February 1st, 2011
12:41 PM ET
Another weight-loss drug brought to the U.S. Food and Drug Administration for approval has been rejected.
In the last 12 months, the FDA has nixed three new weight-loss drugs, lorcaserin because of possible links to cancer, Qnexa and now Contrave because of possible heart problems.
In December, an advisory committee for the FDA first voted in favor of Contrave, a weight-loss drug that combines naltrexone and bupropion. That committee also voted 11 to 8 that the company, Orexigen should examine the drug's risk for major adverse cardiac events.
But, the FDA does not always follow the advisory committee's suggestions. The agency rejected Contrave because of concerns about the cardiovascular safety after long-term use.
In a letter, the FDA told Orexigen, the company which created Contrave that it must “conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."
Michael Narachi, Orexigen’s president and CEO, said in a press release that they were “surprised and extremely disappointed” and said: "We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the Contrave application."
Contrave contains naltrexone, used to treat alcohol and cocaine addiction, and bupropion, an antidepressant, which also helps people quit smoking.
Contrave would’ve been used by patients whose initial body mass index is greater than 30 (obese) or 27 and greater (overweight) with one or more health risk factors such as diabetes or hypertension. For an example, a man who is 5 feet and 10 inches and weighs 210 pounds would have a BMI of 30 and could be eligible to take the drug.
In the clinical trials, subjects who took the drug had modest weight loss - at least 5 percent of their body weight.
The subjects also had a small increase in blood pressure and pulse rate compared with the placebo group, and the “hypertension-related adverse events was significantly higher” in the drug group compared with the placebo subjects.
This is the last of the weight-loss drugs reviewed by the FDA in 2010, which have all seen uphill battles.
Last year, an advisory committee rejected Qnexa, citing concerns ranging from heart issues to psychiatric side effects. Another drug, lorcaserin was rejected after questions about the drug’s effectiveness and tumor development in rat studies. A previously approved drug, Meridia made by Abbott Laboratories was voluntarily withdrawn from the market in October due to an increased risk for heart attack and stroke.
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