I know alot of us around HofH are either entertaining the thought of quitting..in the process of..repeating the process again (practice makes perfect don't give up)..or have already quit.

 

For those who have managed to quit many kudo's to you..a hard won battle I'm sure.

 

A friend of mine called today and told me about a new pill called 'Varenicline,' it should be on the market soon. Pfizer submitted a New Drug Application this  month (Novemebr/2005), to the FDA for varenicline as well as European registration for smoking cessation. Inofr can be found in the last article of this post.

 

The claims by Pfizer's (substantiated ones at that)..are it helps us not only quit..but lose weight too. Hmm..yea I know I have my doubts too..cause we've all been disappointed before. Still it's at least worth looking into. So here are a few article's..if I hear more I'll post about it...and if anyone has any personal info on it let us know please.

 

Keep on keeping on..

Sha

 

 

NEW ORLEANS -- A new pill in the final stages of testing shows promise in attacking two of humanity's biggest killers by helping people quit smoking and lose weight at the same time.
 

As government officials in Washington launched a campaign against obesity Tuesday, doctors at a medical conference here described the new drug as provocative and perhaps ideal for some people.
 
The drug, which could be available in a year or two, works by an entirely new approach �?by blocking the same primeval circuitry in the brain that gives pot-smokers the munchies.
 
The development could offer a well-timed one-two punch against Americans' gravest health concerns. Smoking is the country's top killer and is rapidly being overtaken by obesity and inactivity. The two problems combined kill more than 800,000 Americans a year. A similar pattern is occurring worldwide, even in developing countries.
 
Doctors who heard data on the new pill said that while better living habits should still be the foundation of good health, a new pill could be an important boost for those who cannot accomplish it through willpower alone.
 
"We tell people to diet and exercise, and that advice doesn't seem to be very effective," said Dr. Raymond Gibbons of the Mayo Clinic, who called the latest results "very provocative."
 
Two reports on the drug, called rimonabant, were released in New Orleans at a meeting of the American College of Cardiology. The research was financed by the drug's developer, the French firm Sanofi-Synthelabo, which plans to seek U.S. approval to sell it under the brand Acomplia after more studies are finished next year.
 
One study found the drug helped people drop 20 pounds in a year, while the other concluded it doubles smokers' success at quitting, at least in the short run. Doctors said the drug is likely to be marketed both for dieting and smoking cessation, but it is likely to be especially appealing to people beset by both problems.
 
"We think this might be the ideal compound for people who are overweight and smoke," said Dr. Robert Anthenelli of the University of Cincinnati, who directed the smoking study.
 
Doctors say the drug is also noteworthy because it takes a fresh approach to helping people overcome their yen for food and tobacco. It is the first of a class of medicines that block the so-called endocannabinoid system.
 
Marijuana makes people ravenous by stimulating this circuitry. The same biological machinery serves crucial everyday purposes by helping the brain regulate hunger and probably other urges, including alcohol craving.
 
Overeating and smoking can overstimulate this system, which in turn propels them to eat and smoke still more. By temporarily blocking the body's ability to receive these signals, experts believe they can return the system's working to normal.
 
In the larger of the two studies, Dr. Jean-Pierre Despres of Laval University in Quebec City enrolled 1,036 overweight volunteers, all with big potbellies that put them at especially high risk of heart problems. They were urged to cut 600 calories a day and randomly given either rimonabant or dummy pills.
 
After a year, those who got the higher of two doses of rimonabant had lost an average of 20 pounds and trimmed three inches from their waistlines. Nearly half of them took off 10 percent of their body weight. By comparison, those on placebos lost just five pounds.
 
Those getting rimonabant improved in other ways, too. Their levels of HDL, the protective good cholesterol, rose 23 percent, while their triglycerides fell 15 percent.
 
Despres said people taking the drug simply felt less hungry. In an earlier phase of the research, he could tell which volunteers were on the medicine by watching who passed up chocolate cake at the buffet table.
 
"The bottom line is we found a spectacular drop in waistlines and changes in many other risk factors that are beyond what you would ordinarily expect," Despres said.
 
