• Becomes the world's first and only clinically approved nicotine inhaler enabling rapid absorption via the lungs to help smokers replace, cut down, and ultimately quit smoking
• As a General Sales List (GSL) medicine, can be offered for sale with or without prescription and advertised on major e-commerce platforms, via pharmacies and direct to consumer channels
• Company now seeks strategic partnerships for UK and global launches

Liverpool, UK – 25/06/2024 – Ayrton Saunders Limited (Ayrtons), a pioneering smoking cessation and medical products firm, announces the approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of the world's first and only clinically approved, patented nicotine inhaler system able to deliver nicotine directly via the lungs to help smokers replace, cut down and ultimately quit smoking. The company is working to extend this landmark approval to additional markets in the EU and beyond and will explore discussions regarding regulatory and commercial pathways in the US and Japan. The company is actively seeking partners for commercial launch of this novel nicotine-replacement therapy (NRT) in the UK and other key markets, setting the stage for a significant global impact.

Using globally patented technology similar to an asthma inhaler, uniquely this innovative next-generation system enables rapid delivery via the lungs of a low dose of nicotine that quickly reaches the brain to provide fast and safe relief of craving symptoms. It has a fresh, clean taste and no noticeable smell or visible exhalate when fully inhaled. The system consists of a reusable, hand-held breath-activated inhaler device and a stable (flavoured) nicotine solution. Powered by a pressurised propellant, no batteries are required and there is no heat and no change to the chemical structure of the formulation when generating the aerosol. The product is refillable using nicotine canisters, which enables an attractive price point for the consumer.

The product has undergone extensive user testing and clinical trials, which demonstrated a bigger reduction in craving relative to the market leading inhalator device. It is now uniquely positioned in the UK market to be offered for sale (with or without prescription) and advertised on major e-commerce platforms, via pharmacies and direct-to-consumer channels that are regulatorily restricted for vapes or e-cigarettes. In addition, the product is the only MHRA-approved NRT inhaler that can deliver nicotine rapidly via the lungs that is now ready for commercial launch and can be used in public spaces such as on public transport, in restaurants and hospitals, reflecting its safe and user-friendly profile.

Ayrtons is seeking sales or licensing partners to launch the product in the UK, with subsequent ambition to expand across the EU, US, Japan and the Middle East. The annual EU NRT market opportunity is currently valued at approximately US$1 billion and expected to grow to over US$1.5 billion in the next five years, while the global market is valued at over $3.8bn1. The company has established a robust supply chain capable of delivering up to 18 million units annually with the ability to scale further with the appropriate investment.

Gerry O’Brien, Director of Ayrtons and a Fellow of the Royal College of Pharmacists, has spearheaded the development and significant re-design of this innovative next generation NRT over the past three years following initial development work by Kind Consumer Ltd. This has resulted in improved device function and user experience, while at the same time delivering a reduced price point for consumers.

“The team has worked tirelessly to reach this important milestone of MHRA approval making this product the first NRT that delivers nicotine directly for absorption in the lung,” stated Mr O’Brien. “Ten million adults in the UK smoke or vape and half of these people try to quit each year, but fewer than 3% succeed. Smoking is the leading cause of premature, preventable death in the UK and globally, so there is a crucial need for widespread access to services and products that have been shown to help smokers reduce or stop smoking safely and cost-effectively.”

He added: “The harms caused by tobacco smoking place a huge health and economic burden on society, and while currently available smoking cessation products can help, they are not appropriate for most smokers trying to quit. We are delighted to create and offer for license or sale a product that we believe will play a crucial role in helping to combat tobacco dependence and improve public health as we work towards a healthier, more smoke-free world.”

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Ref. 1. Fortune business insights: Nicotine replacement therapy market 2024

For partnership inquiries or more information, please contact:Ayrton Saunders Limited Voke@ayrtons.com

For media inquiries, please contact:MEDiSTRAVA Frazer Hall/Mark Swallowayrtons@medistrava.com

About Ayrton Saunders LimitedAyrton Saunders, part of OBG Pharma, is a speciality pharmaceutical company based in the UK focused on the development and partnering or sale of aerosol-based treatments for international markets. Ayrtons has a long history of supplying high quality products internationally to meet real patient needs. For more information see our website Speciality Pharmaceuticals | Ayrtons