Stop Smoking Prescription

A Pfizer drug shown to help more than one in five smokers quit smoking has received federal approval on Thursday, adding another option to the limited number of effective stop-smoking prescription medicines.

Varenicline is the second drug without nicotine quit smoking to get approval from the FDA. Pfizer Inc. plans to market the tablet twice a day and stop smoking pill Chantix.

Varenicline works in two ways, by cutting the pleasure of smoking and reducing withdrawal symptoms that lead smokers to light cigarettes again.

Most other stop-smoking pills are various therapies for nicotine replacement, prescription and over the counter in gum, patch, lozenge, nasal spray or inhaler form. In 1997, the FDA approved bupropion, an antidepressant Wellbutrin already sold but it has changed the name Zyban, an anti-tobacco.

The course of treatment approved pill Chantix is 12 weeks, a period which can be doubled in patients who successfully quit to increase the likelihood they remain smoke-free, the Food and Drug Administration said.

Other clinical trials show the drug's effect is more pronounced in the short term: 44 percent of patients quit smoking after a course of 12 weeks of treatment with Chantix, against 30 per cent of patients who stop smoking Zyban , according to Pfizer. However, smoking cessation experts said the longer-term data are more applicable, given the difficulty to quit the habit for good.

"It will not be a revolution, it'll be a big step forward," Thomas Glynn, director of cancer science and trends at the American Cancer Society, said of varenicline. Glynn added that the greatest value will be for smokers who have tried Zyban or treatment of nicotine replacement, but not to quit.

"My bet is that it works as well as they do and the look of things a little better," he said.

Varenicline latches on the same receptors in the brain that nicotine inhalation of cigarette smoke, an action that causes the release of dopamine in the brain's pleasure centers. Taking the drug blocks any inhaled nicotine from reinforcing that effect.

The drug also slows the release of dopamine, which reduces the craving to smoke that occurs when nicotine's effect disappears, said Pfizer research chemist Jotham Coe, who invented the drug.

"He is a shield and at the same time, it stabilizes and prevents you from having the lowest, which lead to craving and withdrawal, but at the same time, it protects you from the highs," he said Coe, a former 2 1 / 2 a pack a day smoker, who quit once cold turkey and then a second time with the help of nicotine gum.

One in five adult Americans, or nearly 45 million people, smoke. It is estimated that 32 million of those smokers would like to quit smoking, according to the Centers for Disease Control and Prevention. Smoking kills nearly 440,000 Americans annually.

"Tobacco use, particularly cigarette smoking is the leading cause of preventable death in the United States and is responsible for a growing list of cancers and chronic diseases, including lung and heart," said Dr. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs.

Quitting smoking, as any smoker will tell you, is not easy. Less than one in 20 smokers can do so without help, "said Schroeder. With help, whether a drug, counseling or both, the success rate up to about one in five, "he added.