India launches nasal spray to treat adult COVID-19 patients
New Delhi: Mumbai-based pharmaceutical company Glenmark has launched nitric oxide nasal spray under the brand name FabiSpray for the treatment of adult patients infected with COVID-19. The nasal spray was launched in partnership with Canadian pharmaceutical company SaNOtize.
The Mumbai-based pharmaceutical company had previously received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for Nitric Oxide Nasal Spray (NONS) under the fast-track approval process. The nasal spray was designed to kill the coronavirus in the upper respiratory tract.
“FabiSpray, Nitric Oxide Nasal Spray, is designed to kill the COVID-19 virus in the upper respiratory tract. It has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2. NO, when sprayed on the nasal mucosa, acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs,” the drugmaker said in a statement.
“A phase 3 clinical trial was conducted in adult patients with COVID-19 at 20 clinical sites in India. The multicenter, double-blind, parallel-arm study of 306 patients evaluated the efficacy and safety of nitric oxide nasal spray compared to normal saline nasal spray in non-hospitalized adult patients. All patients received standard supportive care in the study,” the statement continued.
Dr Srikanth Krishnamurthy, one of the study’s lead researchers, said the nitric oxide nasal spray lowers viral load and accelerates RT-PCR negativity when used early in infection to COVID 19 leading to recovery. More importantly, viral load reduction with NONS has the potential to reduce the chain of transmission. Last but not least, NONS being topical, is safe and makes this treatment option very attractive, he added.
NONS has already received CE marking in Europe, which is equivalent to marketing authorization in the case of a medical device, the pharmaceutical company said.
Calling the spray an effective and safe antiviral treatment for COVID-19, Glenmark Pharmaceuticals Ltd Chief Commercial Officer Robert Crockart said: “We are confident that it will provide patients with a much needed and timely treatment option.
“As a leading pharmaceutical player, it is important that we are an integral part of India’s fight against the COVID-19 pandemic. We are pleased to receive regulatory approval for nitric oxide nasal spray (FabiSpray) and launch it in partnership with SaNOtize,” he said.
On the issue of clinical trial results, Dr. Monika Tandon, Senior Vice President and Head of Clinical Development at Glenmark Pharmaceuticals Ltd., said: “The results of this Phase 3, double-blind, placebo-controlled trial are encouraging. Demonstration of viral load reduction has a significant positive impact from a patient and community perspective. In the current scenario, with new variants emerging with high transmissibility, NONS offers a useful option in India’s fight against COVID-19.
“According to studies conducted at Utah State University in the United States, NONS has been proven to kill 99.9% of the SARS-Cov-2 virus, including Alpha, Beta, Gamma, Delta and Epsilon in 2 minutes.” She said.
Dr Srikanth Krishnamurthy, one of the study’s principal investigators, said: “I was lucky enough to see the results of the study. Nitric oxide nasal spray reduces viral load and accelerates RT-PCR negativity when used early in COVID 19 infection, leading to cure. More importantly, viral load reduction with NONS has the potential to reduce the chain of transmission. Last but not least, NONS being topical is safe and makes this treatment option very attractive.”