INDIA – Glenmark Pharmaceuticals Limited has received manufacturing and marketing approval for Nitric Oxide Nasal Spray (NONS) from India’s drug regulator as part of an accelerated approval process for the treatment of adult patients with COVID-19 who are at high risk of disease progression.

As part of the accelerated approval process, Glenmark previously received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS.

Nitric Oxide Nasal Spray named FabiSpray, has been launched in partnership with Canadian pharmaceutical company SaNOtize Research & Development Corp.

FabiSpray is designed to kill the Covid-19 virus in the upper airways. As per the company’s claims, the Nitric Oxide Nasal is sprayed over nasal mucosa which then acts as a physical and chemical barrier against the virus. It will prevent the virus from incubating and spreading to the lungs, the statement reads.

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.

Glenmark signed a long-term exclusive partnership with SaNOtize in July 2021 to manufacture, market, and distribute the product in India and other Asian markets such as Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste, and Vietnam.

India Phase III clinical trial

The advanced Phase III clinical trial in adult Covid patients was conducted across 20 clinical sites in India.

The study compared the efficacy and safety of Nitric Oxide Nasal Spray versus normal saline nasal spray in non-hospitalized adult patients in a double blind, parallel arm, multicenter study involving 306 patients. In the study, all patients received standard supportive care.

The trial looked at patients who were at risk of disease progression – non-vaccinated patients, patients in their middle and older years, and patients with co-morbidities.

According to the company, the primary endpoint was met, and the reduction in log viral load in the NONS group was statistically significant and superior to the control (placebo) group.

Global trial and approvals

Clinical trials conducted by the innovator SaNOtize in March 2021 revealed that NONS was a safe and effective antiviral treatment for SARS CoV-2.

NONS reduced the average viral load by around 95 percent in the first 24 hours and then by more than 99 percent within 72 hours.

Globally, it has been given the regulatory CE mark in Europe. SaNOtize is permitted to launch in the EU due to the CE mark. Israel, Thailand, Indonesia, and Bahrain have also approved and are selling the product.

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