22nd Century reports results of Phase 3 study using SPECTRUM research cigarettes
22nd Century announced that Dr. Dorothy Hatsukami, at the Vermont Center on Behavior and Health's 5th Annual Conference on Tobacco Regulatory Science, revealed the fundamental findings of a highly anticipated 1,250-patient, 20-week study that compared smokers who were assigned to: i) an immediate reduction to Very Low Nicotine cigarettes; ii) gradual reduction in reduced nicotine content cigarettes; or iii) normal nicotine content cigarettes. Designed to determine which approach produces the most optimal outcomes for smokers, the announcement of the results of the seminal phase III study comes only weeks after the United States FDA announced that the Agency is exercising its authority under the Family Smoking Prevention and Tobacco Control Act to mandate lower nicotine - at non-addictive levels - in all combustible cigarettes sold in the United States. Though the details of Dr. Hatsukami's phase III study are still under peer review, Dr. Hatsukami divulged the answer to the study's core question of whether an immediate or a gradual reduction in nicotine is the best approach. Dr. Hatsukami clearly and confidently declared in her panel presentation at the Vermont Conference that "an immediate approach [to nicotine reduction] is most likely to lead to less harm." Further, Dr. Hatsukami pointed out that the study data indicates compensatory smoking is less likely to occur with an immediate reduction in nicotine, and that the there was a "greater likelihood of more rapid smoking cessation" with the immediate approach to nicotine reduction.