FDA Approves Pfizer’s New Anti-smoking Pill by Jesse Madden Published: June 2006 Despite all of the anti-smoking campaigns and Surgeon General’s warnings, one in every five Americans smokes cigarettes. If you are one of them, chances are you’ve tried to stop smoking at least once. Of the 45 million who smoke, the Centers for Disease Control and Prevention (CDC) estimates that at least 32 million would like to quit. Unfortunately, as we all know, smoking is highly addictive and few smokers manage to quit without assistance. The brain’s addiction to nicotine is what makes quitting smoking so difficult. When you smoke, nicotine binds to the nicotinic receptors in your brain and causes stimulation in the pleasure centers of the brain. However, soon after the cigarette is finished, these effects diminish, causing cravings and withdrawal symptoms. With the approval of Pfizer’s new drug varenicline, marketed under the name Chantix®, it’s hoped that more people will have a chance to kick the habit for good. Chantix is the first nicotine-free drug in the last decade to win approval from the Food and Drug Administration for treating cigarette addiction, and the results from clinical trials are promising. In fact, the drug received priority review designation from the FDA because of its potential to be a significant advance over current nicotine addiction therapies. By activating the same nicotinic receptors in the brain, Chantix can mimic some of the stimulation normally caused by cigarettes, thus reducing the severity of the cravings and withdrawal symptoms that develop afterward. It also diminishes the sense of satisfaction a person feels if they do relapse and try to smoke while on the treatment. The approved course of Chantix treatment is 12 weeks. Before trying to quit smoking, patients begin on a dose of 0.5 milligrams (mg) a day for the first three days and then double the dosage to 1 mg for the remainder of the first week. On the first day they aim to not smoke, the dosage is increased to 2 mg per day for the remainder of the treatment course. Those patients who successfully quit smoking during the first 12 weeks of treatment may be prescribed an additional 12 weeks of Chantix treatment to further decrease their likelihood of relapse. In one European study, 22 percent of patients who were treated with Chantix were still smoke-free one year later – a six-percent increase over the only other nicotine-free drug for quitting smoking, Zyban®. But even Pfizer acknowledges that Chantix is not a silver bullet for those who want to quit. “It takes about 10 attempts, with or without treatment, before the average smoker is able to quit,” says Karen Katen, Pfizer vice chairman and president of Pfizer’s human health department. Chantix has not been approved for anyone under the age of 18. Patients are encouraged to select a date to quit smoking and begin treatment one week prior to stopping smoking. The most frequent side effect reported by patients has been nausea. Other side effects reported include gas, constipation, vomiting, insomnia, abnormal dreams and changes in taste perception. Patients who experience these side effects for any extended period of time should talk to their doctor about adjusting the dosage of the drug. Tobacco use is responsible for one in every five deaths annually in the United States. It is viewed as the single most preventable cause of death in this country. Of the 45 million Americans who smoke, nearly nine million have at least one smoking-related illness. “It is never too late to quit smoking,” says Dr. Cheryl Oncken, a Chantix clinical investigator and associate professor of medicine at the University of Connecticut Health Center. “People who quit smoking before the age of 50 have one-half the risk of dying of a smoking-related illness in the next 15 years compared to those who continue smoking.”

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