FDA Looks At New Orexigen Weight Loss Pill
The Food and Drug Administration says a pill to treat obesity from Orexigen Therapeutics Inc. helped patients lose weight, though it didn’t meet all the criteria set forth by the agency.
Orexigen’s pill Contrave is the third weight loss pill to be reviewed by the FDA this year. FDA officials have acknowledged the need for new weight-loss drugs amid an epidemic of U.S. obesity, though the agency rejected the other two medications due to safety concerns.
Contrave did meet a second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight. FDA guidelines published in 2007 state that a drug can be considered effective if it meets this requirement.
In documents posted online Friday, the FDA said studies by Orexigen showed patients taking its drug lost, on average, 4.2 percent more weight than patients taking a placebo. However, these results did not meet an FDA guideline that there should be at least a 5 percent difference in weight loss between the groups.
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential.
But the search for a drug that helps patients safely shed pounds has been largely unsuccessful. Earlier this year Abbott Laboratories’ Meridia weight-loss pill was pulled from the market after regulators said it increased the risk of heart attack and stroke.
The FDA will ask a panel of experts to vote on the drug’s efficacy and safety tomorrow, December 7. Orexigen’s briefing documents for the December 7 panel hearing can be found here.