The Indian tool-kit to treat Covid now has a Nitric Oxide nasal spray (NONS) in it from Glenmark Pharmaceuticals and Canadian pharmaceutical company SaNOtize Research & Development Corp.

Approved for the treatment of adult patients with Covid, who have a high risk of disease progression, the spray will be available at chemists from this week, Dr Monika Tandon, Glenmark Pharma’s Senior - and Head (Clinical Development), told BusinessLine. Marketed under the FabiSpray brandname in India, the spray will be available on doctor’s prescription. Priced at ₹850 for a 25 ml bottle, it covers the length of one person’s treatment, Tandon explained.

The spray has established safety and is given in six doses through the day, she said, adding that they were evaluating its use in children over 12 years. At present it is given to adults with mild Covid-19, in the first 3-5 days, a treatment timeline similar to more expensive antivirals such as molnupiravir and favipiravir, she observed.

DCGI approval

Glenmark had received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS under the accelerated approval process. The spray is designed to kill SARS-CoV-2 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 Glenmark.

Significantly, the spray is not “variant-specific”, and has been seen to work against the alpha, beta and delta variants of SARS-CoV-2, besides the Rhinovirus and H1N1 virus as well, said Tandon.

Glenmark has an exclusive long-term partnership with SaNOtize, inked last July, to manufacture, market and distribute the product in India and other Asian markets, including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.

India Phase 3 clinical trial

The advanced Phase 3 clinical trial was conducted in adult Covid 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 trial analysed patients with risk of progression of disease - non-vaccinated patients, patients in the middle and older age group and patients with co-morbidities. The primary endpoint was met, the company said, adding the reduction in log viral load in the NONS group was statistically significant and superior to the control (placebo) group.

Global trial, approvals

In March 2021, clinical trials from the innovator SaNOtize showed NONS was a safe and effective antiviral treatment of SARS CoV-2. In the first 24 hours, NONS reduced the average viral load by around 95 percent and then by more than 99 percent within 72 hours.

Globally, it has received the regulatory CE mark in Europe. By virtue of the CE mark, SaNOtize has permission to launch in the EU. The product is also approved and being sold in Israel, Thailand, Indonesia and Bahrain.