Glenmark Pharma expects to launch its anti-COVID-19 nasal spray in India this year

Indian pharmaceutical company Glenmark Limited has signed an agreement with Canadian biotech firm SaNOtize Research and Development Corp to commercialize its nasal spray for COVID-19 treatment in India and other Asian countries. 

As part of the exclusive long term strategic partnership, Glenmark and SaNOtize will manufacture, market, and distribute its Nitric Oxide Nasal Spray (NONS) in India, Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor Leste, and Vietnam, according to a statement by the company.

Glenmark expects to launch the nasal spray this year under the brand name 'FabiSpray' in India. ''The Phase III clinical trial for NONS is expected to be completed, followed by commercial launch under the brand name FabiSpray in India, by the fourth quarter of the calendar year 2021,'' the company said in a filing.

It is available in the form of a simple nasal spray, and it is designed to kill the coronavirus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO) and has a direct effect on the COVID-19 virus.

In March 2021, SaNOtize’s clinical trials showed NONS was a safe and effective antiviral treatment to prevent the transmission of COVID‐19, shorten its course, and reduce the severity of symptoms. In the first 24 hours, NONS reduced the average viral load by around 95%, and then by more than 99% within 72 hours. It has been tested in healthy volunteers and patients as part of UK and Canada clinical trials, the company added. 

CDSCO recommends phase III trials in India

In early July 2021, Glenmark presented a proposal to the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) for emergency approval for the import and marketing of the nasal spray. The committee recommends conducting a Phase III clinical trial in Indian patients. 

''NONS is one of the few novel therapeutic treatments, outside of expensive monoclonal antibodies, that is proven to reduce SARS‐CoV‐2 viral load in humans.2 NONS has already received a CE mark in Europe, which is an equivalent of marketing authorization in case of a Medical Device (CE mark confirms that the medical device meets certain “essential requirements" of the European General Medical Devices Directive and is safe for the intended purpose),'' the statement added.

Image Credit: PTI/Representative