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  Diet Drug Report for Oct. 2008 -- News About Diet Drugs
  Merck, Citing Side Effects, Pulls the Plug on Diet Drug Taranabant
 

Merck & Co. announced on Oct. 2 that it was pulling the plug on its experimental diet drug taranabant because it was unable to find a dose that brought about significant weight-loss with a minimum of side-effects.

Merck said taranabant, which like rimonabant acts by blocking certain cannabinoid receptors (CB-1 receptors) that regulate appetite, was associated with increased risk of psychiatric events -- the factor that has kept Sanofi's diet drug Acomplia (rimonabant) off the U.S. market.

Merck said in its announcement that both effectiveness and side effects are dependent on dose levels, with higher doses producing greater weight-loss but more adverse events.

"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses," said John Amatruda, Merck's senior vice president and research head for diabetes and obesity.

"Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity.," he added.

Five clinical trials of the drug are being halted, said Merck spokesperson Amy Rose.

While Merck was testing its drug at a variety of lower dose levels than the dosage approved for Acomplia, which is available in the European Union and a number of other countries, Merck essentially conceded that dose levels that minimize risk do not adequately help people lose weight.

While Acomplia continues to pursue development of Acomplia, Merck's halt to development of taranabant suggests that this class of drugs -- if submitted for new indications such as diabetes -- is likely to face tough scrutiny from both U.S. and European regulators.

Pfizer continues to have a CB-1 receptor antagonist in late-stage clinical trials, according to an update this week of the company's pipeline, but a spokesperson declined comment today on the drug's future.

 

Rimonabant Report

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Last Updated: 10/02/2008 Copyright 2004-2007 Medical Week News, Inc. All Rights Reserved