FDA Approves Varenicline for Smoking Cessation

Sat, 20 May 2006 02:52:37 PST

( from http://www.rxpgnews.com ) The U.S. Food and Drug Administration (FDA) announced today the approval of Chantix (varenicline tartrate) tablets, to help cigarette smokers stop smoking. The active ingredient in Chantix, varenicline tartrate, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health.

Chantix acts at sites in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking.

"Tobacco use, particularly cigarette smoking, is the single most preventable cause of death in the United States and is responsible for a growing list of cancers as well as chronic diseases including those of the lung and heart," said Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs. "The agency is committed to helping facilitate the development of products to help people quit smoking and improve their overall quality of life."

According to the Centers for Disease Control and Prevention (CDC), an estimated 44.5 million adults in the United States smoke cigarettes and more than 8.6 million of them have at least one serious illness caused by smoking.

"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction" said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "Chantix therapy has proven to be effective in smokers motivated to quit and will provide another tool for physicians to use for the millions of smokers who want to quit."

The effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3659 chronic cigarette smokers who were treated with varenicline. Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smoking. These smokers had previously averaged 21 cigarettes a day for approximately 25 years. In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban (bupropion).

The approved course of Chantix treatment is 12 weeks. Patients who successfully quit smoking during Chantix treatment may continue with an additional 12 weeks of Chantix treatment to further increase the likelihood of long-term smoking cessation.

In clinical trials, the most common adverse effects of Chantix were nausea, headache, vomiting, flatulence (gas), insomnia, abnormal dreams, and dysgeusia (change in taste perception).

Chantix is manufactured and distributed by Pfizer, Inc., New York, NY.

Varenicline could increase number who quit smoking

Sun, 07 May 2006 19:52:37 PST

( from http://www.rxpgnews.com ) Smokers who try to quit using existing medications, such as nicotine patches or Zyban, are about twice as likely to succeed as those who don't use medication or are prescribed placebos during clinical trials.

But despite the relative effectiveness of medications currently on the market, more than 80 per cent of quitters will be smoking again within a year, according to a review in the latest IJCP, the UK-based International Journal of Clinical Practice.

A new kind of drug has now been developed that could improve long-term quit rates, according to Dr Jonathan Foulds from the Tobacco Dependence Program at the University of Medicine and Dentistry of New Jersey.

Varenicline is being evaluated by the US Food and Drug Administration under a six-month priority review which began in late 2005.

"Trials carried out so far have yielded promising results, suggesting that varenicline could be a major advance in the treatment of nicotine dependence" says Dr Foulds.

"Drugs are normally earmarked for priority review by the FDA if they are felt to address health needs that are not currently being adequately met.

"What makes varenicline different to existing medication is that it is the first treatment specifically designed to target the neurobiological mechanism of nicotine dependence."

Initial results show that the drug successfully stimulates dopamine sometimes called the brain's pleasure chemical as well as blocking nicotine receptors. This reduces nicotine withdrawal symptoms and craving and may also prevent a lapse from turning into a full relapse.

Existing quit smoking methods have limited success and studies have found that some 18 per cent of people using them will be smoke free after a year, compared with 10 per cent of people prescribed placebos.

This figure can be increased to 25 to 35 per cent when smokers receive intensive counselling and combined medications are used.

Dr Foulds summarised 141 studies covering just over 48,000 subjects who were randomly allocated different types of medication or placebos.

He found that quit rates with nicotine replacement methods and drugs such as bupropion (trade name Zyban), nortriptyline and clonidine ranged from 14.6 per cent to 24.9 per cent. Smokers who were prescribed placebos (dummy drugs) achieved success rate of between 8.6 per cent and 14.4 per cent.

But clinical trials carried out with varenicline on thousands of smokers suggest that the new drug yield may yield better success rates.

The results of human trials reported in 2005 and 2006 found that short and long-term quit rates were higher when compared with placebos or bupropion (Zyban).

Studies presented at recent scientific meetings have shown that short-term quit rates in the first 12 weeks were approximately four times higher with varenicline than placebos and that long-term abstinence rates, for the first year, were more than twice those of placebos.

"Almost 20 countries and numerous US states have already announced or implemented comprehensive indoor smoking bans and that figure is rising all the time" adds Dr Foulds.

"Here in New Jersey, for example, smoking is very expensive and we have just implemented comprehensive legislation to ban smoking indoors in virtually all pubic places.

"This is good news for smokers and non smokers alike as many smokers are keen to quit and this gives them an added incentive.

"Medicines like varenicline are very important as they will help many more people to quit smoking, including those who have failed with other methods."

RxPG News : Varenicline

FDA Approves Varenicline for Smoking Cessation

Varenicline could increase number who quit smoking