Chantix Labeling Updated Following Pediatric Smoking Cessation Study

Results from a placebo-controlled study evaluating Chantix (varenicline; Pfizer) in pediatric patients 12-16 years of age showed that the smoking cessation treatment was not associated with a significant increase in abstinence rates in this patient population.

Due to these findings, the labeling for Chantix has been updated to specify that the drug is not recommended for use in pediatric patients 16 years of age or younger. Moreover, the efficacy of Chantix in patients 17-19 years of age could not be determined as the study was not powered to evaluate this age group, although these young adults were permitted to participate in the study.

Chantix, a nicotinic receptor partial agonist, is currently indicated for use as an aid to smoking cessation treatment in adults. The efficacy of Chantix in smoking cessation is believed to be the result of activity at the α4β2 subtype of the nicotinic receptor where its binding produces agonist activity, while simultaneously preventing nicotine binding to these receptors.

According to the Food and Drug Administration (FDA), Pfizer was required to conduct the pediatric trial under the Pediatric Research Equity Act. Commenting on the study results, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research said, “Today’s labeling changes for [Chantix] intended to help adult smokers quit cigarettes underscores the finding that current drug therapies for smoking cessation that work for adults may not be effective and appropriate for youth.” Woodcock went on to say that the Agency is committed to finding additional treatment strategies, both pharmacological and behavioral interventions, to support youth cessation of tobacco products.

For more information visit FDA.gov.