A Food and Drug Administration (FDA) panel yesterday recommended the approval of Orexigen Therapeutics’ weight loss drug Contrave. This is the first time a weight loss drug has received the nod. The vote went 13 to 7 for Contrave’s approval and 11 to 8, with an abstention that additional studies be conducted on heart risks. Although experts agree to risks they believe the benefits outweigh the risks. Although the FDA is not compelled to go with the panel’s recommendation, it more often than not does. The FDA will deliver its verdict by Jan. 31 2011.
Like most weight loss drugs Contrave too caries heart-disease risks. In the clinical trials from the company elderly subjects were not included. That lack of data made it difficult to determine the drug’s safety in patients at risk for heart attack and stroke. Contrave consists of antidepressant bupropion with the anti-addiction drug naltrexone. Both these components carry a risk of high blood pressure, dizziness and insomnia. The studies showed that patients taking the drug, on average, lost 4.2 percent more weight than patients taking a placebo. FDA guideline however says that there should be at least a 5 percent difference in weight loss between the groups. But 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.
The FDA panel in October rejected Arena Pharmaceuticals’ lorcaserin and Vivus’ Qnexa because of safety concerns. 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 linked to potential heart problems and birth defects. Lorcaserin was linked to cancerous tumors found in laboratory rats. With rising epidemic of obesity and a dearth of safe weight loss drugs new weight-loss therapies are desperately needed.
According to Dr. Sidney Wolfe, director of Public Citizen’s health research group, “The diet pill Contrave is the latest in a long line of dangerous and, ultimately, failed weight loss drugs.” He said it would need to be removed from the market eventually. Orexigen President and CEO Michael A. Narachi however remains unsurprised at the acceptance or criticism. He said, “The meeting today was incredibly valuable across the board on the input… We look forward to incorporating the input we got today to move the program forward.”