A company that is seeking to have its weight reducation drug put on the market says that federal regulators are asking for "unprecedented" demands when it comes to all of the safety trials that they are having to do for their obesity drug candidate Contrave.
Orexigen Therapeutics Inc. says it will put further development on hold until it is clear how it can get the drug approved.
The Associated Press reports that, "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."
The company is saying it will work to move faster to get the product out to other markets. They have decided to halt U.S. work on two products, Contrave and Empatic, until all the regulatory issues are wrapped up.