Anthenelli's study tested the drug for 10 weeks on 787 pack-a-day smokers who wanted to quit but could not. A longer follow-up will see how well they stay off, but in the short run, 28 percent shunned cigarettes for at least a month, compared with 16 percent on dummy pills.
 
Especially important, Anthenelli said, is that those on the drug gained little or no weight, and a third of the successful quitters actually took off pounds at the same time. Ordinarily, smokers gain six to 10 pounds when they quit.
 
Some people had minor digestive side effects at first, but they usually went away.
 
"This is good news. The drug shows promise," said Dr. Sidney Smith, cardiovascular chief at the University of North Carolina. "However, I strongly believe lifestyle changes should be the foundation of what we do. I would not want to see patients turn to a pill as the first approach."
 
In all, seven large studies with rimonabant are in the works. They involve 6,600 volunteers who want to lose weight and 6,500 who want to quit smoking.

 

Source:

 

and a newer article:

 

Associated Press
Mar. 8, 2005 06:35 AM

 

GROTON, Conn. - Researchers are racing to develop a potentially lucrative drug that would make smoking as treatable as erectile dysfunction, high cholesterol and acid reflux disease.

Major pharmaceutical companies and small startups see the potential for billions of dollars in sales for a vaccine or a nicotine-free pill that could end addiction at the chemical level for America's 50 million smokers.

"It's the biggest addiction market there is," said Dr. Herbert D. Kleber, a psychiatry professor and addiction researcher at Columbia University. "Is it realistic to be able to help addicts stop smoking and remain off with a pill? I think the answer is yes and we're working on a number of them."
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While nicotine patches, gums, lozenges and sprays help wean smokers off cigarettes by slowly reducing their dependence on nicotine, researchers are tailoring drugs to mimic or block nicotine's chemical reactions with the body.

In Connecticut, researchers at Pfizer Inc. identified a brain receptor that nicotine binds to and designed a drug, varenicline, that latches to the same site. Varenicline is in Phase III testing, normally the last step before a company applies for approval from the Food and Drug Administration.

Researchers hope that the drug will attach to nicotine receptors in the brain, preventing overpowering cravings from setting in when someone stops smoking.

If varenicline's claims hold up, the drug could generate more than $500 million a year in sales, said David Moskowitz, an analyst with Friedman, Billings, Ramsey & Co.

"It's an unmet medical need," said Dr. Karen Reeves, executive director of clinical development for Pfizer. "The morbidity and mortality rate is so high, and doctors and smokers really have not had enough in their armamentarium to help smokers stop smoking."

The French pharmaceutical company Sanofi-Synthelabo said it will ask for FDA approval this year for the drug rimonabant, which it would market under the name Acomplia as a way to help stop smoking and overeating.

Acomplia targets circuitry in the brain that encourages smokers to keep lighting up. If the body's chemical reward system is blocked, smoking might not be as pleasurable or as addictive.

Researchers have high hopes for the drug, saying it might also treat alcohol and drug abuse.

That combination could translate into billions in yearly sales, Moskowitz said.

Then there's NicVax, a drug that Florida-based Nabi Pharmaceuticals claims could be used as a nicotine vaccine. NicVax triggers the production of antibodies that bind to nicotine molecules, preventing them from reacting with receptors in the brain.

NicVax, which was developed primarily with grants from the National Institute on Drug Abuse, has shown promise in early trials and could begin Phase III testing late this year, the company said.

A similar drug, called Ta-Nic, is in early testing by the Xenova Group in England.

"Everyone has been looking for the magic bullet," said Thomas Glynn, director of cancer science and trends for the American Cancer Society.

Whether one will be found remains uncertain, he said. It's more likely, doctors agree, that scientists will develop a number of successful drugs that will prove effective, but no single pill will "cure" smoking.

Doctors with high hopes have been let down before. In 1997, the FDA approved bupropion, commonly sold under the name Zyban, as an anti-smoking drug.

The drug, which was originally marketed as an antidepressant, has proven successful for some smokers but was never the industry blockbuster some expected.

