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Glenmark’s nitric oxide nasal spray (NONS), which it sells under the brand FabiSpray in India, reduces the viral load of Sars-CoV-2 in high-risk adult Covid-19 patients by 94 per cent within 24 hours and 99 per cent in 48 hours, according to the results of phase 3 trial of the drug published in The Lancet Regional Health Southeast Asia journal.
Glenmark had conducted the study on 306 vaccinated and unvaccinated adults with symptomatic mild Covid-19 disease across 20 clinical trial sites in India. The trial evaluated a seven-day treatment of NONS, plus the standard of care versus placebo nasal spray and standard of care in patients. NONS was administered six times daily as two sprays per nostril for seven days.
“Use of NONS in patients recently infected with SARS-CoV-2 accelerates nasal virus clearance,” the study published in The Lancet said. It said the high-risk population (unvaccinated or over 45 years of age, or with one or more comorbidities) demonstrated a ‘profound’ Sars-CoV-2 RNA burden reduction of 93.7 per cent at 24 hours and 99 per cent at 48 hours with NONS.
“NONS had a rapid effect of viral RNA reduction, i.e., a 7⋅4 fold greater viral RNA reduction compared to placebo at 48 hours of treatment,” the study showed.
Glenmark has tied up with Canadian biotech firm SaNOtize to manufacture, market, and distribute its NONS for Covid-19 treatment in India and other Asian markets. Glenn Saldanha, managing director and chief executive of Glenmark, had told Business Standard last year that a major clinical trial by SaNOtize was being conducted in Canada over 4,000 people to see if the drug also works in prevention of Covid-19.
It launched the nasal spray in India this February after the drug regulator gave nod to its launch after a local clinical trial.
NONS is designed to kill coronavirus in the upper airways, preventing it from incubating and spreading to the lungs. “It is based on nitric oxide, a natural nanomolecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus causing Covid-19,” a company spokesperson has said.
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