Published: June 3, 2011Orexigen Therapeutics, the maker of a weight-loss drug once seen as a potential blockbuster, said it was scrapping its bid for approval in the United States because of “unprecedented” demands by regulators on safety trials. Orexigen said that it would focus on developing the drug, Contrave, and another drug candidate, Empatic, in markets outside the United States until there was a clear pathway to approval in the United States. The Food and Drug Administration refused to approve Contrave in February because of concerns about its effects on the heart. Orexigen said the F.D.A. wanted it to conduct a study on Contrave’s heart side effects that is unprecedented and would generate much more information than necessary or feasible. As recently as 2010, Contrave was seen as a highly promising obesity drug. Stock in Orexigen, which is based in San Diego, fell $1.06, or 33 percent, to $2.12 a share.
fat gene theory dispelled