Pfizer announced new findings from a Phase 4 study evaluating the safety and efficacy of Chantix (varenicline) for smoking cessation in nicotine dependent adolescents aged 12–19 years. Chantix, a nicotinic receptor partial agonist, is currently approved as a smoking cessation aid for adults.
The randomized, double-blind, placebo-controlled, parallel-group, dose-ranging multicenter postmarketing study evaluated Chantix with age-appropriate counseling for smoking cessation in nicotine dependent adolescents (N=312). After a 2-week titration, those in the varenicline group weighing >55kg received varenicline 1mg twice daily (high-dose group) or 0.5mg twice daily (low-dose group). Patients weighing ≤55kg received 0.5mg twice daily (high-dose group) or 0.5mg once daily (low-dose group). Study participants received treatment for 12 weeks followed by a 40-week non-treatment period.
Results showed that the study did not meet its primary endpoint of 4-week continuous abstinence rate (Weeks 9–12) for Chantix when compared to placebo. Adverse events observed among adolescent smokers in the study were comparable to those seen in adult studies.
Full study data will be submitted for presentation at an upcoming scientific congress and for publication. The data will also be submitted to the Food and Drug Administration (FDA) for pediatric exclusivity determination.
For more information call (800) 438-1985 or visit Chantix.com.