Abstract
Rationale A clinically limiting feature of currently-available nicotine gum is its slow rate of nicotine delivery and consequently slow onset of therapeutic effects. Previous research suggested that a nicotine hydrogen tartrate gum (NHTG1) that delivered nicotine more rapidly provided more effective craving relief. A subsequent gum formulation (NTHG2) was developed to further increase speed of delivery. Objective Compare the plasma nicotine absorption and clinical tolerability of NHTG2 to NHTG1 and Nicorette® FreshMint™. Methods A single-dose, randomized, crossover study evaluated the early kinetics of nicotine absorption and tolerability of 4 mg NHTG2 compared to NHTG1 and Nicorette. Results NHTG2 gum reached higher C max ( p = 0.059 versus Nicorette; p = 0.006 versus NHTG1) and delivered significantly more nicotine than Nicorette or NHTG1 within the first 10–30 min of chewing (AUCs 0–10, 0–30) and overall (AUC 0–180). NHT gums and Nicorette were well tolerated, with little difference in their AE profiles. Conclusions Study results indicate that NHTG2 gum provided more rapid uptake of nicotine in blood without notable decreases in tolerability. To the extent that rate of delivery and onset of therapeutic effects are related, these gums would be expected to provide more rapid therapeutic effects.
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