New Delhi: In its fight against the deadly virus, Glenmark Pharmaceuticals Limited (Glenmark) and Canadian pharmaceutical company SaNOtize Research & Development Corp on Wednesday announced the launch of its Nitric Oxide Nasal Spray under the brand name FabiSpray in India to treat adult patients with Covid-19 who faces the high risk of progression of the disease.
It received manufacturing-marketing approval from India’s drug regulator for Nitric Oxide Nasal Spray as part of the accelerated approval process, according to the news agency ANI.
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Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd expressed his happiness over receiving regulatory approval for Nitric Oxide Nasal Spray (FabiSpray®) and launching 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," the report quoted Crockart.
How does FabiSpray work?
Nitric Oxide Nasal Spray (NONS) launched under the brand name FabiSpray has been designed to kill the Covid-19 virus in the upper airways. The spray has proven to contain anti-microbial properties with a direct virucidal effect on SARS-CoV-2. Upon spraying NONS over nasal mucosa, it acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs.
What was the outcome of the Phase 3 Clinical Trial?
Under the Phase 3 clinical trial, adult Covid-19 patients had undergone trials across 20 clinical sites in India. The double-blind, parallel-arm, multicenter study, conducted in 306 patients evaluated the efficacy and safety of Nitric.
Dr. Monika Tandon, Senior VP & Head - Clinical Development, Glenmark Pharmaceuticals Ltd had informed that the trial was encouraging. “The 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,” Mint quoted Tandon in the report. She said NONS is a useful option in the current scenario in India’s fight against Covid-19 as new emerging variants are exhibiting high transmissibility.
Dr. Srikanth Krishnamurthy one of the Principal Investigators of the study told the publication, “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, Krishnamurthy added.