Doctor Submits Fluvoxamine EUA Application to FDA
It took about 4 days for David Boulware, MD, MPH, to write the FDA emergency use authorization (EUA) application for fluvoxamine. Yes, a doctor wrote an EUA application -- a task that has typically been relegated to pharmaceutical companies -- and yes, it was for a generic drug that physicians could technically prescribe off-label.
But Boulware, of the University of Minnesota, who is involved in a trial that's investigating fluvoxamine and other repurposed drugs -- along with a handful of other doctors and researchers -- took it upon themselves to apply because they believe the data substantiate its use in COVID-19.
"The big thing is, the data [are] available," Boulware said in an interview, referring to two published randomized, double-blind, placebo-controlled trials. "There should be enough data that the FDA would approve this under the normal review process to add a new indication for the drug." He added that doctors may be "reluctant" to prescribe a drug off-label, or that "some health systems may have policies against it." "I think most providers would feel more comfortable doing it if that therapy were FDA approved for that indication," said Carolyn Bramante, MD, MPH, also of the University of Minnesota.
Boulware said two randomized controlled trials support the use of fluvoxamine in preventing disease progression. In November 2020, the STOP-COVID study, led by Eric Lenze, MD, of Washington University in St. Louis, was published as a preliminary communication in JAMA. It showed that none of the 80 outpatients in the fluvoxamine group had clinical deterioration, compared with 6 of the 72 outpatients in the control group. The TOGETHER trial, led by Brazilian researchers, included 1,497 COVID-19 positive outpatients with a risk factor for severe disease. Overall, those who took fluvoxamine spent less time in the emergency room and were less likely to transfer to the hospital than those who got placebo (RR 0.68, 95% CI 0.52-0.88).
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One of the main benefits of fluvoxamine is its decades-long safety track record. It's also easy and relatively inexpensive to manufacture, the researchers said... Like the antivirals, fluvoxamine's effects won't be variant-dependent, unlike some of the monoclonal antibodies that have been rendered useless in the face of Omicron. While the mechanism behind fluvoxamine's effects in COVID-19 isn't clear, one perspective published in Frontiers in Pharmacology posits that its sigma-1 receptor agonism has an anti-inflammatory effects. It also may reduce platelet activation, or increase melatonin, or act in other ways to help alleviate the "cytokine storm" brought on by COVID-19.
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The problem, Boulware said, is that fluvoxamine "is a generic medicine and so there's no big pharmaceutical company that's going to take the effort and the time to apply [for an EUA] because it's made by six different companies or so in the U.S., and it's an inexpensive, $5-to-$10-treatment-course, kind of medicine."
More..
https://www.medpagetoday.com/special-reports/exclusives/96431
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