FDA Declines Emergency Use Request For An Antidepressant As COVID-19 Treatment

  • The FDA has decided not to authorize fluvoxamine, an antidepressant, to treat COVID-19. The agency that data has not shown the drug to be an effective therapeutic for fighting the virus.
  • "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may effectively treat non-hospitalized patients with COVID-19 to prevent progression to severe disease/or hospitalization," the agency said.
  • University of Minnesota professor David Boulware submitted the FDA emergency use authorization request that would have allowed doctors to prescribe fluvoxamine maleate to treat COVID-19 in non-hospitalized patients.
  • Boulware said the request is less urgent with the availability of drugs like Pfizer Inc's PFE Paxlovid, but he still believes the data supports the drug's use in some COVID patients.
  • Boulware's submission relied on data from three trials, especially a study of 1,497 non-hospitalized COVID patients in Brazil.
  • While the Brazilian study met its primary endpoint, showing a roughly 30% drop in hospitalizations in the group that received fluvoxamine, the FDA said there were uncertainties about the assessment. 
  • The results were primarily driven by a reduction in the emergency department visits lasting greater than 6 hours.
  • Boulware said FDA had used a different measure to count hospitalizations in other drug trials, including only acute care that lasted at least 24 hours.
Posted In: BriefsCOVID-19 CoronavirusBiotechNewsHealth CareFDAGeneral