Pfizer Reports Top-Line Results from a Study of CHANTIX/CHAMPIX (varenicline) in Adolescent Smokers
Pfizer Inc. announced results from a Phase 4 study evaluating the efficacy and safety of CHANTIX/CHAMPIX (varenicline) for smoking cessation in nicotine dependent adolescents 12-19 years of age. The study did not meet its primary endpoint of the four-week continuous abstinence rate at weeks 9 through 12 for CHANTIX/CHAMPIX compared to placebo. The study is a regulatory post marketing commitment for CHANTIX/CHAMPIX in the U.S. and EU for adolescents 12-16 years and 12-17 years of age, respectively.
“This study makes a valuable contribution to the limited body of clinical research on pharmacotherapy smoking cessation treatments for adolescent smokers,” said James Rusnak, M.D., Ph.D., Chief Development Officer, Internal Medicine, Pfizer Inc. “CHANTIX/CHAMPIX is an important treatment option for adults 18 and over who want to quit smoking.”
The adverse event profile of CHANTIX/CHAMPIX observed in this study of adolescent smokers was similar to that seen in studies of adults. The most common adverse events that occurred in at least 5 percent of patients were nausea, headache, vomiting, agitation, and abnormal dreams (high dose group); and nausea, dizziness, agitation, abnormal dreams, and upper respiratory tract infection (low dose group).