Australian Firebrick Pharma (ASX:FRE) has launched its nasal spray product, Nasodine® Nasal Spray (“Nasodine”) in the United States, the first country in the world where the product has become commercially available.
Nasodine contains the broad-spectrum antiseptic agent called PVP-iodine, best known for its widespread use in throat gargles under the Betadine® brand. With Nasodine, the same ingredient is now available in a nasal spray.
Nasodine will be promoted in the US for ‘nasal hygiene’, and as the company won’t be making any therapeutic claims, it can be marketed without FDA approval.
Since the pandemic, several other PVP-iodine nasal sprays have been introduced in the US and continue to be marketed as nasal hygiene products.
“Nasodine will be the only PVP-iodine nasal spray in the US that is supported by proven safety in clinical trials and a growing list of peer-reviewed publications,” said Firebrick Executive Chairman, Dr Peter Molloy.
“Our position has always been that if we can make Nasodine available, people will use it. In a post-COVID world, where everyone is concerned about nasal hygiene, we believe Nasodine is the answer,” said Dr Molloy.
“We breathe around twenty-five thousand times a day, potentially inviting germs, allergens and other airborne threats into our noses. Nasodine can help neutralise these threats and we believe that will appealing to the US market,” said Dr Molloy.
The product will initially be available for purchase on the company’s American website (nasodine.com) and will be supported by online promotion across the US.
In the future it’s expected that Nasodine may also become available in pharmacies in the US.
“Launching Nasodine into the world’s premier pharmaceutical market is a momentous event for our company, culminating more than 10 years of R&D and heralding our transition from a biotechnology business to a commercial pharmaceutical business,” said Dr Molloy.
The company has several other PVP-iodine products in development and expects some of these to become available in the future for the US market.
“We plan to build a portfolio of products under the Nasodine brand and launch them in the US and other markets,” said Dr Molloy.
In the US, Nasodine is manufactured for Firebrick by a contract manufacturer who recently completed their first US commercial batch of finished product.
Warehousing and order fulfilment is provided by a third party logistics partner in the US.
Nasodine’s clinical trials to date have confirmed that the nasal spray is safe for human use. Recently, a peer-reviewed paper reported that it was effective in significantly reducing the viral load of SARS-Cov-2 in the nose.
Nasodine is not approved for sale in Australia, although the product may be purchased from the US website and imported for personal use under the TGA’s Personal Importation Scheme.
About us:
Firebrick Pharma is a pharmaceutical innovator focused on developing and commercialising novel formulations and uses of povidone-iodine. The Company has successfully developed a povidone-iodine nasal spray (Nasodine®) and filed international trademarks and multiple patents on the product. The Company has also completed six clinical trials for the nasal spray, which have affirmed the product’s safety and generally supported its efficacy as an antimicrobial nasal spray with utility in a range of clinical settings. Firebrick is now commercialising Nasodine in international markets.
