A clinical study involving Pfizer, Inc.’s (NYSE:PFE) Chantix was a success, the company announced Tuesday. The study, which assessed the efficacy and safety of the drug, also known as varenicline, met its primary and secondary endpoints, according to Business Wire.
The study is the first involving varenicline to approach the goal of smoking-cessation by first reducing smoking prior to patients quitting outright. The trial addressed in particular smokers who were either unwilling or unable to quit smoking within four weeks, but had agreed to reduce the amount they smoked over a 12 week period with the goal of eventually quitting by the end of that period.
Smoking reduction prior to cessation is now a common approach to treatment, as many smokers find a fixed “quit date” intimidating, according to Stephen J. Romano, M.D., who works for Pfizer as Senior vice president and Head of the Medicines Development Group. Smokers in the Chantix trial were treated for both a 12-week reduction phase followed by a 12-week abstinence phase, for a total of 24 weeks of treatment. “This study was designed with this quitting approach in mind,” Romano continued.
The drug was first approved by the FDA in 2006 as an aid to smoking-cessation treatment for adults 18 and older. As part of the study, participants were randomized to either 1mg of varenicline twice daily, or a placebo, for 24 weeks, followed by a 28 day non-treatment phase. All of the participants were provided with brief smoking cessation counseling, and preliminary results have indicated that Chantix was more significantly more effective than the placebo in helping smokers in the study quit. Further, findings regarding the safety of varenicline were consistent with previous findings, per Business Wire.
Pfizer has seen revenue drops in the past few quarters due to increasing competition from generic drugs; many of its top-selling products now have generic alternatives. The company has also seen recent difficulties in China, where it was called out by that country’s equivalent of the Food and Drug Administration. Pfizer appears to be recovering slowly, however, as it enters a number of late-stage clinical trials for a number of experimental drugs, according to the Wall Street Journal.