They explained that there was not enough adequate evidence of the drugs effectiveness for this purpose.
However, they said that more clinical trials may be warranted.
The FDA Submission
The submission was based on a trial in Brazil involving around 1,500 patients.
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Researchers gave each patient either a placebo or 100mg of fluvoxamine twice daily for ten days.
They also questioned whether the six-hour threshold was actually meaningful.
What Is Fluvoxamine?
Fluvoxamine was first introduced in Switzerland almost 40 years ago.
The FDA approved it in 1994, making it the firstSSRIapproved by the agency to treat obsessive-compulsive disorder.
Like any medication, fluvoxamine does have potentialside effects.
These include nausea, drowsiness, weakness, diarrhea, sweating, and sexual dysfunction.
Hence, researchers thought that fluvoxamine could have similarly been repurposed.
Dr. Boulware has responded to the FDA, describing their logic as being inconsistent.
However, he maintains that the evidence is there to suggest that it could be beneficial for some patients.
In contrast, fluvoxamine binds to the receptor that helps to regulate inflammation and immune signaling.
It was thought that this might help patients to recover, and avoid the need for hospitalization.
However, the sample size was small, with just 152 participants.
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McCarthy MW.Repurposing approach of fluvoxamine for COVID-19.Drugs Fut.
2021;46(10):813. doi:10.1358/dof.2021.46.10.3335978
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