Highlights:
- Glenmark could launch nasal spray to treat COVID-19 in India in 2021
- Glenmark has already entered into a contract with Canadian biotech SaNOtize to sell its Nitric Oxide Nasal Spray for COVID-19
- Glenmark will sell the nasal speak in Asian markets including India
On Monday, the Mumbai based Glenmar Pharmaceuticals Limited announced that it has entered an exclusive long-term strategic partnership with the Canadian biotech firm SaNOtize Research to manufacture, market as well as distribute its breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in India along with other Asian markets.
Glenmark is expecting the launch of the nasal spray within 2021 under the brand name “FabiSpray” in India. In a filing the Mumbai based pharma company said, “The Phase III clinical trial for NONS is expected to be completed, followed by commercial launch under the brand name FabiSpray in India, by fourth quarter of the calendar year 2021”.
Earlier in 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 Canadian nasal spray.
The committee has recommended a Phase III clinical trial be conducted on Indian patients.
In March this year, the clinical trials conducted by SaNOtize showed NONS was not only safe but also an effective antiviral treatment to prevent the transmission of COVID‐19, shorten its course, as well as reduce the severity of symptoms.
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In the initial 24 hours, NONS reduced the average viral load by close to 95%, and then by more than 99% within 72 hours.
The company added that It has been tested in healthy volunteers and patients as part of UK and Canada clinical trials.
Available in the form of a simple nasal spray, it is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. The nasal spray is based on nitric oxide (NO) – a natural nano‐molecule with proven anti‐microbial properties – and which has a direct effect on SARS‐CoV‐2, the virus causing COVID‐19.
The statement said, “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).”
