Adamis Pharmaceuticals has submitted an application seeking fast-track designation from the US Food and Drug Administration (FDA) for Tempol to treat and prevent Covid-19.
Tempol is claimed to possess anti-inflammatory, antiviral and antioxidant activity.
It is expected to offer an unmet medical need due to its unique mechanism of action and safety profile.
Adamis obtained exclusive global rights of Tempol for specific licensed fields comprising respiratory diseases treatment including asthma, respiratory syncytial virus, influenza and Covid-19.
Presently, Tempol is being analysed in a double-blind, randomised, adaptive, placebo-controlled Phase II/II clinical trial in adult Covid-19 patients.
Limiting hospital admission is the primary endpoint of the trial.
Adamis Pharmaceuticals president and CEO Dr Dennis Carlo said: “Concerns have been expressed about potential safety questions for EUA approved antivirals such as mutagenesis and drug-drug interactions.
“We are thus applying for fast-track designation to the FDA to expedite the regulatory approval pathway for Tempol.
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