Ayrton Saunders has received the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approval for its patented nicotine inhaler system to help users quit smoking.

The company said that its new-generation nicotine inhaler system is the world’s first and only clinically approved nicotine replacement therapy (NRT).

The nicotine inhaler system is designed to deliver nicotine directly through the lungs to help smokers replace, reduce, and ultimately quit smoking.

After initial development work by Kind Consumer, Ayrton’s director Gerry O’Brien led the development and significant re-design of the next-generation NRT over the past three years.

The re-design has resulted in improved device function and user experience while delivering a reduced price point for consumers, said the British medical device company.

O’Brien said: “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.

“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.”

Ayrton’s NRT system leverages a patented technology that works like an asthma inhaler and enables rapid delivery of a low dose of nicotine through the lungs.

The system comes with a reusable, hand-held breath-activated inhaler device and a stable (flavoured) nicotine solution with a fresh, clean taste and no noticeable smell when inhaled.

Powered by a pressurised propellant, the system requires no batteries and involves no heat or change in the chemical structure of the formulation when generating the aerosol.

Ayrton said that its NRT system has been evaluated in extensive user testing and clinical trials, which showed a superior reduction in craving compared to the other inhalator devices.

The company aims to extend the approval to additional markets in the EU and beyond and explore discussions regarding regulatory and commercial pathways in the US and Japan.

Furthermore, Ayrton is seeking partners to support the commercial launch of its NRT in the UK and other key markets worldwide.

O’Brien 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.”