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TSRC, Tob. Sci. Res. Conf., 2015, 69, abstr. 41

A novel nicotine sublingual tablet which mimics cigarette smoking nicotine pharmacokinetics

McCARTY J.(1); VOCCI F.J.(2); TORRINGTON M.(2)
(1) IntraTab Labs Inc, Miami, FL USA; (2) Friends Research Institute Inc., Baltimore, MD USA

Very little by way of new nicotine products have been introduced into the market, despite scientists’ and clinicians’ pleas specifically for a faster-acting product that resembles nicotine pharmacokinetics as produced by cigarette smoking. Pharmacokinetic (PK) data obtained from a novel nicotine sublingual tablet demonstrates that such a product has now been developed. Our novel nicotine tablet uses a patented drug delivery technology that enables very rapid, accurate and repeatable delivery of drugs transmucosally from a small tablet placed sublingually in the mouth. A pharmacokinetic study compared the novel nicotine tablet to the same strength nicotine lozenge in an open-label, randomized, crossover design in 6 healthy, heavily-dependent smokers participating in both arms of the trial. The outcomes measured were time to maximum nicotine plasma concentration (Tmax), maximum plasma concentration (Cmax) and the area under the nicotine plasma curve (AUC) which was compared between the novel nicotine tablet and the lozenge. The novel nicotine sublingual tablet had rapid absorption into the plasma with a median Tmax = 17 minutes as compared to 84 minutes for the nicotine lozenge. The mean Cmax values between the treatment groups were not statistically different having a p-value of 0.56. The mean AUC0-180 values were statistically different with a p-value 0.03 with the lozenge having greater exposure. This novel sublingual tablet promises to provide the smoker with a real unmet medical need for a safe, convenient, inexpensive nicotine replacement therapy that mimics nicotine pharmacokinetics obtained from cigarette smoking. This pilot PK study was funded by NIH through a Phase I STTR NIDA Grant (1R41DA033710-01A1).