Glenmark Pharmaceuticals and Canada-based SaNOtize Research & Development have introduced the Nitric Oxide Nasal Spray (NONS) to treat Covid-19 in adult patients in India.
To be marketed under the brand name FabiSpray, the treatment is intended for Covid-19 patients at increased disease progression risk.
The latest development comes after Glenmark obtained manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS under the accelerated approval process.
FabiSpray has been designed to destroy the SARS-CoV-2 virus that causes Covid-19 in the upper airways.
Furthermore, the spray has established anti-microbial properties with a direct virucidal effect on the virus.
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When applied over nasal mucosa, the spray works as a physical as well as a chemical barrier against the virus, thereby averting the viral incubation and spreading to the lungs.
In a Phase III clinical trial carried out in adult Covid-19 patients in India, a statistically significant and superior decline in log viral load in the NONS arm was observed versus the placebo arm, meeting the primary endpoint.
The multicentre, parallel-arm, double-blind trial analysed the safety and efficacy of NONS against saline nasal spray enrolling 306 non-hospitalised patients across 20 clinical sites in the country.
NONS was found to be safe and well-tolerated and demonstrated a 94% decline in viral load in 24 hours and 99% in 48 hours.
The median time to virological cure was four and eight days in the NONS arm and the placebo arm, respectively.
In July last year, Glenmark and SaNOtize signed an exclusive long term strategic collaboration for producing, marketing and supplying NONS to treat Covid-19 in India and various other Asian markets.
Glenmark Pharmaceuticals chief commercial officer Robert Crockart said: “We are happy to receive regulatory approval for Nitric Oxide Nasal Spray (FabiSpray) and launch it in partnership with SaNOtize.
“This reaffirms our commitment of providing yet another safe and effective antiviral treatment for Covid-19, and we are confident it will offer patients a much needed and timely therapy option.”
In June 2020, Glenmark obtained regulatory approval to manufacture and market its antiviral drug Favipiravir for treating mild-to-moderate Covid-19.
