Ayrton Saunders Announces Landmark UK MHRA Approval of Next Generation Nicotine Inhaler System for Rapid, Safe Relief of Nicotine Craving to Aid Smoking Cessation
25 June 2024 - 5:00PM
- 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