SEC refuses to recommend Glenmark nasal spray for Covid-19 additional indication

New Delhi, February 16, 2023 :

The Subject Expert Committee (SEC), which advises the central drug regulator on approval of drugs and clinical trials, has refused to recommend Glenmark Pharmaceuticals’ Nitric Oxide Nasal Spray (NONS) for the additional indication of prevention of Covid-19 infection, citing lack of strong evidence.

Glenmark, in collaboration with Canadian pharmaceutical company SaNOtize Research & Development Corp announced the launch of NONS spray under the brand name FabiSpray in India for the treatment of adult patients with Covid-19 who have high risk of progression of the disease, on February 9, 2022.

Later, the company presented its proposal of additional indication of the nasal spray and supported it with additional clinical and in-vitro data and the SEC, to examine Covid-19 related product proposal under accelerated approval process, has been looking at the proposal from its meeting in May, 2022.

In a meeting held in October, 2022, the SEC opined that the firm should submit available published literature in public domain and the power point presentation made by the firm to the Central Drugs Standard Control Organisation (CDSCO) for further evaluation by experts.

The Committee, in its meetings, also noted that the product has been approved for treatment of adult high risk patients with mild Covid-19 having risk of progression of the disease.

In a meeting of the Committee held in November, 2022, the Committee opined that the firm did not present any published literature on the effect of the NONS in Covid-19 prophylaxis before the Committee. It also added that the company should comply with the recommendation to submit available published literature in public domain and the power point presentation for further evaluation by the experts.

However, in the latest meeting of the SEC related to approval of Covid-19 products, in January, 2023, the committee opined that the firm did not present strong evidence on the use of the applied drug product for prevention of Covid-19 infection.

“In view of the above, the committee did not recommend for approval of the proposal of additional indication of Nitric Oxide Nasal Spray due to lack of strong evidence for proposed indication,” said the Committee.

FabiSpray is designed to kill the Covid-19 virus in the upper airways and it has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2. NONS when sprayed over nasal mucosa acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs, said the company while launching the product in 2022.

In its previous annual report, the company said that the agreement with the Canadian biotech firm is to bring the product to India and to 13 other Asian countries. In July, the company released a study published in the peer reviewed journal of The Lancet Regional Health Southeast Asia (TLRHSEA) demonstrated that the patients who received NONS had significant reduction in viral load within 24 hours, which was sustained over seven days of treatment. Viral load was reduced by 93.7 per cent within 24 hours and by 99 percent within 48 hours of treatment with NONS.

It was in July 2021, Glenmark entered into an exclusive long term strategic partnership with SaNOtize, 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. The drug is sold under the name Envoid or VirX in some of the other countries. Pharmabiz