9 Feb 2022 , 10:43 AM
In its press release on Wednesday, Glenmark Pharmaceuticals Ltd., a global, innovation-driven pharmaceutical company, announced the launch of its Nitric Oxide Nasal Spray under the brand name FabiSpray in India, in association with Canadian pharmaceutical company SaNOtize Research & Development Corp. The drug will be available for the treatment of patients with COVID-19 who have a high risk of progression of the disease.
Earlier, Glenmark received approval for marketing and manufacturing from the Drugs Controller General of India (DCGI) for NONS as part of its accelerated approval process.
FabiSpray is Nitric Oxide Nasal Spray explicitly designed to kill the COVID-19 virus in the upper airways. It has proven anti-microbial properties have a direct virucidal effect on SARS-CoV-2. NONS when sprayed over nasal mucosa prevents the virus from incubating and spreading to the lungs, acting as a physical and chemical barrier against the virus.
“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 glad to receive regulatory approval for Nitric Oxide Nasal Spray (FabiSpray) and launch it in partnership with SaNOtize. This reaffirms our commitment & dedication 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,” commented Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd.
The company conducted Phase 3 clinical trial 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. In its conclusion, there was a reduction in log viral load in the NONS group that was statistically significant and superior to the control (placebo) group (p < 0.05).
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