Glenmark Pharmaceuticals has launched a nasal spray in India to treat adult patients suffering from Covid-19. Nitric Oxide Nasal Spray named FabiSpray, has been launched in partnership with Canadian biotech firm SaNOtize Research. 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.
FabiSpray, India’s first nasal spray to treat COVID
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 Oxide Nasal Spray versus normal saline nasal spray in non-hospitalized adult patients. All patients received standard supportive care in the study.
-The trial analyzed patients with risk of progression of the disease – non-vaccinated patients, patients in the middle and older age group and patients with co-morbidities.
“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.” Dr Monika Tandon, Senior VP and Head of Clinical Development in Glenmark Pharmaceuticals Ltd. 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”.
In July 2021, Glenmark had entered into an exclusive long term strategic partnership with Canadian biotech firm SaNOtize to manufacture, market and distribute its Nitric Oxide Nasal Spray for COVID-19 treatment in India and other Asian markets.