FDA Rejects Promising Diet Pill Drug

Orexigen Therapeutics Inc. said Tuesday that U.S. health officials have rejected its experimental weight loss pill Contrave and requested a new study of its potential heart risks.

The unexpected announcement marks the Food and Drug Administration’s third rejection of a weight loss drug in recent months, raising questions about whether any new drugs in the class can be made safe enough to win approval.

The FDA has not approved a new diet pill for over a decade.

The FDA request for an additional study suggests that the agency may still approve the drug, but is making a difficult path in order to do so. 

Orexigen said it is disappointed with the FDA’s decision and will work with the FDA to determine its next step.

"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 Dec. 7 advisory committee meeting," said President and CEO Michael Narachi, in a conference call with investors.

Narachi said the studies of the kind requested by the FDA are normally "fairly large" and would require the company to raise more money.  Clinical trials to study rare events like heart attack can take years to conduct and cost millions.

Analysts viewed Contrave as the most promising of three new diet pills recently submitted to the FDA.

The drug is a combination pill, mixing an antidepressant with an anti-addiction drug to curb appetite. Four out of 10 patients taking Contrave lost 5 percent of their body fat in a year. 

According to drug industry analyst Erik Gordon, given the drug’s limited benefit, the agency’s rejections is not surprising.

"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," Gordon, a professor and analyst at University of Michigan’s Ross School of Business, told The Associated Press.

Orexigen does not currently have any products on the market, making Contrave a key to the company’s growth and survival. 

Analysts expect any obesity drug reaching the market to have the potential to become a billion-dollar seller.

The FDA acknowledged the need for new weight loss drugs.  However, the agency rejected two other drugs last year due to safety risks, a long-standing issue that has plagued weight loss treatments for decades. 

Vivus Inc. and Arena Pharmaceuticals Inc made those drugs.  Both companies said they plan to resubmit their drugs for approval.

Contrave has been pegged as a more promising treatment because of its safety.  Unlike the other two drugs, it received a positive vote from the FDA’s panel of outside advisers, who voted 13-7 that the drug’s modest weight loss benefits outweighed its risks.

However, the FDA meeting assessing the drug was not free of criticism.  FDA scientists and safety advocates complained that the company enrolled few elderly patients or patients with a history of heart disease in its trials.

Heart side effects have been an issue with diet drugs as well.  Abbott Laboratories withdrew its drug Meridia after evidence found that it increased the risk of heart attack and stroke.

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On the Net:

• Orexigen Therapeutics Inc.
• Food and Drug Administration
• Contrave