FabiSpray: The first nasal spray named 'Nitric Oxide Nasal Spray" (FabiSpray) was launched by Mumbai-based Glenmark Pharmaceuticals Limited in partnership with Canadian pharmaceutical company SaNOtize Research & Development Corp. It will help in the treatment of adult COVID-19 patients who have a high risk of progression of the disease.
The Drugs Controller General of India (DCGI) gave manufacturing and marketing approval to Glenmark as a part of the accelerated approval process.
Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd. said "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 happy to receive regulatory approval for Nitric Oxide Nasal Spray (FabiSpray) and launch it in partnership with SaNOtize. This reaffirms our commitment to providing yet another safe and effective antiviral treatment for COVID-19, and we are confident it will offer patients a much needed and timely therapy option".
As per the two companies, a nasal spray is 'effective and 'safe' antiviral treatment for adults COVID-19 patients and also expressed hope that it will "offer patients a much needed and timely therapy option".
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About Nitric Oxide Nasal Spray (FabiSpray)
It is designed to kill the COVID-19 virus in the upper airways.
It consists of proven antimicrobial properties with a direct virucidal effect on SARS-CoV-2.
When NONS (FabiSpray) is sprayed over nasal mucosa it acts as a physical and chemical barrier against the virus and prevents it from incubating and spreading to the lungs.
As per the company official statement "the marketed price of FabiSpray is Rs 850 per unit. The recommended dose for mild COVID-19 adults treatment is two sprays in each nostril, six times a day for seven days. Also, the spray can be used when only a registered medical practitioner prescribes it."
Dr. Monika Tandon, head of clinical development at Glenmark said that "The pricing of FabiSpray is nominal in India compared to other countries."
Tandon also stated that the nasal spray is based on nitric oxide, which has proven anti-microbial properties and a direct effect on SARS-VoV-2."
What are the outcomes of Phase 3 Clinical Trial in India?
Glenmark in a statement said that its Phase 3 clinical trial was conducted in adult COVID-19 patients across 20 clinical sites in India.
The double-blind, parallel-arm, multicenter study, conducted in 306 patients evaluated the efficacy and safety of Nitric with that of saline nasal spray in non-hospitalised adult patients. All the patients were provided standard supportive care in the study.
The trial was conducted on patients with risk of progression of disease that is non-vaccinated, patients in the middle and older age group, and patients with comorbidities.
According to Dr. Monika Tandon, "The results from this Phase 3, double-blind, placebo-controlled trial are encouraging. Demonstration of reduction in the viral load has a significant positive impact from a patient and community perspective. In the current scenario, with new emerging variants exhibiting high transmissibility, NONS provides a useful option in India’s fight against COVID-19."
It has also been stated by one of the Principal Investigators in the study that the FabiSpray lowers the viral load and hastens RT-PCR negativity when used early in COVID-19 infection leading to recovery. Also, important is that the viral load reduction with NONS has the potential to reduce the chain of transmission. NONS is also safe and makes this therapeutic option very attractive.
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