington University in St. Louis, who is now principal investigator on a fluvoxamine trial called STOP COVID, with preliminary results published last fall in JAMA.
Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that is used primarily to treat obsessive compulsive disorder in adults and children ages 8 and up. It was first FDA approved in 1994, and was sold in the U.S. under the brand name Luvox until 2002. Luvox was taken off the market in the U.S. following reports that one of the Columbine shooters, Eric Harris, had been taking the drug at the time of the tragedy. Generic fluvoxamine continues to be available in the U.S.
Overall, fluvoxamine appears to be well tolerated, although it has the potential to precipitate manic episodes in susceptible people. Like all members of its class, fluvoxamine has a long list of potential drug-drug interactions, and carries a black box warning for suicidal ideation in children, adolescents, and young adults. There is also a risk for QTc prolongation and rare but potentially deadly serotonin syndrome. There has been at least one case report of acute fluvoxamine toxicity and death.
Kirsch says that earlier stage studies of fluvoxamine as a possible anti-inflammatory were convincing enough for the CETF scientific advisory board to fund Lenze’s preliminary study. Results published in JAMA indicated that clinical deterioration occurred in 0% (0/80) of COVID-19 patients randomized to fluvoxamine compared with 8% (6/72) on placebo (P=0.009).
However, the study relied upon patient self-report and self-measurement of symptoms. Lenze (who reports consulting fees from Jazz Pharmaceuticals, the maker of Luvox CR) and colleagues acknowledge that they…