"Successful quitting for most smokers requires dealing with intense cravings for nicotine that arise in tempting situations," said Niaura, who helped design and conduct the study. "By relieving cravings quickly, rapid-release nicotine gum should decrease the chances of relapse and increase the chances of successful quitting. The sooner a person relieves cravings, the less the chance that they¡¦ll smoke in that situation." Sixty to ninety percent of smokers trying to quit relapse to smoking within the first year.
In a randomized, multi-center, open-label study designed to echo the real-world experiences of people quitting smoking, 319 smokers reported on the strength of their cravings before and after being exposed to a cigarette of their preferred brand, which they handled and lit without inhaling. Each smoker then chewed a piece of rapid-release gum or Nicorette for 30 minutes.
After three minutes, the first assessment post exposure to the cigarette, smokers chewing the rapid-release gum reported significantly lower cravings than those chewing Nicorette (p=.025). Smokers chewing rapid-release gum also reported more rapid meaningful relief and complete relief of their cravings.
In the study, 79% of participants chewing the rapid-release gum reported achieving meaningful relief after 12 minutes, compared to 69% of those on Nicorette (p=.05). By the end of 30 minutes of chewing, 92% of rapid-release gum chewers had achieved meaningful relief of craving, compared to only 77% of those on Nicorette (p=0.001). The difference in reports of meaningful relief was statistically significant at every timepoint from 12 to 35 minutes (p„T0.05). For complete relief, three times as many participants on rapid-release gum reported achieving complete relief than users of Nicorette even at the first time point (e.g., 12% vs. 4% at 3 minutes, p=.007).
The rapid-release gum releases nicotine more rapidly in the first few minutes compared to other nicotine gums, and continues to deliver a controlled, gradually reduced dose while it is chewed. To achieve this, the new gum relies on a novel gum base and buffer system, as well as on a different mechanism to bond the nicotine before it is released in the mouth, using a tartrate salt instead of the nicotine polacrilex used in currently available nicotine gums. The rapid-release gum is still in an experimental stage and has not been evaluated or approved by the U.S. Food and Drug Administration for marketing to smokers. The study was funded by Bayer Consumer Care.
Nicotine occurs naturally in tobacco. Smokers experience cravings for nicotine, and other physical withdrawal symptoms, when their blood levels of nicotine get too low. Replacing the nicotine from cigarettes with the nicotine in a therapy such as nicotine gum helps to relieve cravings experienced by smokers who are quitting.
"In the real world, people who quit smoking often find themselves in situations where they experience strong cravings," said Dr. Niaura. "The rapid-release gum was designed to deliver more nicotine in the first few minutes, when people need it most, and to continue to provide a smaller amount of nicotine over a longer period of time."
The rapid-release gum and accompanying technology were developed through collaboration between JSR, LLC and Biovail Corporation. Two U.S. patents have been issued covering the technology embodied in the new nicotine tartrate gum, and JSR, LLC and Biovail are working towards commercialization of this product.
JSR, LLC, is a Maryland limited liability corporation founded in 1998 to develop novel treatments for tobacco dependence.
Biovail Corp. (NYSE, TSX: BVF) is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.
Raymond Niaura, PhD, Director of Research at the Centers for Behavioral and Preventive Medicine, Brown Medical School/The Miriam Hospital served as a consultant on the study, assisting with its design and implementation. He and colleagues at the Centers for Behavioral and Preventive Medicine have conducted numerous studies on cue-provoked nicotine cravings. Niaura has no current affiliation with Bayer Consumer Care.