X-22

X-22 is a kit containing very low nicotine (VLN) cigarettes going through the FDA-approval process as a prescription smoking cessation aid.

22nd Century believes X-22 facilitates quitting by satisfying smokers’ cravings for cigarettes while (i) greatly reducing nicotine exposure and nicotine dependence and (ii) extinguishing the association between the act of smoking and the rapid delivery of nicotine. The therapy protocol allows the patient to smoke the Company’s VLN cigarettes ad libitum (as many cigarettes as desired) over the six-week treatment period to facilitate the goal of the patient quitting smoking by the end of the treatment period.

Independent Studies Demonstrate Efficacy

VLN cigarettes containing 22nd Century’s proprietary tobacco have been the subject of various independent studies, including two Phase II clinical trials for smoking cessation (Becker et al. 2008; Hatsukami et al. 2010).  In a University of Minnesota Phase II trial, patients exclusively using a VLN cigarette containing 22nd Century’s VLN proprietary tobacco achieved a 43% quit rate (confirmed four-week continuous abstinence) as compared to a quit rate of 35% for the group exclusively using a FDA-approved 4 mg nicotine lozenge (Commit®) and a 21% quit rate for the group exclusively using a low nicotine cigarette. Smoking abstinence at the 6 week follow-up after the end of treatment was 47% for the VLN cigarette group, 37% for the nicotine lozenge group and 23% for the low nicotine cigarette group. Carbon monoxide (CO) levels in patients were tested at each clinic visit to verify smoking abstinence.

The VLN cigarette was also associated with greater relief from withdrawal symptoms and cravings of usual brand cigarettes than the 4 mg nicotine lozenge. In fact, cravings continued to decline for weeks after treatment as shown here:

Clinical Pathway

The Company is conducting a Phase II-B trial in 2011 and plans to conduct two larger and concurrent Phase III trials in 2012. The FDA-approval process for its X-22 smoking cessation aid is expected to be completed by 22nd Century and upon such approval launch X-22 in the U.S. market in early 2013 (as a prescription), and in other top smoking cessation markets thereafter.  The Tobacco Control Act provides that products for smoking cessation, such as X-22, be considered for ‘‘Fast Track’’ designation by the FDA. The Fast Track programs of the FDA are intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. 22nd Century expects that X-22 will qualify for Fast Track designation.

References:

Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen J, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. 2010.
Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction 105:343-355.
http://www.ncbi.nlm.nih.gov/pubmed/20078491

Becker KM, Rose JE, Albino AP. 2008. A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation.
Nicotine Tob Res 10(7):1139-48.
http://www.ncbi.nlm.nih.gov/pubmed/18629723