Drug Maker and FDA Revive Diet Pill Study - New York Times (blog)

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Is the Food and Drug Administration loosening its tough stance on diet drugs?

Orexigen Therapeutics said on Tuesday that it was reviving development of its experimental obesity drug, Contrave, after receiving a letter from the F.D.A. outlining the design of a clinical trial that could lead to the drug's approval as early as 2014.

Even though its advisory committee had recommended approval of Contrave, the F.D.A. turned down the drug this year, citing concerns about possible cardiovascular risks.

Contrave was the third of three new obesity pills to be rejected in rapid order by the agency, prompting some researchers, advocates and investors to complain that it was setting an unreasonably high safety bar even as obesity had become a huge public health problem.

Then in June, Orexigen announced it was suspending development of Contrave for the American market because the F.D.A. was requiring a trial to rule out that the drug raised the risk of heart attacks. The trial, the company said, would be "unprecedented'' and so large that it would not be feasible.

But Orexigen, which is based in San Diego, said Tuesday that after further discussions with the F.D.A., the trial design had become more reasonable, requiring fewer than 10,000 patients and less than two years to get to an interim analysis of the data that could provide grounds for approval.

The new criteria are "reasonable, feasible and provide the certainty required to proceed with the study,'' Michael Narachi, the company's chief executive, told analysts Tuesday afternoon. Takeda would market the drug in the United States should it win approval.

Mr. Narachi said that pressure from elected officials and advocacy groups and prestigious scientists might have helped sway the F.D.A. "This was a multipronged effort that we built to create some momentum,'' he said.

Earlier this month, for instance, the Senate Appropriations Committee expressed its concern about the absence of novel medicines to treat obesity, the second leading cause of preventable deaths in the United States. It instructed the F.D.A. to report by the end of next March on the steps it would take to support the development of new treatments for obesity.

Another company that had its obesity medicine rejected, Vivus, said last week that it would reapply by the end of October for approval.

The F.D.A.'s main concern with the Vivus drug, called Qnexa, was that it might raise the risk of birth defects. Vivus said it would apply first for approval for patients other than women of child-bearing age while it completed a study assessing the risk of birth defects.

A spokeswoman for the F.D.A. said the agency was not changing its standards, that it had always said it would work with drug companies with the goal of approving safe and effective drugs for obesity.

Even with what it deems a more reasonable F.D.A. stance, Orexigen still faces challenges. The company estimates the trial will still cost about $100 million, a large amount for a small company with only $70 million in cash. And the F.D.A. is planning an advisory committee meeting for early next year that is expected to discuss whether all makers of obesity drugs will need to run clinical trials to rule out an elevated risk of heart attacks.

21 Sep, 2011

Source: http://news.google.com/news/url?sa=t&fd=R&usg=AFQjCNEBq-hUDo_37yTOYAx9cVOnYrR8og&url=http://prescriptions.blogs.nytimes.com/2011/09/21/drug-maker-and-f-d-a-revive-diet-pill-study/
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