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Commit®
 Geared to help smokers quit
Proven efficacy with low level of behavioral intervention
- In a large clinical trial (>1,800 subjects), 49% of the Commit 4 mg users remained smoke free at 6 weeks vs 21% for placebo ( P<0.001)6
- 46% of 2 mg Commit users were smoke free at 6 weeks vs 30% for placebo ( P<0.001)6
- Abstinence rate achieved with 4 brief behavioral intervention contacts (5 to 10 minutes)6
Proven efficacy even for the more challenging smokers
- Highly dependent smokers9*
- Smokers previously unsuccessful on prior pharmacological treatment10 4 mg Commit reduces weight gain associated with quitting
- 4 mg Commit users experienced less weight gain compared with placebo: 2.3 lb less at 6 weeks; 1.6 lb less at 12 weeks; weight gain was equal at 6 months6
Easy-to-select dosing strength based on dependency

* Results with Commit 4 mg. Includes smokers who scored >7 on the Fagerström Test for Nicotine Dependence.
† Minimum recommended lozenge/day = 9. Maximum recommended lozenge/day = 20.
Established Heritage

- Over 5 million smokers worldwide have quit smoking with the help of Commit and other NRT products from GlaxoSmithKline2
Commit: proven smoking cessation with
low level of behavioral intervention
Intensive interventions in clinical trials may not mirror real-world practice3
Patients in Commit trial had considerably fewer behavioral intervention
contacts than patients in ChantixTM (varenicline tablets) trials

Sources:
1. Chantix [Product Information]. New York, NY: Pfizer Inc; 2006.
2. Data on file. GlaxoSmithKline.
3. Solberg LI, Asche SE, Boyle RG, Boucher JL, Pronk NP. Frequency of physician-directed assistance for smoking cessation in patients receiving cessation medications. Arch Intern Med. 2005;165:656-660.
4. Shiffman S, Dresler CM, Hajek P, Gilburt SJA, Targett DA, Strahs KR. Efficacy of a nicotine lozenge for smoking cessation. Arch Intern Med. 2002;162:1267-1276.
5. Jorenby DE, Hays JT, Rigotti NA, et al, for the Varenicline Phase 3 Study Group. Efficacy of varenicline, an 2 4 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006;296:56-63.
6. Gonzales D, Rennard SI, Nides M, et al, for the Varenicline Phase 3 Study Group. Varenicline, an 2 4 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006;296:47-55.
Proven efficacy
4 mg Commit doubles quit rates with
low level of behavioral intervention1

Smoke-free 4 mg Commit users1
- 49% at 6 weeks (vs 21% for placebo; OR [odds ratio] 3.69)
- 35% at 12 weeks (vs 14% for placebo; OR 3.42)
- 15% at 52 weeks (vs 6% for placebo; OR 2.69)
Compliance improves efficacy1

- Quit rates were 57% (30% placebo) at 6 weeks for those smokers in the 4 mg lozenge group who used more than 9 lozenges per day in the first 2 weeks1
- The minimum dosage in the first 6 weeks is 9 lozenges per day
Recommend first line
Proven efficacy even for the more challenging smokers
- Heavily addicted smokers3: FTND* >7
- Smokers with a history of unsuccessful quit attempts including those using pharmacological treatment4
- — In a study of 1,818 smokers, over 80% of participants had made at least one previous quit attempt and 63% had previously tried using a pharmacologic agent
Reduces weight gain associated with quitting
4 mg Commit users experienced less weight gain compared with placebo1
- 2.3 lb less at 6 weeks
- 1.6 lb less at 12 weeks
- Weight gain in the placebo and treatment groups was equal at 6 months
Excellent Safety
- Commit can be used safely even in patients with cardiac disease, diabetes, and hypertension5
* Fagerström Test for Nicotine Dependence. An FTND >7 identifies a highly dependent smoker.
Sources:
1. Shiffman S, Dresler CM, Hajek P, Gilburt SJA, Targett DA, Strahs KR. Efficacy of a nicotine lozenge for smoking cessation. Arch Intern Med. 2002;162:1267-1276.
2. Data on file. GlaxoSmithKline
3. Shiffman S, Di Marino ME, Pillitteri JL. The effectiveness of nicotine patch and nicotine lozenge in very heavy smokers. J Subst Abuse Treat. 2005;28:49-55.
4. Shiffman S, Dresler CM, Rohay JM. Successful treatment with a nicotine lozenge of smokers with prior failure in pharmacological therapy. Addiction. 2004;99:83-92.
5. Marsh HS, Dresler CM, Choi JH, Targett DA, Gamble ML, Strahs KR. Safety profile of a nicotine lozenge compared with that of nicotine gum in adult smokers with underlying medical conditions: a 12-week, randomized, open-label study. Clin Ther. 2005;27:1571-1587.
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Nicorette®
In a major clinical trial, the popular nicotine replacement therapy (NRT) product, Nicorette® (nicotine polacrilex gum) was also proven effective in relieving situational cravings. This multi-center, randomized, placebo-controlled study was conducted with smokers (n=296) who quit by using either active gum (Nicorette 4 mg for heavy smokers; 2 mg for light smokers) or inactive gum (control) for 3 days. On the 3rd day, participants were exposed to strong situational stimuli (ie, handling cigarettes; smelling cigarette smoke), after which they were allowed to chew the gum. Cravings assessment scales in 167 participants identified as "reactors" to stimuli demonstrated that:
- Use of Nicorette resulted in significantly greater reductions in craving (F1,285=13.81, P<0.001) than control1
- Craving dropped significantly faster among subjects using active gum (F1,158=10.65, P=0.001) compared to control1
- In minutes 10-15, subjects using active gum showed significantly steeper drops in craving (F1,158=7.35, P=0.008); by 15 minutes, and at every time point thereafter, participants on active gum demonstrated significantly lower craving than those on control1
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Sources:
1. Durcan MJ, De’Ath J, Targett D, Marsh H, Chan R, Ong TJ (2003) Efficacy of the nicotine lozenge in relieving cue provoked cravings. Poster presented at the annual European meeting of the Society for Research on Nicotine and Tobacco, Padua, Italy.
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