UK pharma regulator approves cigarette-like vapour device

Voke 300x180Britain’s medicines regulator has issued a product licence for the nicotine inhaler Voke, which will be sold by British American Tobacco’s subsidiary Nicoventures and looks likely to be the closest pharmaceutically-approved competitor to the e-cigarette.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has given the Voke Inhaler 0.45mg a licence for general sale, meaning that it can be sold in general retail outlets without the supervision of a pharmacist.

Its developer Kind Consumer – which signed an agreement with Nicoventures in 2010 for the latter to commercialise Voke – says it is “for use to relieve and/or prevent craving and nicotine withdrawal symptoms” but, significantly, adds that as well as being indicated for smokers trying to reduce or quit, it can also be used “to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them”.

The MHRA approval also means that Voke could be provided to consumers free, or via subsidised prescriptions, through the National Health Service (NHS) and its smoking cessation services.

Cigalikealike

Visually, Voke strongly resembles an e-cigarette – and indeed a tobacco cigarette – but the technology is quite different.

Instead of a nicotine-containing liquid being heated by a battery to produce a visible vapour, Voke uses pressure to atomise the nicotine. An invisible vapour is inhaled by the user through a breath-operated valve.

“You can use Voke as you would a cigarette and inhale as much as desired,” says Kind Consumer, and the product is said even to mimic the “throat catch” of smoking.

The system is being marketed in a configuration that appears designed to compete with the 20-pack of combustible cigarettes, the most common format in Britain.

The Voke stick will be sold in a case from which it can be refilled 20 times, with 0.43mg delivered from each of those 20 charges (except the first one, for design-related reasons).

Each charge thus delivers approximately the same amount of nicotine as a single cigarette, through a similar number of puffs. The entire refill pack is roughly equivalent in nicotine content to a 20-pack of combustible cigarettes, and will be priced “competitively” with them, Nicoventures said.

Said Chris Moyses, Kind Consumer’s chief medical officer: “The technology contains no electronics, heat or combustion, and will rival e-cigarettes and nicotine replacement therapies when launched.”

A paper published in August in the journal Nicotine & Tobacco Research, “Evaluation of a novel nicotine inhaler device”, compared Voke with Johnson & Johnson’s 10mg Nicorette Inhalator and found it “at least as effective…despite lower total nicotine exposure”.

Coming soon

Voke is expected to be launched in the first half of next year, the culmination of more than a decade of development, although design modifications to allow automated manufacture still have to pass through a further MHRA approval process.

The product will be manufactured in Britain by Bespak, part of Consort Medical, which specialises in inhalers or “puffers” for asthma and chronic obstructive pulmonary disease. That company describes factory preparations as “well advanced”.

British American Tobacco (BAT) already sells an e-cigarette, Vype, and may collaborate with Reynolds American – in which it is a major shareholder – in taking the latter’s Vuse e-cig to international markets.

BAT’s involvement in Voke met with a lukewarm welcome from Deborah Arnott, chief executive of the British charity Action on Smoking and Health (ASH). She told The Independent newspaper: “There is an ethical dilemma and we’d much rather it wasn’t BAT that had the licence, but unfortunately when Kind Consumer were looking for investment, no-one else was interested. Medicine regulation is really important to ensure that products are of an appropriate standard. If we want the tobacco industry to stop producing tobacco…they have to be allowed to move into other areas.”

What This Means: ASH’s Arnott will not be the only person with misgivings about Big Tobacco’s involvement, but they may well be outnumbered by those – both in the healthcare professions, and among consumers – who can’t quite decide whether they trust the safety claims made for e-cigarettes, and are more comfortable with an officially-approved product.

For Voke is, clearly, going to be an alternative to an e-cigarette as much as it is another choice on the menu of pharmaceutical aids to cessation. The design (much more cigarette-like than the Nicorette Inhalator), the price point, and Kind Consumer’s own descriptions of the product make that clear.

It is hardly going to wipe out its e-cig competitors overnight (and it is unlikely to make a dent in demand for tank systems, whose users are already convinced of e-cigs’ virtues) but – assuming its quality is satisfactory – it could well become a significant player at the cigalike end of the market, particularly among new users. Much will depend on how it is marketed, and it will also be interesting to see how Nicoventures now differentiates the Vype brand.

– Barnaby Page ECigIntelligence staff

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