Merck Pill Derived From Pot Research Curbs

Merck & Co.s experimental diet pill, developed using research on marijuana, may curb the munchies and lead to Weight Loss, a study says.Patients taking the pill, taranabant, lost an average of 6 to 12 pounds, depending on dose. Those given a placebo lost about 3 pounds during the 12-week study, published today by the journal Cell Metabolism. The research is in the second of three phases of testing needed for U.S. marketing approval.

About 31 percent of Americans over the age of 20 have abnormally high body fat, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The drug targets a receptor found in the brain and gastrointestinal tract discovered through study on marijuana, the researchers wrote.

“It’s known that when you smoke marijuana, which is a natural chemical that stimulates the receptor, the marijuana has beneficial effects on nausea,” said Steven Heymsfield of Merck, the study’s head researcher. The effect on the receptor, called CB1, explains why, he said.

Unlike marijuana, taranabant blocks the CB1 receptor, suppressing appetite. Side effects include anxiety, nausea, vomiting and frequent bowel movements, according to the study. All were more pronounced in the higher doses.

Larger studies will be done to determine the specific profile of the side effects, Heymsfield said. A bigger trial, the third phase of marketing tests, will end this year, he said.

The major hurdle is psychiatric,” Heymsfield said. We know with what we’ve seen that there are some effects of anxiety and depression related to the mechanism of the drug.”

Shares Rise

Merck, based in Whitehouse Station, New Jersey, rose $1.74, or 3 percent, to $59.66 at 4:05 p.m. in New York Stock Exchange composite trading, the biggest increase since October. The stock has increased 35 percent in the past 12 months.

Merck said last month that it expects to file for marketing approval of taranabant by the end of 2008. Spokesman Ian McConnell declined to give a peak-sales forecast for the drug.

A similar drug, Sanofi-Aventis SA’s Zimulti, was withdrawn by the company from consideration for marketing approval after an advisory panel found that the company’s safety data were insufficient and that the weight lost in clinical trials didn’t justify the danger of psychiatric or neurological side effects. Paris-based Sanofi has said it will resubmit the pill to the U.S. Food and Drug Administration.

FDA Delay

The FDA had delayed a decision on the drug, marketed as Acomplia outside the U.S., three times because of concerns it was unsafe. U.S. regulators reviewing the company’s application found that people who took the drug were twice as likely to have thoughts of suicide as those on a placebo.

Three patients taking the drug killed themselves during clinical trials, Sanofi officials said in June 2007.

Obese patients taking Acomplia, whose chemical name is Rimonabant, were three times as likely as those taking a placebo to develop anxiety, according to a study published in November in the U.K. medical journal The Lancet.

“The balance, of course, is the efficacy and the safety, and that’s where rimonabant had questions about whether the benefits were balanced by adverse affects,” said Christopher P. Cannon, a doctor at Brigham and Women’s Hospital in Boston, in a telephone interview last week.

The effects demonstrated in this study are similar, though not identical, said Cannon, who has consulted for Sanofi. He said other doctors have told him that Acomplia has helped their patients lose weight and that the neurological side-effects have been manageable.

New Family

Both pills belong to a new family of drugs that block receptors in the brain and organs linked to hunger signals. The so-called CB1 receptors, when working properly, help regulate food intake and how the body uses and stores fats and sugars.

CB1 receptors were discovered by scientists attempting to understand the psychoactive components of marijuana. They found that the body produces similar chemicals of its own, called endocannabinoids. These chemicals may stimulate food intake. Acomplia and taranabant work by partially blocking the receptor so that fewer endocannabinoids can be sensed.

elopatto[@]bloomberg.net.

PS: you can buy Acomplia on this site.

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