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Orexigen's Two-Drug Obesity Pill Cuts Hunger, Cravings, Weight in Study
Obese patients who took Orexigen Therapeutics Inc.’s experimental pill combining an anti- addiction drug and an antidepressant lost more weight than those who took a placebo, a company-sponsored study found.
Patients who took the Orexigen pill, Contrave, and were given diet and exercise suggestions shed 5 percent to 6 percent of their body weight compared with an average weight loss of 1.3 percent among those taking placebos.
La Jolla, California-based Orexigen is racing with Vivus Inc. and Arena Pharmaceuticals Inc. to bring weight-loss drugs to market. Applications from all three are pending before the U.S. Food and Drug Administration. Agency advisers recommended against approving the Vivus drug on July 15 citing safety concerns, some of which have plagued previous weight-loss drugs. In January, Abbott Laboratories pulled Meridia from the European market at the urging of regulators concerned about heart risks.
The Meridia experience “perhaps suggests that more data are needed to get a better overall assessment of cardiovascular risk of this otherwise promising combination,” said Arne Astrup, a professor in the Department of Human Nutrition at the University of Copenhagen, in an editorial accompanying the Contrave study. Both articles were published today in the journal Lancet.
Contrave combines two currently marketed drugs, naltrexone, used to reduce the urge to consume alcohol or addictive drugs, and bupropion, an antidepressant also used to combat smoking addiction.
Blood Pressure
Both drugs are known to increase blood pressure, Astrup said in his commentary. Among the study patients, those taking Contrave had the blood pressure rise slightly in the first month, then drop slightly for the remainder of the trial. It didn’t drop significantly, as usually occurs when patients lose weight, Astrup said.
Study patients took a fixed dose of bupropion and either a higher or lower dose of naltrexone. A third group was given placebos. All were prescribed a reduced-calorie diet and exercise.
Participants had a body-mass index, or BMI, of 27 to 45. A BMI of 30 or more is considered obese, equivalent to 180 pounds for an adult 5 feet 5 inches tall. Those with a BMI of 25 to 30 are considered overweight.
Among the 1,453 patients whose results were assessed, those taking the high-dose combination had a median loss of 13.4 pounds, about 6.1 percent of their body weight. The lower-dose group lost a median 10.8 pounds, or 5 percent of their body weight. Members of the placebo group lost 3.1 pounds, or 1.3 percent of their body weight.
Weight-Loss Performance
Not all the patients completed the 56-week trial. In the smaller group of patients who did, weight loss was greater, said Frank Greenway, the lead author of the study. The weight loss for people in the high-dose group who made it all the way through the study was 17 pounds, or 8.1 percent of their body weight; the lower-dose group lost 14.3 pounds, or 6.7 percent; and the placebo group lost 4.2 pounds, or 1.8 percent of body weight.
“That’s better than either of the two drugs that are presently on the market” in the U.S., said Greenway, head of clinical trials for the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge. Those drugs are Meridia and GlaxoSmithKline Plc’s Xenical. Greenway is also a consultant and member of the scientific advisory board for Orexigen.
Cravings and Rewards
The two drugs that make up Orexigen’s new pill target different parts of the brain, one that influences appetite and the other that affects cravings and rewards, Greenway said.
“This is first obesity drug I’m aware of that appears to have a significant effect on the reward system and it represents something new and unique that will address issues some people have that may not have been addressed in the past,” Greenway said yesterday in a telephone interview.
The most common side effect was nausea, experienced by 30 percent of the high-dose group and 27 percent of the lower-dose group. Headaches and constipation were also experienced by more than 14 percent of those taking the drug.
The FDA is slated to decide on the drugs from San Diego- based Arena and Mountain View, California-based Vivus by late October and on the Orexigen pill by Jan. 31.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
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