Positive Clinical Study Results for Pfizer’s Chantix
Pfizer announced yesterday that Chantix/Champix (varenicline) has been shown to help smokers unable to quit ‘cold turkey’ kick their habit by slowly reducing the amount of cigarettes they smoke.
The initial clinical study to assess the drug demonstrated that Chantix/Champix helped improve abstinence rates, in people wanting to reduce smoking prior to quitting.
In the clinical trial, patients were randomised to receive either Chantix/Champix or placebo for 24 weeks of treatment, followed by a 28-week non-treatment phase.
The inclusion criteria for the trial allowed for enrolment of smokers with certain psychiatric diagnoses, with appropriate monitoring throughout the clinical study.
The results of the trial showed continuous abstinence rates at weeks 15 through 24 (the primary endpoint) were considerably higher in the treatment arm (32.1%) than the placebo group (6.9%), demonstrating the Chantix’s potential in this approach to quitting smoking.
In addition, Pfizer confirmed that they were no new safety signals raised in the study, with tolerability being roughly the same as previous clinical studies.
Compared to the control arm, the most commonly reported side effects in patients taking Chantix/Champix were nausea (27.8% versus 9%), nasopharyngitis (13% versus 12%), abnormal dreams (11.5% vs 5.8%) and insomnia (10.7% vs. 6.9%).
The drug was approved by the US FDA in May 2006, but recently sales have dropped, with fourth-quarter 2013 sales down at $174 million.