Biohit Oyj - Inside information

Biohit Acetium® lozenge is a highly effective means to stop smoking – results confirmed in a new large-scale trial

Biohit Oyj Inside Information May 22, 2017 at 9:30 am local time (EEST)



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