The Mumbai-based drug firm had earlier received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for the Nitric Oxide nasal spray (NONS) as part of the accelerated approval process. The nasal spray has been designed to kill the coronavirus in the upper airways.

 

"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", said the drug manufacturer in a statement.

 

"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 statement reads further.

 

Dr Srikanth Krishnamurthy one of the Principal Investigators of the study said that 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, he added.

 

NONS has already received a CE mark in Europe, which is an equivalent of marketing authorization in case of a Medical Device, claimed the drug company.