• Christelle Haziza, Guillaume de La Bourdonnaye, Dimitra Skiada, Jacek Ancerewicz, Gizelle Baker, Patrick Picavet, and Frank Lüdicke.
• PMI R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland. Electronic address: Christelle.Haziza@pmi.com.
• Regul. Toxicol. Pharmacol. 2016 Nov 30; 81 Suppl 2: S139-S150.

AbstractThe Tobacco Heating System (THS) 2.2, a candidate Modified Risk Tobacco Product (MRTP), is designed to heat tobacco without burning it. Tobacco is heated in order to reduce the formation of harmful and potentially harmful constituents (HPHC), and reduce the consequent exposure, compared with combustible cigarettes (CC). In this 5-day exposure, controlled, parallel-group, open-label clinical study, 160 smoking, healthy subjects were randomized to three groups and asked to: (1) switch from CCs to THS 2.2 (THS group; 80 participants); (2) continue to use their own non-menthol CC brand (CC group; 41 participants); or (3) to refrain from smoking (smoking abstinence (SA) group; 39 participants). Biomarkers of exposure, except those associated with nicotine exposure, were significantly reduced in the THS group compared with the CC group, and approached the levels observed in the SA group. Increased product consumption and total puff volume were reported in the THS group. However, exposure to nicotine was similar to CC at the end of the confinement period. Reduction in urge-to-smoke was comparable between the THS and CC groups and THS 2.2 product was well tolerated.Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

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