More positive data for Pfizer’s Chantix

The drug was also shown to be effective with a favorable safety profile in three pivotal studies published in the Journal of the American Medical Association.

Data show that approximately 44% of patients treated with a 1mg dose of Chantix twice a day quit smoking by the end of the 12-week treatment period versus 30% who used 150mg Zyban (buproprion SR) twice a day and 18% who used placebo.

In an additional phase III clinical trial, patients who quit after 12 weeks of treatment with Chantix were randomized to receive an additional 12 weeks of treatment with Chantix or placebo. At the end of 24 weeks, 70.5% of patients on Chantix continued to abstain from smoking compared to 50% who switched to placebo.

In trials, Chantix was generally well tolerated with overall discontinuation rates similar to placebo. The most frequent side effects included nausea, headache, trouble sleeping and changes in dreaming.

Chantix, the first new prescription smoking cessation medication approved in nearly a decade, received FDA approval on May 10, 2006 and is expected to be available in US pharmacies in August. In November 2005, Pfizer also submitted a European marketing authorization application for the drug in smoking cessation.

The company also said that Chantix will be available to patients with a support program designed to help address behavioral components of smoking dependence.

“According to the World Health Organization, every eight seconds a person dies of a smoking-related disease – almost as quickly as someone else takes up smoking for the first time,” said Dr Joseph Feczko, Pfizer’s chief medical officer. “Chantix represents a significant new discovery for smokers who are trying to quit.”