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Pfizer Halts Obesity Drug Trial

Posted by Chrissie Cole
Thursday, November 06, 2008 12:04 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Pfizer, Obesity, Taranabant, Merck, Sanofi Aventis, Acomplia

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IMAGE SOURCE:© Pfizer Web site banner

Pfizer Inc. the world’s largest drug company has halted testing on an obesity drug similar to the ones recently canned by other drug company’s because U.S. approval would be too costly, slow and risky.

In a statement, the company said, “Pfizer is unwilling to pour money into new human trials the FDA is likely to require. The drug, known by the chemical name CP-945,598 was in the Phase III trials required for market approval and had the potential to make more than $500 million in annual sales, analysts said.

Pfizer is the latest drug maker to discontinue its obesity drug that blocks the same brain receptor that makes marijuana smokers hungry.

The FDA has expressed apprehension that blocking that chemical could increase the risk for other health conditions including mood disorders and neurodegenerative disorders such as multiple sclerosis.

On October 2 Merck & Co. halted development of its proposed anti-obesity drug taranabant, which was linked to psychiatric side effects in clinical trials.

“We remain confident in the safety of the compound and believe this is the right decision based on all available information regarding this class of agents, as well as recent discussion with regulatory authorities, said Martin MacKay.

The statement said the company believes the compound "has the potential to be a safe and effective treatment for weight management."

Both Sanofi and Merck's obesity drug were linked to depression and suicide. Bristol-Myers Squibb, Co., is the last major drug maker still developing an obesity drug, according to Bloomberg.

European regulators recently ordered Sanofi-Aventis to withdraw its weight-loss drug Acomplia across the Europe Union, sending a crippling blow to the French pharmaceutical group.

After reviewing data that suggests obese and overweight patients had twice the risk of developing psychiatric disorders such as depression, anxiety and aggression, than those on a placebo, The European Medicines Agency (EMEA) determined the benefits no longer outweighed the risks for the drug – generically known as rimonabant. #


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