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FDA refuses to approve a common antidepressant as a COVID treatment

Signage is seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, the United States, August 29, 2020. REUTERS/Andrew Kelly/File Photo

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May 16 (Reuters) – The US Food and Drug Administration has decided not to approve the antidepressant fluvoxamine as a treatment for COVID-19, saying data had not shown the drug to be an effective therapeutic to fight the virus may be.

“Based on a review of the available scientific evidence, the FDA has determined that there is insufficient data to conclude that fluvoxamine may be effective in treating unhospitalized patients with COVID-19 to slow the progression of serious illness and/or prevent hospitalization,” the agency said in a document released Monday.

professor dr David Boulware of the University of Minnesota submitted the Emergency Use Authorization Request to the FDA that would have allowed physicians to prescribe fluvoxamine maleate to treat COVID-19 in out-of-hospital patients.

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Generic belongs to an old, widely used class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.

Boulware said his request is less urgent with the availability of drugs like Pfizer Inc.’s (PFE.N) Paxlovid, but he still believes the data supports the drug’s use in some COVID patients.

‚ÄúThere are effective therapeutics that are available. But not everyone has access to them. Not everyone can tolerate them. Some people have contraindications,” Boulware said in an interview. “And when you go to other countries in the world, to low- and middle-income countries, they don’t have access to therapeutics.”

Boulware’s submission drew on data from three studies, specifically a study of 1,497 non-hospitalized COVID patients in Brazil.

While the Brazilian study met its primary endpoint, showing an approximately 30% reduction in hospitalizations in the group that received fluvoxamine, the FDA said there were uncertainties about the assessment that reduced the number of emergency room visits by more than 6 hours.

Boulware said the FDA used a different measure to count hospitalizations in other drug trials, including only acute care treatments that lasted at least 24 hours.

“The standard they held for fluvoxamine was a different standard than the other big pharma studies of Paxlovid and (Merck’s) molnupiravir and the monoclonal drugs,” he said of other approved COVID therapeutics.

“I was really quite disappointed that they did that,” he said.

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Reporting by Leroy Leo in Bengaluru and Michael Erman in New Jersey; Edited by Bill Berkrot

Our standards: The Thomson Reuters Trust Principles.

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