September 22, 2011
FDA Reconsidering Weight-Loss Drug
The Food and Drug Administration (FDA) told Orexigen Therapeutics on Tuesday that it will reconsider the company's weight-loss drug Contrave.
The FDA informed the company it would reconsider it for approval if a clinical trial removes any concern about risks to the heart.
The company said the FDA's requirements are "reasonable and feasible" and it plans to go ahead with the trial.
Contrave is a combination of bupropion and naltrexone and causes a person's appetite to diminish and metabolism to rise.
Clinical trials of the drug showed that 50 percent of people taking it were able to lose 5 percent of their body weight over a year, compared with only 10 percent in a group that received a placebo.
The FDA decided to reject Contrave because many people experienced slight increases in blood pressure or pulse rates.
Orexigen said the new study would required thousands of patients and the interim results could be found in two years after the trial begins in 2012.
The company's shares jumped 87 percent in after-hours trading after the announcement.
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