Glenmark received manufacturing and marketing approval from India’s drug regulator for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process.
Phase 3 trial in India met the key endpoints and demonstrated reduction of viral load of 94% in 24 hours and 99% in 48 hours. NONS was safe and well tolerated in COVID-19 patients. Glenmark to market NONS under the brand name FabiSpray®.
MUMBAI, India, Feb. 9, 2022, Glenmark Pharmaceuticals Limited (Glenmark) – a global, innovation-driven pharmaceutical company and Canadian pharmaceutical company SaNOtize Research & Development Corp., today announced 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 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®
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.
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 reduction 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, which will further add 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 variant within 2 minutes.
Strategic Partnership with SaNOtize
In July 2021, Glenmark entered into an exclusive long term strategic partnership with Canadian biotech firm SaNOtize, to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.
Global Approvals for NONS
NONS has already received a CE mark in Europe, which is an equivalent of marketing authorization in case of a Medical Device. By virtue of the CE mark, SaNOtize has permission to launch NONS in the EU. NONS is also approved and being sold in Israel, Thailand, Indonesia and Bahrain, under the name enovid™ or VirX™. NONS is approved in many counties for protection against viruses including SARS COV-2.
About Glenmark Pharmaceuticals Ltd.
The company has been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the fourth consecutive year in a row, most recently in 2021. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index.
This article was shared with Prittle Prattle News as a Press Release.