Dr. Cheryl Oncken, associate professor of medicine at the University of Connecticut Health Center, said the new drugs being developed represent the next generation of medicine. Oncken will present a research study this weekend on varenicline, which in an earlier Pfizer study was shown to help nearly half of smokers quit within seven weeks - compared to about 33 percent with bupropion.

Investors are proceeding cautiously. Scott Henry, a Pfizer analyst at Oppenheimer & Co., said it's too early to tell whether there is a smoking wonder drug in development. He said varenicline has shown promise, but like all drugs being tested, there are many unanswered questions.

"Is it truly a revolutionary new treatment, or is just another bell and whistle?" he said.

Source:

 

Press Release Source: Pfizer Inc 

New Data: Pfizer's Varenicline is an Effective and Safe Treatment for Smoking Cessation
Tuesday November 15, 9:00 am ET
Odds of Quitting Doubled on Varenicline as Compared to Current Leading Prescription Medication

DALLAS, Nov. 15 /PRNewswire-FirstCall/ -- Pfizer Inc's smoking cessation medicine varenicline tartrate was shown to be more effective than the only marketed oral prescription anti-smoking medicine, according to data presented here today at the annual meeting of the American Heart Association. Upon approval, Pfizer intends to market varenicline under the brand name Champix®.

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Discovered and developed by Pfizer, varenicline is a selective nicotinic acetylcholine receptor partial agonist, the first in a new class of potential smoking cessation therapies.

In two double-blind placebo-controlled studies involving about 2,000 smokers, patients received either varenicline (1 mg twice daily), bupropion, marketed as Zyban (150 mg twice daily), or placebo for 12 weeks. Patients were followed for an additional 40 weeks without treatment.

In both studies, 44 percent of varenicline-treated patients quit by the end of the 12-week treatment period, significantly more than the 30 percent of Zyban patients who quit. Among patients who received placebo, 18 percent had quit by the end of the 12-week treatment period. The odds of quitting smoking for patients taking varenicline were approximately two times higher than those on bupropion, and four times higher than those on placebo.

After one year, patients who received varenicline were significantly more likely to remain smoke-free compared to patients who received bupropion or placebo.

"These results are very encouraging," said Dr. Serena Tonstad, head physician, Department of Preventive Cardiology, Ulleval University Hospital, Norway. "Smoking doubles a person's risk of cardiovascular disease and triples the risk of death from heart attack. Patients who are serious about quitting should seek medical support and treatment to help them ultimately succeed."

A third study randomized smokers who successfully quit smoking after 12 weeks of varenicline to 12 weeks of either placebo or an additional 12 weeks of varenicline. These patients were followed for 28 weeks after the treatment period.

There were significant benefits observed among patients who received additional treatment after successfully quitting on varenicline. Seventy-one percent of patients who received the additional course of varenicline remained abstinent after six months, compared to 50 percent who received placebo as the second course.

Smoking is the leading preventable cause of illness and premature death in the United States. Each year, smoking is responsible for 140,000 deaths from cardiovascular disease by increasing the risk of heart attack, stroke and sudden death. Annual health-related costs in the United States are estimated to be $167 billion.

Smoking is a chronic relapsing condition that involves a physical and psychological addiction to nicotine. When a smoker inhales a cigarette, nicotine reaches the brain in less than 10 seconds. The nicotine binds to receptors, leading to the release of dopamine in the pleasure centers of the brain. As nicotine levels drop, satisfaction recedes quickly, resulting in craving and withdrawal symptoms such as irritability and anxiety. This, in turn, leads to continued smoking behavior.

"Varenicline was specifically designed to work at the same receptor site as nicotine to relieve craving and withdrawal symptoms while at the same time blocking the reinforcing effects of nicotine," said Dr. Salomon Azoulay, varenicline development lead at Pfizer.

In all trials, varenicline was well tolerated, with overall discontinuation rates similar to placebo. The most common side effects included nausea, headache, trouble sleeping and abnormal dreams.

This month Pfizer submitted a New Drug Application to the FDA for varenicline as well as European registration for smoking cessation.

 

 

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