A safety study of obesity drug Contrave has been terminated after Orexigen Therapeutics released early, misleading trial data, say researchers.
La Jolla, California-based Orexigen disclosed in March early clinical trial results, which showed its drug Contrave had a 41 percent reduction in cardiovascular-related deaths. But as study participants were followed for a longer period of time, the drug’s heart benefit has vanished, according to updated results released Tuesday by the Cleveland Clinic.
Cleveland Clinic researchers criticized the company for “violating the data access agreement” in releasing the early data, saying the trial’s integrity has been compromised, reports The New York Times.
“We felt it was unacceptable to allow misleading interim data to be in the public domain and be acted upon by patients and providers,” Dr. Steven Nissen, chair of cardiology at the Cleveland Clinic and lead researcher on the 9,000-patient study, said in an interview.
The U.S. Food and Drug Administration (FDA) has instructed Orexigen conduct a second, larger cardiovascular-safety drug study for Contrave. A new trial would cost about $200 million, reports Bloomberg Business. Originally, Orexigen and partner company Osaka, Japan-based Takeda planned to split the cost of the trial. But since the end of the obesity drug study, Takeda is insisting Orexigen pay the entire cost of the new cardiovascular trial and is seeking to end its collaboration agreement with Orexigen.
In a statement on Tuesday, Orexigen denied misleading patients or investors, saying that it “plainly and clearly” stated that the released data was preliminary.
Contrave, which was approved in September, is one of four new prescription weight-loss drugs that have come to market since 2012.
Shares of the biotech company fell 14 percent in New York on Tuesday.
Further recommended reading: Forbes: A Top Cardiologist Says a Diet Drug Maker Misled Patients and Investors
Filed Under: Drug Discovery