Michael Erman and Leroy Leo

(Reuters) – The U.S. Food and Drug Administration declined to approve fluvoxamine as an antidepressant to treat COVID-19. They stated that there is no evidence to support the claim the drug can be used to fight the disease.

“Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization,” the agency said in a document https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/EUA%20110%20Fluvoxamine%20Decisional%20Memo_Redacted.pdf published on Monday.

Professor David Boulware from the University of Minnesota submitted an emergency authorization to FDA. This would have permitted doctors to prescribe fluvoxamine maleate for COVID-19 treatment in patients who are not hospitalized.

This generic drug is part of an older, well-used antidepressant class called selective serotonin reuptake inhibits (SSRIs).

Boulware indicated that his request for drugs is not as urgent because of the availability drug like Pfizer Inc (NYSE:). Paxlovid still believes that data supports drug use in COVID patients.

There are many effective therapies that exist. However, not all people have access to these treatments. They may not be suitable for everyone. Boulware explained that certain people might have contraindications. “And they don’t have any access to treatment if you travel elsewhere in the world. This includes low- and medium-income countries.”

Boulware used data from three trials to support his submission, including a Brazil-based study of 1 497 COVID non-hospitalized patients.

The Brazilian study showed a drop of around 30% in hospitalizations for the fluvoxamine-treated group. However, FDA stated that there are uncertainties in this assessment. It measured a reduction in visits to emergency departments lasting over 6 hours.

Boulware claimed that FDA had employed a different method of counting hospitalizations in drug trials. It included only those that were less than 24 hours.

His comments about other COVID therapies were: “The standard they held for fluvoxamine wasn’t the same as the other big Pharma trials, Paxlovid (Mercks) Molnupiravir or the monoclonals.”

“It was very disappointing that they did that,” said he.