Regev says the spray was originally developed to treat the flu several years ago, but a lengthy drug trial process in various countries delayed its market launch for Covid-19. In the European Union, like in India, the spray has been approved as a medical device, which means that the approval process was faster than drug trials. In some countries, regulations will require it to be approved as a drug because nitric oxide was previously allowed to be used for babies as a drug, Regev says.
“The way we deliver the nitric oxide is a much lower dose, it’s very safe. Drug approval takes longer, you have to do a lot more trials, you have to spend a lot more money and unfortunately it takes longer… This is a topical nitric oxide, non-systemic, low dose, some countries are allowing it as a medical device, for which the bar is not as high to show clinical trials. And you can get it to market sooner,” she says.
The spray releases a small amount of nitric oxide into the nose which acts as an anti-infective; it kills the virus in the upper respiratory tract, preventing it from incubating and spreading to the lungs.
“We call it the hand sanitizer for the nose. The idea was that people could carry it in their pockets and use it to avoid contracting the disease. If you are infected and the virus is in your nose and starts to multiply, the nasal spray will reduce the viral load to such an extent that it will not cause illness,” Regev said in a Zoom call, adding that in some countries it has already been cleared for use as an over-the-counter preventative measure for people aged 12 and over.