New Delhi: In a first, a novel nitric oxide nasal spray was launched in India Wednesday for treating Covid-19 among adults who are at high risk of progressing to severe stages of the viral disease.
The spray is designed to kill the coronavirus (SARS-CoV-2) in the upper airways.
Manufactured by Glenmark Pharmaceuticals Limited, in collaboration with Canadian pharmaceutical company SaNOtize Research & Development Corp, the spray will be marketed under the brand name ‘FabiSpray’ in India. Glenmark had earlier received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) as part of the accelerated approval process.
The retail price of a 25 ml unit of the spray will be Rs 850. A prescription from a registered medical practitioner will be required for its purchase.
Approval for the spray came after phase three of clinical trials, conducted among 306 adult Covid-19 patients across 20 clinical sites in India showed that it was safe for use in non-hospitalised adult patients. The trials were conducted between August 2021 and January 2022.
“The results from this phase 3, double blind, placebo controlled trial are encouraging. Demonstration of reduction in the viral load has significant positive impact from a patient and community perspective. In the current scenario, with new emerging variants exhibiting high transmissibility, Nitric oxide nasal spray provides a useful option in India’s fight against Covid-19,” Monika Tandon, senior VP and head, Clinical Development, Glenmark Pharmaceuticals Ltd, said in a statement.
Also Read: At 0.68, India’s Covid R value lowest since pandemic began, below 1 for first time since Dec
What the study found
The clinical study conducted in India analysed patients with risk of progression of Covid-19. These included patients who were not vaccinated, in the middle and older age groups, or had comorbidities. Along with the nasal spray, all patients received standard supportive care for Covid-19 during the course of the study.
The study showed that the viral load in those who received the spray reduced faster compared to those who did not. The researchers noted a 94 per cent reduction of viral load in 24 hours, and 99 per cent in 48 hours.
Moreover, Covid patients who were administered the spray saw the virus clearing in an average of four days, as opposed to eight days in those who were not.
Patients who used the spray were less likely to progress to severe Covid than those who did not, the study found.
“Nitric oxide nasal spray (NONS) 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,” Srikanth Krishnamurthy, one of the principal investigators of the study, said in a statement.
In its statement, Glenmark mentioned that previous studies conducted at Utah State University in the US had shown that the spray can kill 99.9 per cent of SARS-Cov-2’s Alpha, Beta, Gamma, Delta, and Epsilon variants within two minutes.
Nitric oxide acts as a physical and chemical barrier against the virus in the mucous lining of the nasal cavity, preventing it from incubating and spreading to the lungs, according to Glenmark’s statement. According to an earlier study by Swedish researchers published in the US National Library of Medicine, the colourless, odourless gas was found to be able to stop replication of the Severe Acute Respiratory Syndrome (SARS) virus, which is associated with the coronavirus.
According to an article in The Harvard Gazette, Harvard University’s official press organ, nitric oxide can widen blood vessels and is also used as treatment in low oxygen environments like high altitude regions.
Global trial ongoing for more data on efficacy
In July last year, Glenmark had entered into an exclusive long-term strategic partnership with Canadian biotech firm SaNOtize to manufacture, market and distribute the spray for Covid-19 treatment in India and other countries including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.
SaNOtize is currently continuing to conduct a global phase 3 prevention trial, which will further add to data available on the efficacy.
(Edited by Gitanjali Das)
Also Read: ‘Mishandling Covid eroded support for populist govts like Modi’s’: Cambridge democracy study