Junkfood Science: Say Good-bye to Acomplia...for now

June 30, 2007

Say Good-bye to Acomplia...for now

We all remember last December when every story in the media was selling the wonders of the “Miracle Drug,” Acomplia. Meanwhile, Junkfood Science readers got the real scoop on the evidence from the clinical trials.

Since then, things haven’t looked good for the FDA approving Accomplia for sale in the U.S. The FDA first put it on the slow track for approval due to concerns over its efficacy and safety, and then an FDA advisory panel failed to recommend it for approval.

Today, Sanofi announced that it was withdrawing its FDA application for Acomplia. They haven’t given up on their efforts to sell it in the U.S., however. By withdrawing their application, they avoid outright rejection of the drug by the FDA and can modify their application and come back and try again, claiming it’s a treatment for something else, such as diabetes. The company spokespersons haven’t said how they will get around the side effects. The European Medicines Agency is currently reviewing those and is expected to announce its conclusions in a few weeks.

It remains to be seen what this will mean for the other pharmaceutical companies with their own brand names of cannabinoid-2 receptor antagonists — Merck’s Taranabant and Pfizer’s CP 945598.

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