COVID treatment: Glenmark gets CDSCO panel okay for phase 3 trial of Nitric Oxide nasal spray

New Delhi: In a significant development, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO), has 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.

The approval, however, is subject to several conditions.

This came after Glenmark provided the committee with its Phase –III clinical trial protocol in compliance with the earlier recommendation.

Medical Dialogue team had earlier reported that Glenmark had entered into an exclusive long term agreement with Canadian biotech firm SaNOtize Reasearch and Development Corp. to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray for COVID-19 treatment in India and other Asian markets, including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste, and Vietnam.

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.

Furthermore, clinical testing conducted by SaNOtize in March 2021 revealed that Nitric Oxide nasal spray was a safe and effective antiviral medication for preventing COVID-19 transmission, shortening its course, and reducing the severity of symptoms. Nitric oxide nasal spray lowered the average viral load by roughly 95% in the first 24 hours, and by more than 99 percent in the next 72 hours. In clinical studies in the United Kingdom and Canada, it was evaluated on healthy volunteers and patients.

Glenmark Pharmaceutical presented their proposal for issuance of emergency approval for import and marketing of the drug product to the committee in early July 2021, based on the results of a clinical trial completed by SaNOtize. In response, the committee suggested that the firm should perform a Phase III clinical trial in Indian patients and asked the firm to submit a trial protocol for evaluation by the committee at its 166th SEC meeting for examining COVID-19 related proposal under the accelerated approval process.

Moving forward, Glenmark Pharmaceutical presented its Phase –III clinical trial protocol to the committee in light of the prior suggestion, which was thoroughly assessed by the committee during its 166th SEC meeting for the COVID-19-related proposal.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase-III clinical trial subject to the 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.

5. Withdrawal criteria should be specified in the protocol clearly.