The US Food and Drug Administration will give a priority review to drug giant Pfizer’s anti-smoking drug Champix (varenicline tartrate), thereby chopping the usual 10-12 month review period to just six months.
But this does not mean that the agency will reach a decision within six months from now, as the Champix filing will only move forward once the FDA formally determines the application is sufficiently complete for review, the group noted.
Pfizer has high hopes for the drug, which, in all clinical trials to date, has been well-tolerated with overall smoking discontinuation rates similar to placebo. The first non-nicotinic drug specifically developed for use in smoking cessation, Champix eases the symptoms of smoking withdrawal by activating the same brain receptor stimulated by nicotine from a cigarette, which is responsible for that powerful sense of satisfaction smoking a cigarette can trigger.
The need for an effective drug to help smokers kick their habit is greater than ever. According to World Health Organization figures, every eight seconds a person dies of a smoking-related disease, and less than 7% who try to quit on their own manage to abstain for more than one year, with most relapsing after just a few days.
A particularly bleak picture was painted by Hank McKinnell, Pfizer’s Chairman and Chief Executive Officer, who warned: “If current smoking patterns continue, the annual number of people dying of smoking-related diseases globally will double from five to 10 million deaths by 2020.”
And on the economic side, “In the United States alone, the cost of treating smoking-related diseases is an estimated $150 billion a year,” said Karen Katen, Vice Chairman and President of Pfizer Human Health. “The priority review designation for Champix underscores the significant patient need for new therapies that will reduce the health burden of smoking,” she added.
If approved, Champix will compete with GlaxoSmithKline’s Zyban (buproprion), which has been dogged with safety concerns since its launch in 2000. Moreover, recent late-stage trials, presented at the American Heart Association annual meeting in Dallas, showed that smokers taking Pfizer’s drug doubled their chances of quitting compared to those taking Zyban, indicating that it could well become the leader in the market.