Pharmaceutical company Firebrick Pharma (ASX: FRE)’s Nasodine Nasal Spray has been launched in the United States and can now be purchased from the Company’s US website with online promotions will commencing this week across the US. 

In the US, Nasodine will be promoted for ‘nasal hygiene’ without any therapeutic claims. Based on legal advice obtained by the Company, this allows Nasodine to be marketed without FDA approval. Since 2020, multiple PVP-I nasal sprays have been introduced in the US and continue to be marketed this way. 

Firebrick Executive Chairman Dr Peter Molloy said, “Nasodine will be the only PVP-I nasal spray in the US that is supported by demonstrated safety in clinical trials and a growing list of peer-reviewed publications. 

“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.” 

Firebrick Pharma specialises in pharmaceutical innovation centred on povidone-iodine formulations. Nasodine, its flagship product, has undergone six clinical trials affirming its safety and indicating efficacy as an antimicrobial nasal spray across various clinical settings. 

In H1 FY24, the Company reported a loss of $898k in H1 FY24, an improvement from the previous corresponding period’s loss of $3.1 million. Additionally, Firebrick received an R&D Tax Incentive payment of $1,816,127 for eligible R&D expenditure. As of December 31, 2023, cash and cash equivalents stood at $1.3 million, down from $2.3 million as of June 30, 2023.

In the US, Nasodine is manufactured for Firebrick by a contract manufacturer who recently completed its first US commercial batch of finished product. A third-party logistics partner provides warehousing and order fulfilment in the US. For marketing, Firebrick has engaged a US-based online marketing agency to develop and execute a social media advertising campaign. 

The launch follows the granting of a new patent in the US specifically protecting the use of Nasodine and any other intranasal povidone-iodine (PVP-I) preparations containing 0.10-1.25% PVP-I as a method of decreasing the release of infective SARS-CoV-2 from the nose. 

“We plan to build a portfolio of products under the Nasodine brand and launch them in the US and other markets. 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 to a commercial pharmaceutical business,” added Dr Molloy.

Even as it progresses in the US, the Company hasn’t had similar luck back home. Nasodine has not been approved for marketing in Australia as a treatment for the common cold. Firebrick will continue discussing potential pathways to Nasodine’s approval in Australia with the Therapeutic Goods Administration (TGA). In the meantime, Australians can buy Nasodine from the US website and import it for personal use under the TGA’s Personal Importation Scheme. The Company also has a patent covering Nasodine in COVID-19 was granted in South Africa. 

As for the US, Nasodine will initially be marketed online only, although it is also expected to be available in pharmacies. The online retail price for Nasodine is US$24.99 (AUD $38.90).

The Company has several other products in development and expects some of these to become available in the US market in the future.