Glenmark has secured accelerated approval from India’s drug regulator for manufacturing and marketing Nitric Oxide Nasal Spray (NONS)
India-based Glenmark Pharmaceuticals, in partnership with Canada’s SaNOtize, has rolled out its nitric oxide nasal spray in India, under the brand name FabiSpray, to treat Covid-19 in adults.
The Indian pharmaceutical firm has already received accelerated approval from the Drugs Controller General of India (DCGI) for manufacturing and marketing its Nitric Oxide Nasal Spray (NONS).
FabiSpray is designed to destroy the Covid-19 virus in the upper airways and has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2.
When sprayed over nasal mucosa, the NONS would serve as a physical and chemical barrier against the virus and prevent it from spreading to the lungs, said the company.
Glenmark Pharmaceuticals chief commercial officer Robert Crockart said: “As a leading pharmaceutical player, it is important that we are an integral part of India’s fight against the Covid-19 pandemic.
“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 July 2021, Glenmark entered into an exclusive long term strategic partnership agreement with Canadian biotech firm SaNOtize.
The collaboration was aimed at manufacturing, marketing and distributing its NONS product to treat Covid-19 in India and other Asian markets.
Other Asian markets include Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste, and Vietnam.
Glenmark has already received CE mark approval for the NONS in Europe, based on which SaNOtize can launch the product in the EU.
NONS is also approved and marketed in Israel, Thailand, Indonesia and Bahrain, under the name enovid or VirX, and is approved in many counties.
Glenmark Pharmaceuticals senior VP and clinical development head Monika Tandon said: “The results from this Phase 3, double-blind, placebo-controlled trial are encouraging.
“Demonstration of reduction in the viral load has a significant positive impact from a patient and community perspective.
“In the current scenario, with new emerging variants exhibiting high transmissibility, NONS provides a useful option in India’s fight against Covid-19.”
In March 2021, clinical trials conducted by SaNOtize showed that NONS was a safe and effective antiviral treatment against SARS CoV-2.
In the India Phase 3 trial, the therapy reduced 94% viral load in 24 hours and 99% in 48 hours, which was similar to the reduction seen in the UK NHS trial conducted by SaNOtize.