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Contrave Now Faces Full FDA Approval

Dec. 7, 2010 -- After back-to-back rejections of drugs targeting obesity in the last six months, an FDA advisory committee today voted 13-7 in favor of approving a new medication aimed at aiding people in losing weight and maintaining that weight loss.

The drug, made by Orexigen and to be marketed as Contrave if granted final approval by the FDA, will become one of the few drugs available for the treatment of obesity. The FDA’s decision is due by Jan. 31.

“Clinicians and patients need additional options,” said John Buse, MD, of the University of North Carolina School of Medicine, who addressed the Endocrinologic and Metabolic Drugs Advisory Committee on the drugmaker’s behalf. The risk-to-benefits ratio, he said, “falls clearly on the side of benefits.”

In general, the committee agreed with that statement. However, serious concerns about the drug’s impact on cardiovascular health were the subject of much of the day’s discussion. Supporting documents submitted by the manufacturer showed that the blood pressure of some patients taking Contrave in clinical trials went up as their weight went down.

“I am most distressed about this particular adverse effect,” said committee member Jules Hirsch, MD, of Rockefeller University in New York City. “There needs to be very, very careful attention if this drug is approved.”

To that end, the committee voted 11-8 to require Orexigen to study their drug’s impact on heart health following its approval. In July, they rejected an obesity drug application from drugmaker Vivus; two months later, they voted against Arena Pharmaceutical’s proposed obesity medication, lorcaserin. The FDA formally rejected both drugs in October.

Modest Weight Loss From Contrave

Contrave is a combination of two drugs, both of which have been on the market for about 25 years. Bupropion, commonly prescribed to treat depression and also approved to help people quit smoking, curbs the appetite, while naltrexone, approved to treat opioid and alcohol addictions, amplifies this effect.

That effect may not lead to dramatic weight loss, however. Most patients taking Contrave in clinical trials lost about 5% of their starting body weight.

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