Amsterdam, Netherlands, 5 January 2016 - A new study, published in the Journal of Regulatory Toxicology and Pharmacology, found that e-cigarettes share a similar short-term safety profile as Nicorette® products and are comparable in reducing tobacco withdrawal symptoms.

The study, conducted by Fontem Ventures scientists, used a prototype vaping product with two percent nicotine concentration - the maximum limit prescribed by the EU Tobacco Products Directive - and found it delivered sufficient nicotine to suppress smoking desire.

"Unlike other nicotine replacement therapies, the vaping product we studied may offer a viable alternative to cigarettes for those finding it difficult to quit the behavioural and sensorial aspects of smoking," said Tanvir Walele, Senior Scientist at Fontem Ventures." The e-cigarette was well tolerated in smokers, had a similar short-term safety profile to Nicorette®, and clearly has the potential for use as an aid for smoking reduction or cessation."

Many smokers fail to quit because current nicotine replacement therapies do not deliver nicotine in the same way as conventional cigarettes, nor do they provide the unique sensory cues or rituals associated with the use of conventional cigarettes. A growing number of smokers are therefore choosing vaping products to quit or reduce their cigarette consumption, and to relieve tobacco withdrawal symptoms.

"By clinically evaluating the acute effects of vaping on nicotine blood levels and its short-term potential for reducing smoking desire and withdrawal symptoms, this research shows that e-cigarettes offer a smokers a legitimate aid to reduce or cease tobacco consumption, providing the products comply with safety, quality and efficacy standards set by a medicinal regulator," said Tanvir Walele.

Abstract

"A Randomized, Crossover Study on an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette. Part A: Pharmacokinetics"

The pharmacokinetic (PK) profile of nicotine delivered by an Electronic Vapour Product (EVP) was characterised in a 2-part study in smokers. The study was designed as a randomised, controlled, four-way crossover trial. Part 1 compared an unflavoured e-liquid (UF2.0%) and a flavoured e-liquid (FL2.0%) to a conventional cigarette (CC; JPS Silver King Size, 0.6mg) and a licensed nicotine inhalator (Nicorette®; 15mg). Part 2 compared e-liquids with increasing nicotine concentrations (0%, 0.4%, 0.9%, 2.0%). Subjects used each different product for a daily use session. In Part 1, maximum plasma nicotine concentration (Cmax) for UF2.0%, FL2.0%, Nicorette® and CC was 3.6, 2.5, 2.5 and 21.2 ng/mL, respectively. The time to maximum plasma nicotine concentration (Tmax) was longer for the EVP (UF2.0%, 9.0 min; FL2.0%, 10.0 min) and the nicotine inhalator (13.0 min) compared to CC (3.0 min). In Part 2, EVP with 0%, 0.4%, 0.9% and 2.0% nicotine produced Cmax values of 0.6, 1.0, 1.9 and 3.6 ng/mL, respectively. At the maximum nicotine concentration of 2% as prescribed by the European Tobacco Directive, the EVP achieved nicotine delivery that was comparable to the inhalator. EVPs thus offer a potential alternative to nicotine inhalator devices for those finding it difficult to quit smoking.

"A randomized, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part B: Safety and subjective effects"

An Electronic Vapour Product (EVP) and has been evaluated for short-term safety parameters and subjective effects in a 2-part study, in smokers. Part 1 compared the EVP with unflavoured (UF) and flavoured (FL) e-liquid at 2.0% nicotine to a conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine inhalator (Nicorette®, 15 mg). Part 2 assessed the effect of increasing concentrations of nicotine in the e-liquid used with the EVP (0%, 0.4%, 0.9%, 2.0%). The study was designed as a randomised, controlled, crossover trial. Outcomes included adverse events (AEs), vital signs, exhaled carbon monoxide (CO), clinical laboratory parameters, smoking urges and withdrawal symptoms. In both study parts, only mild non-serious AEs were reported. No major differences were observed in AEs between the EVPs and Nicorette®. Exhaled CO levels only increased for CC. All products appeared to decrease smoking urges and nicotine withdrawal symptom scores to a similar extent. The EVP had a similar short-term safety profile to Nicorette® and relieved smoking urges and nicotine withdrawal symptoms to a similar extent as Nicorette® and CC. Unlike nicotine replacement therapies, the EVP may offer an alternative for those finding it difficult to quit the behavioural and sensorial aspects of smoking.

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Published study

To view the full research paper, please visit: http://www. sciencedirect. com/ science/ article/ pii/ S0273230015301380 (Part A) and http://www. sciencedirect. com/ science/ article/ pii/ S0273230015301392 (Part B)

About Fontem Ventures

Fontem Ventures is the owner of blu, a leading e-cigarette brand in the United States and the United Kingdom. Headquartered in the Netherlands, and present on two continents, Fontem Ventures is an innovative consumer goods company, founded in 2012, committed to developing a portfolio of products that meet consumer needs, including the highest quality electronic vaping products.