Israel and New Zealand have given interim approval for the sale of biotech firm SaNOtize Research and Development's Nitric Oxide Nasal Spray (NONS) which could help prevent transmission of the COVID-19 virus.
Manufacturing of NONS, under the brand name Enovid, has begun in Israel with SaNOtize's partner Nextar Chempharma Solutions Ltd and it is expected to be on sale there this summer.
In New Zealand, SaNOtize has registered its nasal spray with the New Zealand Medicines and Medical Devices Safety Authority, which permits the company to distribute and sell NONS over the counter immediately, the Vancouver-based company said.
However, New Zealand's health ministry said it has not approved the product for use as an anti-viral nasal spray.
The approval referred to by the company may relate to a notification made to the New Zealand Web-Assisted Notification Database (WAND) operated by Medsafe, where medical devices for supply in New Zealand are required to be notified. This is not an application or approval process, the health ministry said in a statement on Tuesday.
"The presence of an entry on this database does not confirm or imply that the product meets the requirements of the Medicines Act 1981," it said in a statement, adding that it would follow up with the company.
Last week, SaNOtize and Ashford and St Peter’s Hospitals NHS Foundation Trust in Surrey, UK announced results of clinical trials showing that NONS was an effective antiviral treatment that could prevent the transmission of COVID-19, shorten its course, and reduce the severity of symptoms and damage in those already infected.
“I expect this to be a major advance in the global battle against the devastating human impacts of the COVID-19 pandemic," said Dr. Stephen Winchester, Consultant Medical Virologist and Chief Investigator of this NHS Clinical Trial.SaNOtize is applying to regulatory authorities in the UK and Canada for Emergency Use authorization.
Source: thefederal.com