Big tobacco’s nicotine inhaler approved by UK regulator

A cigarette-shaped nicotine inhaler has become the first of its kind to be licensed for use in the UK.

Voke is manufactured by Nicoventures, a wholly-owned subsidiary of British American Tobacco (BAT), the world’s second largest cigarette manufacturer, in association with its development partner Kind Consumer. It is aimed at “smokers who want to reduce, replace or stop smoking”, providing a novel alternative to e-cigarettes.

The product has been granted an initial medicines licence by the Medicines and Healthcare products Regulatory Agency (MHRA). It is the first “alternative to smoking” to be approved by the agency, which up until now has only licensed products intended to be used as nicotine replacement therapy.

The product, which is not yet available to buy, will be a general sale list product, so it may be available from a wide range of outlets as well as from pharmacies that choose to stock it.

Electronic cigarettes, none of which have yet been licensed by the MHRA, usually contain a battery and a nicotine solution that is heated and vaporised. Users then inhale the vapour through the end of the e-cigarette. In contrast, the Voke inhaler has a small aerosol can containing a pressurised nicotine solution and a stick device that needs to be filled from the can. Once filled, the stick device is breath-operated and the nicotine is inhaled, delivering much of the experience smokers expect from a cigarette, including a “throat catch”, but “without the serious health risk of smoking”.

Kind Consumer will now be pursuing a variation to the licence for a further evolution of the technology that will support automated manufacture of the product by Nicoventures.

“Considerable work has already been completed to support this process,” said Des Naughton, Nicoventures’ managing director.

Nicoventures says the granting of the initial medicines licence is “a major step forward in BAT’s commitment to offering smokers a choice of satisfying safer alternative products”. BAT already produces a conventional e-cigarette called Vype.

After the first approval of this kind, the MHRA is encouraging other companies to submit applications for similar products.

“We have licensed the Voke inhaler as a medicine and this means it is a product of acceptable quality and can be an effective aid to smoking cessation,” it says. “The MHRA continues to encourage and actively support companies to submit medicines licence applications for electronic cigarettes and other nicotine-containing products, which can be used in stop-smoking services.”

The Royal Pharmaceutical Society (RPS), the professional body for pharmacy in Great Britain, reiterated its policy that all nicotine-containing products should be licensed and so it does not support the sale of unlicensed e-cigarettes in pharmacies.

With the introduction of Voke, Neal Patel, RPS head of corporate communications, said the RPS supports the use of licensed medicines for conditions as the first option when choosing therapy. However, Patel believes there is an ethical dilemma for pharmacists in supporting the sale of products owned and promoted by tobacco companies.

“Many of the public policies actively pursued by the government and NHS agencies – and supported by the RPS – focus on stopping initial uptake of tobacco through higher taxes, and restricted advertising and use,” Patel says. “The fact that tobacco manufacturers are now entering the health space probably needs some careful thinking through. We would be very concerned if tobacco interests are represented in public health discussions or if attempts are made to influence the views of health professionals about tobacco.”

It is not known when Voke will be available or how much it will cost.

“Voke has been designed with smokers in mind to provide both the nicotine they want as well as to mimic the habits and rituals that are part of the smoking habit,” a spokeswoman for Nicoventures says. “In that context, we will be pricing Voke to be competitive with cigarettes.”