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Orexigen Therapeutics Inc. said Thursday that their experimental drug for weight loss, Contrave, met their primary and secondary goals, according to results of the first late-stage trial. Even so, the drug did not meet the Food and Drug Administration’s requirements, which say a weight loss drug must result in more than 5 percent weight loss to 35 percent of the participants in a trial in order to be approved. The difference in the average weight loss between the drug and placebo patients was 4.2 percent.
“The data looked good but not as good as a lot of people were expecting. They missed,” said Adam Cutler, an analyst with Cannacord Adams in New York.
Contrave, a combination of the antidepressant bupropion and naltrexone, helped patients taking it in the study to lose 9.3 percent of their body weight, while those in the control group lost 5.1 percent. Both groups were assigned to regular exercise, counseling sessions and diet.
The study involved 793 patients. The company said 26 percent of those taking Contrave dropped out due to side effects, including nausea, hives, headache, anxiety, dizziness and constipation. Only 13 percent of those in the placebo group left the trial due to side effects.
Orexigen said it has three other late-stage studies on Contrave, with results due in mid-2009 and hopes for an FDA application by the end of the year. Chief Medical Officer Eduardo Dunayevich said in a statement that although the drug failed to meet FDA expectations, the results still “indicate that additional, clinically significant weight loss can be achieved when Contrave is added to a rigorous program of diet and exercise.”
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