Tags: Orexigen | Weight | Loss | Drug | FDA

FDA Panel Recommends Approval for Orexigen Weight-Loss Drug Contrave

Wednesday, 08 Dec 2010 09:49 AM

A Food and Drug Administration panel on Tuesday recommended that the agency approve Orexigen Therapeutics Inc.'s weight loss drug Contrave, making it the first in group of competitors to get a positive nod from experts.

The panel of experts voted 13 to 7 for Contrave's approval, and 11 to 8 that additional studies be conducted on heart risks. Experts had voiced safety concerns on the drug, but determined the benefits outweigh the risks. The move marks an about-face on weight loss drugs after the agency in October rejected Arena Pharmaceuticals Inc.'s lorcaserin and Vivus Inc.'s Qnexa because of safety concerns.

The FDA is not required to follow the advice of its expert panels, but often does. The agency is scheduled to make a decision on Contrave by Jan. 31.

Scientists at the FDA had been concerned over Contrave's effects on the heart, an issue that has weighed heavily on potential weight loss drugs. Complaints focused on the company's lack of elderly patients with a history of heart disease in clinical trials. That lack of data made it difficult to determine the drug's safety in patients at risk for heart attack and stroke.

Contrave is a combination pill, mixing the antidepressant bupropion with the anti-addiction drug naltrexone. The FDA reported higher rates of side effects already linked to the drugs, including high blood pressure, dizziness and insomnia.

Also, the company didn't quite meet all the criteria the agency had set for obesity drugs. Studies showed that patients taking the drug, on average, lost 4.2 percent more weight than patients taking a placebo. But, those results did not meet an FDA guideline that there should be at least a 5 percent difference in weight loss between the groups. The drug did meet a second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight.

U.S. obesity rates are near 35 percent among adults, and physicians and health officials have said new weight-loss therapies are desperately needed. But the search for that treatment has been fraught with safety issues. Earlier this year, Abbott Laboratories' Meridia weight loss pill was pulled from the market because of concerns over the risk of heart attack and stroke.

Qnexa was rejected in part because it was linked to potential heart problems and birth defects, despite showing significant effectiveness. Lorcaserin faced concerns over cancerous tumors found in laboratory rats.

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A Food and Drug Administration panel on Tuesday recommended that the agency approve Orexigen Therapeutics Inc.'s weight loss drug Contrave, making it the first in group of competitors to get a positive nod from experts.The panel of experts voted 13 to 7 for Contrave's...
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Wednesday, 08 Dec 2010 09:49 AM
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