Regulatory Guidance

Clinical Trial Terminated After Contrave Data Leak

Source: Milwaukee Journal Sentinel

May 14, 2015

Orexigen Therapeutics and Takeda Pharmaceutical have pulled the plug on a large clinical trial that would have assessed the cardiovascular safety of weight loss drug Contrave, after Orexigen prematurely revealed data from the trial after it was about 25 percent complete.

Orexigen had released the early data from the 9,000 high-risk patient study as part of a patent application.

According to a release from the Cleveland Clinic, the FDA requested the initial 25 percent of study data when it approved Contrave in September 2014, but Orexigen proceeded to release those interim results to a wide group within the company and external business partners.

Takeda has initiated a formal dispute and has raised demands from Orexigen, including the entire cost of the new cardiovascular safety trial that will initiate later this year.

Read the Milwaukee Journal Sentinel article