On Monday, Glenmark Pharmaceuticals announced an exclusive long-term strategic relationship with SaNOtize Research, a Canadian biotech startup, to produce, market, and distribute their revolutionary Nitric Oxide Nasal Spray (NONS) for Covid19 therapy in India and other Asian regions.
It plans to launch the nasal spray in India this year under the moniker FabiSpray. ”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,” Glenmark said in a filing.
In early July 2021, Glenmark presented a proposal to the Subject Expert Committee of CDSCO for emergency approval for import and marketing of the nasal spray. The committee has recommended a Phase III clinical trial to be conducted in Indian patients.
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.
”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 said.
