Glenmark Pharmaceuticals Limited (Glenmark) and SaNOtize Research & Development Corp., a Canadian pharmaceutical company, today announced the launch of FabiSpray, a Nitric Oxide Nasal Spray for the treatment of adult patients with COVID-19 who are at high risk of disease progression.
As part of the accelerated approval process, Glenmark received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS.
FabiSpray, Nitric Oxide Nasal Spray, is designed to kill the COVID-19 virus in the upper airways. It has been shown to have antimicrobial properties as well as a direct virucidal effect on SARS-CoV-2. NONS acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs when sprayed over the nasal mucosa.
â€œAs a leading pharmaceutical player, it is important that we are an integral part of Indiaâ€™s fight against the COVID-19 pandemic. We are happy to receive regulatory approval for Nitric Oxide Nasal Spray (FabiSprayÂ®) 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.
Adult COVID-19 patients were enrolled in a Phase 3 clinical trial across 20 clinical sites in India. The efficacy and safety of Nitric were assessed in a double-blind, parallel-arm, multicenter study involving 306 patients.
Dr. Monika Tandon, Senior VP & Head – Clinical Development, Glenmark Pharmaceuticals Ltd., commented, â€œThe 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 Indiaâ€™s fight against COVID-19.”
â€œI 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”, Dr. Srikanth Krishnamurthy one of the Principal Investigators of the study commented.