Glenmark received manufacturing and marketing approval from DCGI for Nitric Oxide Nasal Spray
New Delhi: Mumbai based innovation-driven global pharma company Glenmark has launched Nitric Oxide Nasal Spray (FabiSpray) in India, in partnership with SaNOtize, for treatment of adult patients suffering from COVID-19.
Glenmark received manufacturing and marketing approval from India's drug regulator, Drugs Controller General of India, for Nitric Oxide Nasal Spray as part of the accelerated approval process.
"Phase 3 trial in India met the key endpoints and demonstrated reduction of viral load of 94 per cent in 24 hours and 99 per cent in 48 hours. Nitric Oxide Nasal Spray (NONS) was safe and well-tolerated in COVID-19 patients. Glenmark to market NONS under the brand name FabiSpray," reads the official statement.
The company claims that when the Nitric Oxide Nasal is sprayed over nasal mucosa it acts as a physical and chemical barrier against the virus.
"FabiSpray 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," the statement reads.
Terming the spray an effective and safe antiviral treatment for COVID-19, Glenmark Pharmaceuticals Ltd's Chief Commercial Officer Robert Crockart said "we are confident it will offer patients a much needed and timely therapy option."
"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," he said.
Over the issue of clinical trials results, Dr. Monika Tandon, Senior VP and Head of Clinical Development in Glenmark Pharmaceuticals Ltd. said,"The results from this Phase 3, double blind, placebo controlled trial are encouraging. Demonstration of reduction in the viral load has 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."
"As per studies conducted in the Utah State University USA, NONS is proven to kill 99.9 per cent of SARS-Cov-2 virus including Alpha, Beta, Gamma, Delta, and Epsilon variant within 2 minutes." She said.
Dr Srikanth Krishnamurthy one of the Principal Investigators of the study said, "I have had a chance to view the results of the study. Nitric Oxide Nasal Spray lowers the viral load and hastens RT-PCR negativity when used early in COVID 19 infection leading to recovery. Most importantly, viral load reduction with NONS has the potential to reduce the chain of transmission. Last but not the least, NONS being topical is safe and makes this therapeutic option very attractive".