Glenmark Pharmaceuticals Limited (Glenmark) and Canadian pharmaceutical company SaNOtize Research & Development Corp. today 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 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.
“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 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,”Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd. said.
What is 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.
Indian Phase 3 Clinical Trial Outcomes
A Phase 3 clinical trial was conducted in adult COVID-19 patients across 20 clinical sites in India. The double-blind, parallel-arm, multicenter study, conducted in 306 patients evaluated the efficacy and safety of Nitric.
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 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.”
Dr. Srikanth Krishnamurthy one of the Principal Investigators of the study commented, “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”.
Catch all the Business News, Market News, Breaking News Events and Latest News Updates on Live Mint. Download The Mint News App to get Daily Market Updates.
MoreLess