Glenmark Pharmaceuticals and SaNOtize have announced the approval of FabiSpray nitric oxide nasal spray (NONS) for the treatment of COVID-19 by the Drugs Controller General of India (DCGI) and the launch of the nasal spray in that country. Glenmark announced in August 2021 that it had acquired the rights to the NO nasal spray for the treatment of COVID-19 in India and a number of other Asian markets.
In March 2021, SaNOtize said that a Phase 2 trial of NONS in COVID-19 patients demonstrated that the nasal spray reduced viral load by about 95% within 24 hours and 99% in 72 hours. According to Glenmark, a Phase 3 clinical trial that enrolled 306 Indian COVID-19 patients met its primary endpoint of statistically significant reduction in log viral load in patients who received NONS compared to patients who received a saline nasal spray, with a 94% reduction of viral load within 24 hours and 99% reduction in 48 hours.
Glenmark Senior VP and Head of Clinical Development Monika Tandon said, “The results from this Phase 3, double blind, placebo controlled trial are encouraging. Demonstration of reduction in the viral load has 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.”
Chief Commercial Officer Robert Crockart commented, “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 of 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.”
The nasal spray is already marketed as an antiviral under the names Enovid and VirX in several countries, including Israel, Thailand, and Indonesia. NONS has also received a CE mark in Europe. In June 2021, SaNOtize announced that it had initiated a Phase 3 trial of NONS for the prevention and treatment of COVID-19 and said that it had submitted a marketing application in Canada. The global Phase 3 trial is ongoing according to the new announcement.
Read the Glenmark Pharmaceuticals press release.
