Glenmark Pharmaceuticals Limited (Glenmark) – a global, innovation-driven pharmaceutical company and Canadian pharmaceutical company SaNOtize Research & Development Corp. announced the launch of its Nitric Oxide Nasal Spray under the brand name FabiSpray® in India; for the treatment of adult patients with COVID-19 who have a high risk of progression of the disease. Glenmark earlier received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS as part of the accelerated approval process.
FabiSpray, Nitric Oxide Nasal Spray, is designed to kill the COVID-19 virus in the upper airways. It has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2. NONS, when sprayed over nasal mucosa acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs.
Commenting on the significance of this development, Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd. 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 to 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.”
Dr Monika Tandon, Senior VP & Head – Clinical Development, Glenmark Pharmaceuticals Ltd., commented: “The results from this Phase 3, double-blind, placebo-controlled trial are encouraging. Demonstration of reducing 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 from its innovator, SaNOtize showed NONS was a safe and effective antiviral treatment of SARS CoV-2. In the first 24 hours, NONS reduced the average viral load by around 95%, and then by more than 99% within 72 hours. (In the India Phase 3 trial, a reduction of viral load of 94% in 24 hours and 99% in 48 hours was similar to decline seen in the UK NHS trial conducted by SaNOtize). NONS has been tested in healthy volunteers and patients as part of Canada and UK clinical trials. SaNOtize has an ongoing global Phase 3 prevention trial, further adding to its efficacy. As per studies conducted in the Utah State University USA, NONS is proven to kill 99.9% of SARS-Cov-2 virus, including Alpha, Beta, Gamma, Delta, and Epsilon variants within 2 minutes.