Glenmark Pharmaceuticals Limited (Glenmark) – a global, innovation-driven pharmaceutical companyand 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.
Commenting on the significance of this development, Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd. 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.”
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 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”.