Glenmark Pharma on Wednesday announced the launch of its nitric oxide nasal spray (NONS) for the treatment of Covid in adult patients considered to be at high risk of disease progression.
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, the company claims.
The company had received manufacturing and marketing approval from the Drugs Controller General of India for “FabiSpray” as part of an accelerated approval process. The product has been launched by Glenmark in partnership with a Canadian pharmaceutical firm, SaNOtize Research & Development, a company statement said.
FabiSpray will be marketed at a price of Rs 850 per unit. The recommended dosage for treatment of mild Covid-19 in adults is two sprays in each nostril, six times a day for seven days. The spray should be used only if a registered medical practitioner prescribes it, a company official said.
Last year, Cipla Health had launched Naselin Anti-Viral Nasal Spray with Povidone Iodine to protect against the novel coronavirus and other respiratory tract infections. There is no robust evidence yet on the efficacy of such nasal sprays.
A Phase 3 clinical trial was conducted in adult Covid patients across 20 clinical sites in India, Glenmark said. The doubleblind, parallel arm, multi-centre study, conducted in 306 patients, evaluated the efficacy and safety of NONS versus normal saline nasal spray in non-hospitalised 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.