A clinical trial to assess cardiovascular safety of obesity drug Contrave has been terminated. The trial of the drug developed by Orexigen Therapeutics Inc and Takeda Pharmaceutical Co Ltd was cancelled owing to the unauthorized release of study data.

Cleveland Clinic said that Orexigen has unofficially released the data in March compromising the study’s integrity. The company announced that the study has been terminated. Now, 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.

The news affected the shares of Orexigen, which fell 12% in after-market trading. On the other hand, Orexigen affirmed that they will defend their rights. The company also stated that they are looking into the assertions made by Takeda and also, said that they do not have any real value.

In March, Orexigen released confidential data from 25% of the study. It stated that the drug was better than placebo group. But when the next 25% data was released on Tuesday, it unveiled about 55 cases of heart attacks, strokes and cardiovascular deaths in patients taking Contrave when compared with 43 in the placebo group.

Steven Nissen, head of the study's executive steering committee, affirmed, “These (new) results do not confirm cardiovascular benefits of Contrave claimed by Orexigen in the patent application”.

On May 12, Takeda sent a dispute letter to Orexigen and seeks to end its collaboration agreement with the latter for material breach of the agreement. But spokeswoman Sandy Rodriguez said that Takeda is working with Orexigen in order to sort out the problem and to avoid the termination of the agreement.