Glenmark Pharmaceuticals Limited and SaNOtize Research & Development Corp. 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.

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 disease - non-vaccinated patients, patients in the middle and older age group and patients with co-morbidities.

Primary endpoint was met: Reduction in log viral load in the NONS group was statistically significant and superior to the control (placebo) group (p < 0.05). The median time to virological cure was 4 days in the NONS group and 8 days in the placebo group (p < 0.05). A significantly higher proportion of patients demonstrated a 2-point improvement on the WHO Progression Scale (a validated clinical endpoint) in the NONS group as compared to the placebo group (p < 0.05).

NONS was safe and well tolerated by patients. No patients experienced moderate, severe, serious Adverse Events (AE) or death in the study.