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Experimental Diet Pill Curbs Appetite In 12-Week Study

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Bloomberg News

Published: January 9, 2008

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 six to 12 pounds, depending on dose. Those given a placebo lost about three pounds during the 12-week study, published Tuesday 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 older than 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.

"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 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."

Merck stock rose $1.74 to $59.66 on Tuesday.

Merck said last month it expects to file for marketing approval of taranabant by the end of this year.

A similar drug, Sanofi-Aventis SA's Zimulti, was withdrawn by the company from consideration for marketing approval after an advisory panel found that the company's safety data were insufficient and that the weight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.

The FDA had delayed a decision on the drug, marketed as Acomplia outside the United States, 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.

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