Although obesity is a heavy epidemic in the United States and internationally, the FDA has rejected two weight loss drugs in the second half of 2010 and most recently dealt a heavy blow to Contrave, which was developed by fledgling California company Orexigen. This leaves more than 10 years without a weight control medication on the market and leading scientists back to the drawing board. Orexigen’s stock has free dived by 71% since the announcement.

President and CEO Michael Narachi stated in a response:

“We are surprised and extremely disappointed with the Agency’s request in light of the extensive discussion and resulting vote on this topic at the December 7 Advisory Committee meeting. We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the Contrave application.”

Contrave is a combination pill, mixing an antidepressant with an anti-addiction drug to curb appetite. Four out of 10 patients taking Contrave for a year lost at least 5 percent of their body weight. Those results narrowly met FDA’s guidelines for effectiveness and the Association also voiced concerns over potential heart risks.

In December 2010, it was reported that an FDA advisory committee voted 13-7 that the modest weight-loss benefits of an investigational combination of naltrexone and bupropion, outweigh the drug’s blood pressure risk.

This combo was the last in a trio of new weight-loss drugs that went before FDA panels 2010, striving to be the latest treatment in the dwindling field of medications to fight obesity. The previous two drugs, phentermine/topiramate (Qnexa) and lorcaserin hydrochloride (Lorqess) were both rejected by the FDA after they fared poorly at advisory committee meetings.

In the past few weeks, FDA scientists and safety advocates complained that the company enrolled few elderly patients or patients with a history of heart disease in its trials, making it difficult to determine the drug’s safety in patients who are likely to need it most.

Heart side effects have been an issue with diet drugs, most notably with Wyeth’s diet drug combination fen-phen, which was pulled off the market in 1997. In October, Abbott Laboratories withdrew its drug Meridia after evidence it increased the risk of heart attack and stroke.

Currently there is just one prescription drug on the market for long-term weight loss: Roche’s Xenical, which is not widely used. Several other generic drugs are approved for short-term weight loss, including phentermine.

Erik Gordon, professor and analyst at University of Michigan’s Ross School of Business comments on the ruling:

“You have life-threatening possible side effects in return for modest weight loss that might not be produced in the real world – no wonder the FDA wants more data.”

The U.S. obesity rate for adults nears 35%, and the FDA has acknowledged the need for new weight loss drugs.

Source: Orexigen

Written By Sy Kraft, B.A.