Summary
Introduction
Sublingual nicotine tablets are an established form of nicotine replacement therapy (NRT) used for smoking cessation.
A new formulation of Nicorette® Microtab containing nicotine hydrogen tartrate (NHT) was developed and shown to be bioequivalent to the existing formulation.
This study evaluated the local oral tolerability of the new sublingual nicotine tablet during prolonged use.
Key Points
Study design: Open-label, single-centre Phase II study with 50 adult smokers over a 16-week follow-up (12 weeks of active treatment).
Dose and use: Participants used a 4 mg sublingual tablet, typically 8–12 tablets/day, with high compliance.
Assessment methods: Oral mucosa was visually inspected at each visit, photographed, and biopsied at the site of tablet placement after 12 weeks.
Local oral effects:
Most observed lesions were mild to moderate, superficial, and consistent with friction-induced keratotic changes.
Histological analysis showed no deep epithelial damage, basal layer thickening, or dysplastic changes.
Adverse events: Treatment-related adverse events were mild, tolerable, and transient, most commonly hiccups, nausea, dry mouth, oral irritation, cough, and gastrointestinal symptoms.
Reversibility: Lesions improved or resolved after discontinuation of tablet use, supporting a reversible effect.
Smoking status: A subset of participants achieved abstinence by the end of treatment, indicating concurrent cessation benefit.
Conclusion
The new sublingual nicotine tablet demonstrated good local tolerability during 12 weeks of use.
Oral mucosal changes were benign, superficial, and reversible, consistent with mechanical irritation rather than toxic effects.
The safety profile aligns with existing NRT products, supporting the continued use of sublingual nicotine tablets as a safe option for smoking cessation.
Citation
Sand, Lars, et al. “Local Tolerance of a Sublingual Nicotine Tablet, an Open Single-Centre Study.” In Vivo, vol. 26, no. 3, 2012, pp. 463–468.
