Personal smoking cessation therapy combines optimized nicotine delivery, personalized behavioral support and monitoring, and compliance.
Chrono Therapeutics announced that clinical data for the company's smoking cessation technology showed a statistically significant reduction in nicotine cravings in a trial of adult male smokers. The data were presented at the Society for Research on Nicotine & Tobacco's 22nd Annual Meeting.
Chrono's wearable transdermal drug delivery device times nicotine delivery to when smokers have their strongest cravings. For example, 75 percent of all smokers reach for their first cigarette within 30 minutes of waking up. The Chrono Solution is designed to deliver the first dose of nicotine replacement therapy (NRT) shortly before a smoker wakes up and then creates a pattern of "peaks and troughs" of nicotine delivery throughout the rest of the day to assure the smoker has more nicotine support when cravings are predicted to be strongest.
"In the United States, 70 percent of smokers want to quit, but quitting is extremely difficult. In fact, most people try 8 to 10 times and this includes quit attempts with standard cessation medications like nicotine patch and gum and prescription drugs like varenicline," said Alan Levy, Ph.D., chairman and CEO of Chrono Therapeutics. "Gums and patches are designed to help manage cravings, but they are only 5 to 9 percent effective. Our goal is to solve this crisis of public health with an innovative, integrated smoking cessation solution, and the data we presented demonstrates that we are on the right path."
The clinical trial was a randomized, double blinded study of 24 adult males who smoked 11 or more cigarettes per day, indicating a high level of nicotine dependence. The subjects were divided into two groups. Test group subjects had nicotine administered over a 30-hour time period via Chrono's prototype device that delivered nicotine according to Chrono's "peaks and troughs" profile. Control subjects had a placebo solution, with no nicotine, administered at the same intervals via the same prototype device. Across both groups, subjects showed no serious adverse events or study withdrawals due to an adverse event. Skin irritation assessment showed no signs of irritation or erythema.
Cravings were assessed via three different methods: the Questionnaire for Smoking Urges (QSU), the Mood and Physical Symptoms Scale (MPSS) and a single craving question, each of which is a validated tool to assess cravings. When compared to subjects treated with placebo, test subjects had a statistically significant and clinically meaningful reduction in cravings for all assessment methods (p=0.035; p=0.034, and p=0.016, respectively).
"Achieving statistical significance in a 24-subject trial is very striking and happens infrequently in biopharma; so these results are very encouraging," noted Wende Hutton, general partner at Canaan Partners and a member of Chrono's board of directors. "Quitting smoking is one of the simplest ways to improve global public health, but as the dismal efficacy of current therapies demonstrates, it is also one of the hardest. I'm very excited to be working with a company that has the potential to solve such a serious problem."