NEW YORK (AP) — Orexigen Therapeutics Inc. says regulators are making "unprecedented" demands about safety trials for its obesity drug candidate Contrave, and says it will put further development on hold until it is clear how it can get the drug approved.
The San Diego company says the Food and Drug Administration wants it to conduct a study on Contrave's heart side effects that is unprecedented and would generate much more information than is necessary or feasible. The FDA said in February that Orexigen would need to conduct a new study of Contrave's heart side effects in order to get Contrave approved.
Orexigen says it will speed up exploration of non-U.S. markets. It will put U.S. development of its obesity drugs Contrave and Empatic on hold until the regulatory issues are resolved.