### **Introduction**
This summary provides an overview of a clinical study evaluating the pharmacokinetics, safety, and efficacy of 1 mg and 2 mg nicotine bitartrate lozenges (Nicotinell®) compared to nicotine gum. The study includes multiple randomized controlled trials assessing nicotine delivery, safety profiles, and smoking cessation outcomes. Readers will gain insights into the bioequivalence of these formulations, their safety in cases of misuse, and their effectiveness in helping smokers quit.
### **Key Points**
- **Study Design:**
- Three pharmacokinetic (PK) trials compared 1 mg and 2 mg Nicotinell lozenges with 2 mg and 4 mg nicotine gum.
- One safety trial assessed the effects of swallowing up to 12 lozenges.
- Two efficacy trials (France and USA) evaluated the 1 mg lozenge in smoking cessation over one year.
- **Pharmacokinetics:**
- The 1 mg lozenge was bioequivalent to 2 mg gum, delivering similar nicotine levels.
- The 2 mg lozenge provided intermediate nicotine exposure between 2 mg and 4 mg gum.
- Nicotine absorption was dose-proportional between 1 mg and 2 mg lozenges.
- **Safety:**
- Adverse events (AEs) were mild and reversible, with no serious safety concerns.
- Even when misused (swallowing 12 lozenges), no significant toxicity was observed.
- **Efficacy:**
- The 1 mg lozenge significantly increased short-term smoking abstinence rates compared to placebo.
- In France, the odds ratio (OR) for abstinence was 1.72 (95% CI: 1.05–2.80).
- In the USA, the OR was 2.87 (95% CI: 1.18–6.97), particularly in highly dependent smokers.
- **Self-Titration Behavior:**
- Smokers adjusted lozenge intake based on cravings, with higher consumption in more dependent individuals.
### **Main Message**
The study demonstrates that Nicotinell lozenges are a safe and effective option for smoking cessation, with pharmacokinetic profiles comparable to nicotine gum. The 1 mg lozenge was bioequivalent to 2 mg gum, while the 2 mg lozenge provided intermediate nicotine exposure. Both formulations were well-tolerated, even in cases of misuse, and significantly improved short-term abstinence rates. These findings support the use of Nicotinell lozenges as a valuable addition to nicotine replacement therapy (NRT) options for smokers seeking to quit.
Citation
Dautzenberg, B., Nides, M., Kienzler, JL. et al. Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell®). BMC Clin Pharmacol 7, 11 (2007). https://doi.org/10.1186/1472-6904-7-11
