Bad news for anti-obesity drug Acomplia *
The United States can probably kiss goodbye to the arrival of Sanofi-Aventis' anti-obesity rimonabant (Acomplia). The European Medicines Agency, which assesses the safety of drugs after they have been released, has recommended that marketing authorization of Acomplia be suspended across the European Union.
The drug has been available in Europe since 2006, although it is not yet available in the U.S. In 2007, the Food and Drug Administration denied approval of Acomplia in the U.S., citing safety concerns.
In a release, the European Medicines Agency said it had concluded that "the benefits of Acomplia no longer outweigh its risks" and that studies not available at the time of the drug's approval, as well as experiences of patients who'd taken the drug since then, indicated "an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking a placebo."
Warnings about these side effects had always accompanied the drug, and last year the agency acted to counter-indicate prescription to anyone suffering from depression (the principal side effect) and to warn doctors that the drug should be discontinued if the patient developed depression.
But the extent of the effects appeared higher after more studies were examined, the agency said. At the same time, the weight loss experienced by users in the real world was less than the studies had suggested because people don't tend to take the drug for very long.
The European Medicines Agency's announcement is a recommendation. Next, the European Union will decide what to do on the matter. But it doesn't look good for the drug, according to several news reports: In a Bloomberg News article, an analyst called this the "death knell for the drug."
Acomplia acts kind of like an anti-marijuana: It blocks a receptor in the brain that is activated by THC, the main active ingredient in the plant. (Just as THC stimulates the appetite, Acomplia does the opposite--suppresses it.) That receptor is present in many different regions of the brain and other parts of the body.
Earlier this month, another drug based on the anti-THC principle went south. Merck's experimental drug taranabant was abandoned by the company after Phase 3 studies showed that though it helped people lose weight it had too many side effects.
-- Rosie Mestel
* UPDATE: They come, they go, they come, they go. Also in the news right now: reports of a new promising anti-obesity drug, tesofensine, in the journal the Lancet. (Because that journal won't let you read for free, check it out instead at WebMD.) "Normally the drugs now on the market give you at best a weight loss of 5 kilograms [11 pounds] with diet and exercise," says study author Dr. Arne Astrup of the University of Copenhagen in the WebMD article. "In this study we doubled that weight loss."
But let's wait before we get too excited. The WebMD article also quotes Thomas Wadden, director of the University of Pennsylvania School of Medicine Center for Weight and Eating Disorders, as saying larger studies are needed, in spite of the promising results. Wadden cites blood pressure side effects as troubling, "as was the finding that study participants treated with tesofensine reported more anger, hostility and confusion than participants in the placebo arm of the study."
Illustration: Robert Neubecker / For The Times