• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Scientists Enthusiastic About New Weight-Loss Drug ; Pill May Also Help Smokers Kick the Habit, Officials Say

Posted on: Wednesday, 10 November 2004, 18:00 CST

NEW ORLEANS - An experimental pill made by Sanofi Aventis SA that offers the fairy-tale promise of helping people lose weight and quit smoking has gathered even more stardust.

The biggest test yet of the drug found that it helped people not only drop pounds but also keep them off for two years longer than any other diet drug has been able to achieve. Cholesterol and other health measures improved, too.

The impressive results from a study of more than 3,000 obese people were presented at a medical conference Tuesday, capping months of anticipation about the French pharmaceutical giant's new drug, Acomplia.

Doctors called the research exciting and Sanofi Aventis, which funded the study, thinks the drug could have blockbuster potential similar to cholesterol-lowering statin drugs.

Wall Street appears to agree. Morgan Stanley recently estimated Acomplia could achieve revenues of roughly $1 billion in 2010. In another report, J.P. Morgan Securities calls the drug "fundamental" to Sanofi Aventis' long-term growth.

In a study of 3,040 obese people throughout the United States and Canada, those given the higher of two doses of Acomplia lost more than 5 percent of their initial body weight, and a third of them lost more than 10 percent.

"They achieved and maintained a weight loss of 19 pounds as compared to 5.1 pounds in the placebo group," said Dr. F. Xavier Pi- Sunyer of Columbia University in New York, who led the research and presented results at the American Heart Association conference.

About two-thirds of American adults are overweight or obese, raising their risk of everything from cancer and cardiovascular disease to sore joints and snoring. About a fourth of American adults smoke, which brings many of the same woes.

It's been devilishly difficult to develop effective treatments for either problem. Diet drugs in particular have a checkered history, most notably the withdrawal from the market in 1997 of the popular "fen-phen" drug combination after users developed heart valve problems.

Drugs now on the market either are designed for short-term use or have distasteful side effects like bowel problems that make many shy away from them.

Sanofi Aventis thinks Acomplia will avoid those problems by attacking obesity in a novel way, and plans to seek federal approval for it next year.

It's the first diet drug aimed at blocking the "pleasure center" of the brain and interfering with the cycle of craving and satisfaction that drives many compulsive behaviors and addictions. This same circuitry is activated when people smoke pot.

"What we have here now is essentially a brand new mechanism to treat an epidemic of staggering progression," said Dr. Douglas Greene, Sanofi Aventis' vice president of regulatory affairs.

The new study went on to test whether staying on the drug kept people from regaining weight. Those who took Acomplia during the first year were redivided to either continue on it or get fake pills for the second year.

At the end of the two years, 62.5 percent of people on the higher dose had lost 5 percent of their body weight compared to 36.7 percent on the low dose and 33.2 percent on fake pills.

Some people on the drug had nausea, but it usually was short- lived. Rates of anxiety and depression were no greater for those on Acomplia than those getting fake pills.

"The results are very encouraging. The safety profile looks good. It seems like people tolerate the medication," said Dr. Sidney C. Smith Jr., a University of North Carolina cardiologist who had no role in the study.

The company has not yet said whether it will seek approval to sell the drug for obesity and smoking cessation. The only study reported so far of Acomplia in smokers lasted only 10 weeks and found that 28 percent on the drug kicked the habit versus 16 percent on dummy medication. Two longer, larger studies of this are in the works, along with another study of Acomplia in diabetics.

Sanofi Aventis is the world's No. 3 pharmaceutical company by sales, behind U.S. giant Pfizer Inc. and Britain's GlaxoSmithKline PLC.

Source: Columbian

More News in this Category