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Home>Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine is Most Likely to Lead to Less Harm

Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine is Most Likely to Lead to Less Harm

Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine is Most Likely to Lead to Less Harm

10/06/2017

Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine is Most Likely to Lead to Less Harm

“Minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy”

22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today 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 Food and Drug Administration (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.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171006005223/en/

22nd Century’s proprietary SPECTRUM® research cigarettes facilitate independent studies on nicotine ...

22nd Century’s proprietary SPECTRUM® research cigarettes facilitate independent studies on nicotine reduction strategies. The FDA plans to mandate lower nicotine – at non-addictive levels – in all cigarettes sold in the United States. (Photo: Business Wire)

Dr. Hatsukami, who is the Co-Director of the Center for the Evaluation of Nicotine in Cigarettes and Professor of Psychiatry and Director of the Tobacco Research Programs at the University of Minnesota, led the ground-breaking phase III study that was conducted in 10 cities across the United States and included participants from all demographics.

22nd Century was the exclusive provider of the Very Low Nicotine and other SPECTRUM research cigarettes that were used in Dr. Hatsukami’s 1,250-participant trial and in more than 16 other clinical trials. In fact, 22nd Century is the only company in the world capable of growing tobacco with nicotine levels of just 0.4mg per gram of tobacco, which is more than a 95% reduction in nicotine as compared to tobacco in conventional cigarettes. Many scientists around the world believe that tobacco with this very low level of nicotine is minimally or non-addictive.

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.

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