Lack of Strong Evidence: CDSCO panel rejects Glenmark proposal of using Nitric Oxide Nasal Spray for COVID-19 prevention

New Delhi: Citing lack of strong evidence on the use of Nitric Oxide Nasal Spray for prevention of COVID-19 infection, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the drug major Glenmark's proposal for the additional indication of Nitric Oxide Nasal Spray.

This came after the drug major Glenmark presented their proposal before the committee regarding the use of Nitric Oxide Nasal Spray for prevention of COVID-19 infection

Glenmark's Nitric Oxide Nasal Spray is available in the market under brand name Fabispray. This Nitric Oxide nasal spray, available in the form of a simple nasal spray, is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO), a natural nanomolecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus causing COVID-19.

Nitric oxide (NO) is released in the nasal airways in humans. During inspiration through the nose, this NO will follow the airstream to the lower airways and the lungs. Nasally derived NO has been shown to increase arterial oxygen tension and reduce pulmonary vascular resistance, thereby acting as an airborne messenger.
Earlier, the Medical Dialogues Team had reported that the Central Drugs Standard Control Organization (CDSCO) panel, had given its green signal to pharmaceutical major, Glenmark Pharmaceuticals, to conduct a phase 3 clinical trial of Nitric Oxide nasal spray for Covid-19 treatment with following conditions:

1. RTPCR negativity at 2,4 and 8 days should be one of the primary end points.

2. People vaccinated with the COVID-19 vaccine should be excluded from study.

3. At screening, only a chest X-ray should be done (Not the CT).

4. Dosing interval & schedule of administration of the product should be clearly mentioned in the protocol.

Also Read:COVID Treatment: Glenmark Gets CDSCO Panel Okay For Phase 3 Trial Of Nitric Oxide Nasal Spray

Now in continuation, at the recent SEC meeting for COVID-19 held on 20th January 2023, the expert panel reviewed the proposal presented by the drug major Glenmark for the additional indication of Nitric Oxide Nasal Spray.

After detailed deliberation, the committee opined that the firm did not present strong evidence on the use of applied drug products for the prevention of COVID-19 infection.