X-22 is a kit containing Very Low Nicotine (VLN) cigarettes that will go 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 expected delivery of nicotine. The therapy protocol allows the patient to smoke VLN cigarettes over a six-week treatment period to facilitate the goal of the patient quitting smoking following the treatment period.
Independent Studies Demonstrate VLN Cigarettes Increases Quit Rates
15 published clinical studies on Very Low Nicotine (VLN) cigarettes have demonstrated the product’s remarkable efficacy. Independent studies have shown increased quit rates, whether VLN cigarettes were used alone or concurrently with nicotine replacement therapy (NRT). Further, a Queen Mary University (London) Phase II trial showed that VLN cigarettes increase the efficacy of Pfizer’s best-selling Chantix® drug.
Highlights from a Ground-Breaking Independent Clinical Study
In the University of Minnesota Phase II trial (Hatsukami et al. 2010), 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. As an intent-to-treat clinical trial, subjects who dropped out were considered not abstinent or smoking.
The VLN cigarette was also associated with greater relief from withdrawal symptoms and craving 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 to FDA Approval
22nd Century is evaluating results and data from recently completed and on-going independent clinical trials that utilize the Company’s VLN cigarettes to determine which variables optimize smoking cessation. 22nd Century is currently identifying potential partners for the completion of the development and worldwide commercialization of X-22 as a prescription-based smoking cessation product.