“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.”
The media release is below.
###
PUBLIC RELEASE: 5-JAN-2016
E-cigarettes deliver sufficient nicotine to suppress smoking desire and reduce tobacco withdrawal symptoms in smokers, comparable to Nicorette
FONTEM VENTURES
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.
###
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.
To my mind, the advantage of vaping over the patches and gums is that it addresses the nervous energy factor. Unlike other approaches, it give you something to do with your hands, same as smoking cigarettes. From a marketing approach, that makes it a success inasmuch as – Marketing 101 here – you only change one thing at a time in product evolution and development, in this case substituting relatively cool steam for the searingly hot combustion gasses of burning leaves.*
That said, it still *looks* like smoking in the traditional sense. That has the Puritans and Prohibitionists in a tizzy, pointing to the pleasurable flavours available and trotting out ever predictably the “The Children” argument as rationales for restricting its use and availability.
The anecdotal evidence is that vaping has both increased lung function in its users and has aided them in quitting tobacco use altogether. Thus, you have to wonder if much of this prohibitionist hysteria is funded by those whose profits are most threatened most by vaping – Pharma and Tobacco Companies. Doubtless you can add a probable decline in tax revenues to the incentives to restrict its use as well. And this makes it a sort of a perfect storm of what’s know as a disruption product.
Just a thought.
VicB3
*And that would include the suspect gases produced by burning cigarette paper as well.
Yeah, but the addiction to tobacco taxes makes leftists crazy.
Until they can tax and regulate e-cigs near to death, they will have an unbearable craving.
What about the “Vapos” ? $75 got me a Joyetech eGo One. Goal quit smoking after 17 yrs., this is working FAST. Made in China, bought local Santa Cruz Ca., new Vap store owned by a fine person. My 17 yr old daughter provoked this expenditure. CARTON of American Spirits Ca. $78.00
The important thing is that there is no smoke to inhale. Nicotine is only dangerous by itself if the dose is large enough, and the e-cigarettes control the dose very well.
The carcinogens from cigarettes are in the smoke.