Pfizer Inc. (NYSE: PFE) shares slipped slightly on Friday after the pharma giant announced results from its Chantix/Champix (varenicline) smoking cessation study in adolescents. The Phase 4 data ultimately did not meet the primary endpoint in nicotine dependent adolescents between the ages of 12 and 19, compared to the placebo.
It’s worth pointing out that Chantix was previously approved by the U.S. Food and Drug Administration (FDA) back in May 2006 as a prescription medication to help adults quit smoking.
This study is a regulatory post-marketing commitment for Chantix/Champix in the United States and European Union for adolescents 12 to 16 years and 12 to 17 years of age, respectively.
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% of patients were nausea, headache, vomiting, agitation and abnormal dreams in the high-dose group, and nausea, dizziness, agitation, abnormal dreams and upper respiratory tract infection in the low-dose group.
James Rusnak, M.D., Ph.D., chief development officer, Internal Medicine, Pfizer, commented:
This study makes a valuable contribution to the limited body of clinical research on pharmacotherapy smoking cessation treatments for adolescent smokers. Chantix/Champix is an important treatment option for adults 18 and over who want to quit smoking.
Excluding Friday’s move, Pfizer has underperformed the U.S. broad markets over the past 52 weeks, with its stock up only 3%. In just 2018 alone, the stock is down nearly 2%.
Shares of Pfizer were last seen down 0.6% at $35.40, with a consensus analyst price target of $40.26 and a 52-week range of $31.67 to $39.43.