The biotechnology company 22nd Century Group said on Wednesday that an independent Phase II clinical trial that had explored the efficacy of its very low nicotine tobacco as a smoking cessation aid when combined with pharmacotherapy had been accepted for publication in Nicotine & Tobacco Research.
The study, which was conducted at Queen Mary University of London, was supported by a grant from the Global Research Awards for Nicotine Dependence funded by Pfizer.
‘The results of this study once again confirm the effectiveness of 22nd Century’s very low nicotine tobacco cigarettes as a smoking cessation aid,’ 22nd Century said in a press note issued through Business Wire. ‘The Company’s very low nicotine cigarettes satisfy the behavioral aspect of smoking while delivering only trace amounts of nicotine. Indeed, it is 22nd Century’s fundamental assertion that very low nicotine cigarettes uncouple the behavioral/sensory aspects of smoking from the rapid delivery of nicotine.
‘The Queen Mary researchers noted: “[Very low nicotine cigarettes] have been shown to be satisfying… [and] were also shown to reduce tobacco withdrawal symptoms, including urges to smoke and low mood”.’
The clinical trial compared the combination of very low nicotine cigarettes together with two other treatments: 1) varenicline (Pfizer’s Chantix), and 2) nicotine replacement therapies (patches, lozenges, etc.).
In each case, 22nd Century’s proprietary tobacco cigarettes were said to have provided smokers with a substantial boost in their efforts to stop smoking. ‘Despite providing patients with only a 2-week supply of 22nd Century’s very low nicotine cigarettes (a separately published Phase II clinical trial used a 6 week treatment period) researchers found that participants who received very low nicotine cigarettes had higher quit rates at 1-week, 4-weeks, 6-weeks, and at the study’s maximum 12-weeks,’ the press note said. ‘However, due to the size of the study, researchers were unable to achieve statistically significant results at 6 and 12 weeks.’
The Queen Mary study was said to have concluded that the most pragmatic approach might be to offer an ongoing supply of very low nicotine cigarettes to those who want to continue using them.
‘This conclusion echoes former US FDA commissioner Dr. David Kessler’s recommendation that “the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate harm reduction strategy.”’
22nd Century said it was ‘deeply committed’ to commercializing this approach and remained the only company in the world capable of producing virtually nicotine-free tobacco.