UK brand applies to MHRA for novel nicotine replacement therapy device

UK medical device manufacturer Ventus Medical has submitted a marketing authorisation application for an inhaling device to be used as a nicotine replacement therapy (NTR) in the UK.

The company’s submission to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) was filed earlier this month for Enhale, a nicotine-based product the brand said can be used to quit both smoking and vaping.

Ventus said in a note that the device, which uses replaceable nicotine cartridges, works through a low-temperature vaporisation system that ensures a higher safety level than traditional vaping products.

“The maximum heating temperature is only around 150 degrees C,” the brand’s co-founder David Lawson told ECigIntelligence.

“This is particularly important,” he added, “as the lower temperature prevents any thermal degradants, making Enhale the safest inhaled nicotine product.”

Lawson said the new device emits a less visible vapour cloud. This makes it easier to use in public places, as the formulation of the single-use nicotine cartridges it works with is semi-solid and, unlike that of traditional vapes, free from propylene glycol (PG) and vegetable glycerin (VG).

“The reason for this is to minimise the visible plume so that Enhale can be used discretely and in places where others may be concerned,” he said, “for example, in an office or on a plane.”


Looking at Europe


Ventus Medical said the device, once approved, will be available across the UK without prescription.

In the meantime, the company will submit for approval in Europe.

“The review process is likely to take a year with the MHRA,” Lawson said, “and, during this period, we will be submitting to Europe, too.”

“We are now planning the commercialisation for the UK product launch,” he added, “which should take place in late 2025, early 2026.”

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    Ruling out flavours


    Lawson said that, for the time being, Enhale is intended as a neutral product in terms of flavours, in order to avoid attracting young users – although a limited offer of aromas is being developed for the US market.

    “Due to the risk of youth use, Enhale is currently available only as a clear product,” he said.

    “However, tobacco, mint, menthol and fruit mint formulations have been developed for the US market,” he added, “which are intended as adult aromas rather than flavours.”


    Different from e-Voke


    In 2014, the UK MHRA delivered another medical licencing for a vaping device, e-Voke, then marketed by British American Tobacco (BAT), which was the first – and is to date the only – e-cigarette-type device to be authorised as an NRT tool.

    This time, Ventus Medical said, the product it is submitting is different and safer than vaping devices currently on the market.

    Lawson said, based on a clinical study the company conducted in the UK against the market-leading Nicorette NRTs, namely QuickMist and Inhalator, “Enhale was shown to alleviate withdrawal symptoms much quicker than other products, likely quicker than vaping too”.

    “There is an urgent need for regulated, safer alternatives to vaping products and cigarettes,” said the company’s chairman Kaasim Mahmood, who is also general partner at Advent Life Sciences –which took part in the development of Voke over ten years ago.

    “Enhale has been designed and developed following extensive consultation with physicians, healthcare professionals and smokers who require a medicinal alternative to tobacco products,” said Mahmood.

    – Tiziana Cauli ECigIntelligence staff

    Tiziana Cauli

    Senior reporter/health & science editor
    Tiziana is an Italian journalist from Sardinia. She has worked for both international and local media in Italy, South Africa, France, Spain, the UK, Lebanon and Belgium. She also worked as a communications manager for several international NGOs in the humanitarian sector. Tiziana holds a degree in Political Science and a PhD in African Studies from the University of Cagliari and she’s a graduate of the Carlo De Martino school of journalism in Milan.

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