Generics
Apotex Corp to evaluate FDA approved fluvoxamine tablets for mild-to-moderate COVID-19 in outpatients
8 October 2021 -

Generic pharmaceutical company Apotex Corp Thursday awarded 25,000 fluvoxamine tablets and placebo tablets to the Duke Clinical Research Institute for the ACTIV-6 clinical study funded by the National Institutes of Health (NIH) to evaluate repurposed medications in the search for effective, safe treatments for mild-to-moderate COVID-19 for non-hospitalized patients.

ACTIV-6 is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding up development of the most promising treatments and vaccines for COVID-19.

According to the company, fluvoxamine is among existing FDA-approved medications chosen for ACTIV-6 to further evaluate its effects on mild-to-moderate COVID-19.

In conjunction, NIH plans to establish whether the anti-inflammatory effects of fluvoxamine observed in nonclinical studies are seen in COVID-19 clinical studies. Many small-scale studies have shown positive therapeutic benefits of fluvoxamine, including a recent Canadian study that saw fluvoxamine curb the number of COVID-19 patients ending up in hospital by 30%.

Additionally, ACTIV-6 is a double-blind study expected to enrol nearly 15,000 participants. Potential participants are at least 30 years old, have tested positive for COVID-19 and are experiencing symptoms. The participation involves taking the medication and keeping track of symptoms over 90 days through online surveys, concluded the company.

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