Nitric Oxide spray proven to kill 99.9% of COVID-19 within 2 mins: Glenmark SPV

As the COVID-19 pandemic is receding in India, Indian pharmaceutical industry has so far launched several medical products to tackle the highly infectious disease. The latest is a nasal spray from Glenmark Pharmaceuticals for treatment of the virus, the Mumbai-based pharmaceutical company.

Dr Monika Tandon, Senior Vice President and Head, Clinical Development, Glenmark Pharmaceuticals spoke to Business Today about India’s first Nitric Oxide Nasal Spray (NONS) named FabiSpray launched by the company and all aspects about the product ranging from its efficacy and usage. Edited excerpts from an interview.

What is FabiSpray and how effective it is?  

FabiSpray has been launched in collaboration with Canadian pharmaceutical company SaNOtize Research and Development Corporation. FabiSpray is used for treating adult COVID-19 patients who are at high risk of progression of the disease—non-vaccinated patients, patients in the middle and older age group, and patients with co-morbidities. It is a Nitric Oxide Nasal Spray (NONS) and is designed to kill the COVID-19 virus in the upper airways. It has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2. The product when sprayed over nasal mucosa acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs.

Can you share data related to clinical trials in India?

Glenmark recently concluded a double-blind, parallel arm, multicenter phase 3 study, in 306 Indian patients.  The study evaluated the efficacy and safety of NONS, versus normal saline nasal spray in non-hospitalized adult patients, randomized within a 72-hour window of symptom onset.  The phase 3 trial conducted by Glenmark involved patients who suffered possibly by either Delta or Omicron variants between August 2021 and January 2022. The primary and secondary outcome measures demonstrated the efficacy and safety of the NONS treatment arm over the control arm that was administered normal saline nasal spray as placebo in double-blind manner. The trial also included patients with a risk of disease progression like non-vaccinated patients, patients in the middle and older age group, and patients with co-morbidities. The primary endpoint was achieved. NONS was safe and well tolerated by all patients, who were part of the clinical trial. There were no reports of moderate or severe or serious Adverse Events (AE) or death in the study.  An independent Data and Safety Monitoring Board (DSMB) concluded that NONS was safe in COVID-19 patients.  

Can you share some insights on the efficacy of the NONs based nasal spray?

Nitric oxide nasal spray (NONS) has good data available for demonstrating its safety and broad-spectrum antiviral effect and efficacy in COVID-19 patients and healthy subjects in 3 clinical studies.

As per the laboratory study, NONS has proven to kill 99.9% of SARS-Cov-2 virus including its Delta variant within 2 minutes.  Clinical trials have shown that NONS is a safe and effective antiviral treatment to prevent the transmission of COVID-19, shorten its course, and reduce the severity of symptoms. As mentioned earlier, the Phase 3, double-blind, placebo-controlled trial that we conducted in India demonstrated a median time to virological cure of 4 days in the NONS group and 8 days in the placebo group (p

Is the nasal spray a prescribed drug and what will be the dosage for treatment? When and where will the product be available in the market? Also, what does it cost to use the product?

Since FabiSpray has been approved in India for the treatment of COVID-19, its administration is based on prescription by and discretion of a registered medical practitioner.  The recommended dosage of FabiSpray for treatment of mild COVID-19 in adults is two sprays in each nostril, six times a day for 7 days. FabiSpray is already available in the country and is priced at Rs 850 which is the entire cost of the treatment for a patient. The pricing of FabiSpray is nominal in India compared to other countries. Glenmark is educating healthcare practitioners from across the country in this regard by organizing seminars and education sessions across the clinics. The company aims to create awareness about FabiSpray among more than 100,000 healthcare practitioners across the country.

Since the recent trend shows that the pandemic is on the decline, what will be the future of Fabispray? Is it effective for any other forms of viral infections?

Though the recent trend shows decline in the pandemic, one cannot just write it off looking at the earlier waves and with new emerging variants which are highly transmissible. In the study by Utah University, USA, a direct virucidal effect of NONS was seen against SARS-CoV-2 strains Alpha (B.1.1.7) , Beta (B.1.351), Gamma (P.1) Epsilon ( b.1.427) and DeltaB.1.617.2) variants suggesting NONS’ antiviral effect is not variant specific.  With a topical administration and a strong safety profile, we see a lot of potential for NONS (FabiSpray), which is a safe and highly efficacious treatment against the SARS-CoV-2 virus. In addition to its anti-SARS CoV-2 activity, Nitric Oxide Nasal Spray also acts against other respiratory viruses including SARS-Cov-1, H1N1, Human Rhinovirus (HRV)-14, and Respiratory Syncytial Virus (RSV).