FDA throws curve to new diet drug

WASHINGTON, D.C.; February 6, 2011

However, the Food and Drug Administration has reversed the decision of its expert panel, and put a hold on the drug Contrave until more tests could be done.

The delay runs the risk of quashing development of the drug entirely, by draining the financial resources of the small company developing it.

In its ruling, the Food and Drug Administration expressed concerns abvout the heart side effects of Contrave.

Contrave, which combines an anti-addiction drug to suppress appetite with an antidepressant, was the most promising in a class of new diet drugs. Several others in that field have already been rejected.

Temple University's Center for Obesity Research and Education led local trials of the drug. And officials there were impressed with its performance. Four out of 10 patients taking Contrave for a year lost at least 5 percent of their body weight. Those results narrowly met FDA's guidelines for effectiveness.

The FDA's ruling was its third rejection of a weight loss drug in recent months, raising questions about whether ANY weight loss drug will pass agency muster.

For Orexigen, the FDA rejection touched off a stock market sell-off which wiped out three-quarters of the company's market value. the cardiac tests can take years to conduct, and will cost millions of dollars. However, company executives say they want to cooperate with the FDA, to get Contrave approved.

Copyright © 2024 WPVI-TV. All Rights Reserved.