The second smoking intervention study started in 2016 with Biohit Acetium lozenge has been completed confirming the efficacy of Acetium lozenge as an effective way to assist in smoking cessation. This new trial was designed to be adequately powered to confirm the results of the first intervention study indicating that Acetium is a potential new tool in assisting smoking cessation (1). This novel indication of Acetium lozenge is based on its capacity to effectively bind cigarette smoke-derived acetaldehyde in the saliva (2), thus potentially reducing the known effects of acetaldehyde in the maintenance of smoking dependence (3).
In this new double-blind, randomized intervention trial, a cohort of 1998 volunteer smokers was enrolled, randomly allocated into two study arms of equal size: Acetium (n=996) and Placebo (n=1002). Except for a shorter duration (6 months instead of 12), the study setting was similar as in the first study (1); smokers were instructed to continue their regular smoking habits, one group using Acetium lozenge and the other group using placebo lozenges with each smoked cigarette. The most important study instrument was the smoking diary recording the use of cigarettes and lozenges as well as different sensations of smoking experience on daily basis. Customary to clinical trials, the results were analysed separately for the study subjects who followed the protocol to perfection (PP), and for those who did so with minor violations (mITT).
The principal investigator, Chief Medical Director of Biohit Oyj, Professor Kari Syrjänen: ‘Having now been confirmed in an adequately powered study, these results represent a breakthrough in the development of smoking intervention methods. The new intervention trial closely reproduces the results of the first study (1), confirming that Acetium lozenge is markedly more effective than placebo in assisting smoking cessation. This study is also adequately powered to confirm the statistical significance of these results. In the Acetium (PP) arm, 45.3 % could stop smoking as compared to 35.4% in the placebo group (i.e., Acetium was 27.9 % more effective) (p=0.004). Statistically this is a remarkable difference. Compared to the placebo, the likelihood of smoking quit among Acetium users was 1.51-fold (95 % Confidence Interval 1.12 - 2.02) (p=0.006). This efficacy favorably competes with the results reported for nicotine replacement therapy (NRT) (4), and most importantly, even with the efficacy (i.e., OR 1.5) of the most effective current medication (combination of bupropion and varenicline) (5).’
CEO Semi Korpela, Biohit Oyj: ‘Acetium lozenge is a safe and efficient smoking cessation product. No side effects. No nicotine dependencies. The efficacy is comparable to nicotine replacement therapy. The study result confirms that the Biohit Oyj innovation represents a breakthrough in the smoking cessation product market currently dominated by two main product types, prescription drugs and nicotine replacement. The product is CE-marked and available. Cessation of smoking is not easy, and in all cases, the final decision to quit has to be made in person. Acetium lozenge has an added clinical value while effectively eliminating smoking-derived carcinogenic acetaldehyde in the saliva (2) and promoting oral health. Biohit Oyj recommends refraining from smoking because of its known multiple health hazards.’
References:
1. Syrjänen K, Salminen J, Aresvuo U, Hendolin P, Paloheimo L. Eklund C, Salaspuro M, Suovaniemi O. Elimination of cigarette smoke-derived acetaldehyde in saliva by slow-release L-cysteine lozenge is an effective new method to assist smoking cessation. A randomised, double-blind, placebo-controlled intervention. Anticancer Res 2016;36:2297-2306.
2. Salaspuro VJ, Hietala JM, Marvola ML, Salaspuro MP. Eliminating carcinogenic acetaldehyde by cysteine from saliva during smoking. Cancer Epidemiol Biomarkers Prev 2006;15:146-149.
3. Talhout R, Opperhuizen A, van Amsterdam JG. Role of acetaldehyde in tobacco smoke addiction. Eur Neuropsychopharmacol 2007;17:627-636.
4. Lemmens V, Oenema A, Klepp KI, Brug J. Effectiveness of smoking cessation interventions among adults: a systematic review of reviews. Eur J Cancer Prev 2008;17:535–544.
5. Vogeler T, McClain C, Evoy KE. Combination bupropion SR and varenicline for smoking cessation: a systematic review. Am J Drug Alcohol Abuse 2016;42:129–139.
Additional information:
CEO Semi Korpela, Biohit Oyj
tel. +358 9 773 861
investor.relations@biohit.fi
www.biohithealthcare.com
Biohit in brief
Biohit Oyj is a globally operating Finnish biotechnology company. Biohit mission is “Innovating for Health” – we produce innovative products and services to promote research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit Series B share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com
