Published 20:56 IST, August 2nd 2021
Glenmark Pharma expects to launch its anti-COVID-19 nasal spray in India this year
Glenmark Limited has signed an agreement with SaNOtize Research and Development Corp to commercialize 'FabiSpray', its nasal spray for COVID-19 treatment.
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Indian pharmaceutical company Glenmark Limited has signed an agreement with Canian biotech firm Satize Research and Development Corp to commercialize its nasal spray for COVID-19 treatment in India and or Asian countries.
As part of exclusive long term strategic partnership, Glenmark and Satize will manufacture, market, and distribute its Nitric Oxide Nasal Spray (NS) in India, Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor Leste, and Vietnam, according to a statement by company.
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Glenmark expects to launch nasal spray this year under brand name 'FabiSpray' in India. '' Phase III clinical trial for NS is expected to be completed, followed by commercial launch under brand name FabiSpray in India, by fourth quarter of calendar year 2021,'' company said in a filing.
It is available in form of a simple nasal spray, and it is designed to kill coronavirus in upper airways, preventing it from incubating and spreing to lungs. It is based on nitric oxide () and has a direct effect on COVID-19 virus.
In March 2021, Satize’s clinical trials showed NS was a safe and effective antiviral treatment to prevent transmission of COVID‐19, shorten its course, and reduce severity of symptoms. In first 24 hours, NS reduced aver viral lo by around 95%, and n by more than 99% within 72 hours. It has been tested in healthy volunteers and patients as part of UK and Cana clinical trials, company ded.
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CDSCO recommends phase III trials in India
In early July 2021, Glenmark presented a proposal to subject expert committee of Central Drugs Standard Control Organisation (CDSCO) for emergency approval for import and marketing of nasal spray. committee recommends conducting a Phase III clinical trial in Indian patients.
''NS is one of few vel rapeutic treatments, outside of expensive moclonal antibodies, that is proven to reduce SARS‐CoV‐2 viral lo in humans.2 NS has alrey received a CE mark in Europe, which is an equivalent of marketing authorization in case of a Medical Device (CE mark confirms that medical device meets certain “essential requirements" of European General Medical Devices Directive and is safe for intended purpose),'' statement ded.
Im Credit: PTI/Representative
20:56 IST, August 2nd 2021