22nd Century Group, a company focused on the development of prescription smoking-cessation aids and tobacco harm reduction products, recently announced that the Food and Drug Administration (FDA) had cleared their new drug X-22 to begin Phase II clinical trials.
X-22 consists of very low nicotine (VLN) cigarettes made from 22nd Century’s proprietary tobacco.
The cigarettes contain 97% less nicotine than Marlboro Gold (formerly known as Marlboro Lights.) The therapy protocol of X-22 allows patients to smoke the X-22 cigarettes without restriction over a 6-week treatment period, to facilitate cessation, set to be achieved by the end of the sixth week. This year, the FDA approved X-22 as an Investigational New Drug (IND) and on July 21, cleared 22nd Century group to conduct Phase II-B clinical trials on the drug.
Before pharmaceutical companies start clinical trials on a drug and get them approved as INDs by the FDA, they must conduct extensive pre-clinical studies. Thereafter, if a drug successfully passes through Phases I, II, and III, it will usually be approved by the FDA for use in the general population. Phase IV and V are ‘post-approval’ studies usually involving side effects not observed prior to the release of the drug.
In a University of Minnesota Phase II-A trial, patients who used exclusively the X-22 achieved a 43% quit rate (confirmed four-week continuous abstinence) as compared to a quit rate of 35% and 21% for groups using other drugs. Smoking abstinence at the 6 week follow-up after the end of treatment was 47% for the X-22 cigarette group, and 37% and 23% respectively for the other drugs. If successful in gaining FDA approval, 22nd Century group plans to bring its X-22 cigarettes to the market as a prescription-only smoking cessation tool.
Industry documents released in May 2011 by Rodman & Renshaw seem to indicate that the genetically modified tobacco found in X-22 cigarettes does not contain any less tar or chemicals than that found in cigarettes dubbed as “light”. In fact, the report goes on to state that “the goal [of X-22] would be the prevention of nicotine addiction and a reduction in the prevalence of cigarette smoking, which in the long term would eliminate exposure to the toxins in tobacco smoke and reduce tobacco morbidity and mortality.”
Joseph Pandolfino, 22nd Century’s founder and CEO was quoted saying that “X-22 cigarettes smoke, taste and smell like typical cigarettes and have the potential to significantly increase smoking cessation by encouraging more smokers to attempt quitting with an acceptable and familiar product.” In other words, this company intends to market cigarettes with close to zero nicotine, which smokers get to smoke with no restriction in the hopes it weans them off nicotine, while inhaling the 4000+ chemicals, carcinogens and tar found in regular cigarettes: quit smoking with cigarettes that may just end up killing you. Brilliant!
Tags: electronic cigarettes