JAKARTA - Glenmark Pharmaceuticals, a global pharmaceutical company that collaborates with SaNOtize Research & Development Corp. announced good results from the Phase 3 clinical trial of Nitric Oxide Nasal Spray (NONS) or known in Indonesia as Enovid Nose Sanitizer and in India named Fabispray.
The tests were carried out on adult COVID-19 patients, conducted at 20 locations in India. The study, conducted on COVID-19 patients, evaluated the efficacy and safety of NONS versus saline nasal spray in adult patients. The trial also analyzed patients at increased risk of symptoms—unvaccinated patients, patients in the middle and older age group, and patients with comorbidities.
Enovid Nose Sanitizer which produces "fresh nitric oxide" when sprayed into the nose, is designed to kill the COVID-19 virus in the upper respiratory tract. It has proven anti-microbial properties with direct virucidal effect on the SARS-CoV-2 virus. Nitric Oxide Nasal Spray (NONS) when sprayed over the nasal mucosa acts as a barrier and virus killer, preventing the incubation and spread of the virus to the lungs.
In the results of phase 3 clinical trials conducted on COVID-19 patients who are at increased risk of disease, unvaccinated patients, patients in the middle and older age group and patients with comorbidities. Results The average recovery time for COVID-19 for patients given Enovid was 4 days compared to 8 days in the placebo group (not given Enovid).
The use of Enovid is safe and well tolerated by patients. No patients experienced moderate, severe, serious adverse events or death in this study.
Dr. Monika Tandon, Senior Vice President & Head of Clinical Development, Glenmark Pharmaceuticals Ltd, said the results of the Phase 3 trial were very positive. The viral load reduction demonstration had a very helpful impact.
"In this scenario, with new variants emerging showing high transmissibility, Enovid provides a useful option in India's fight against COVID-19," said Monika, in a statement, quoted Friday 11 February.
"SaNOtize is pleased to announce these Phase 3 results which further strengthen the efficacy of our products as demonstrated by the Phase 2 trial in the UK, with our global partner, Glenmark," said Dr. Gilly Regev, Co-Founder and CEO of SaNOtize.
"We are very pleased to be able to provide COVID-19 patients with a product proven to provide faster healing. And with the proven strong safety profile of this phase 3 study, we hope it becomes the first choice of treatment, if not defense, for dealing with COVID-19 worldwide. the world," Gilly added.
In March 2021, clinical trials from SaNOtize demonstrated NONS is a safe and effective antiviral treatment for SARS CoV-2. In the first 24 hours, NONS reduced viral load by an average of about 95 percent, and then more than 99 percent in 72 hours.
In India's Phase 3 trial, viral load reductions of 94 percent at 24 hours and 99 percent at 48 hours were similar to the declines seen in the UK NHS trial conducted by SaNOtize.
NONS has been tested on healthy volunteers and patients as part of Canadian and UK clinical trials. SaNOtize has a global Phase 3 prevention trial underway, which will further add to its efficacy.
The Phase 3 clinical trial for NONS is now being completed by Glenmark. Glenmark has obtained marketing authorization for Nitric Oxide Nasal Spray (NONS) as a solution for handling COVID-19 in India. Glenmark also plans to submit clinical trial data for publication in a peer-reviewed journal to share its findings.
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