Shares of Orexigen Therapeutics Inc. tumbled after a safety study of the obesity drug Contrave was halted by researchers who said the pill didn’t show any benefit to the heart, contrary to previous claims.
After Tuesday’s disclosure, Orexigen stock fell 14 percent to close at $5.93, the largest single-day loss in 11 months. The trial was being run by the Cleveland Clinic, which released a statement with the updated results, showing the drug’s heart benefit disappeared as the trial progressed.
In March, La Jolla, California-based Orexigen released early data from the trial that appeared to show a reduction in heart-related deaths in patients taking the medicine.
The early release put Orexigen under scrutiny. Regulators at the Food and Drug Administration criticized the company, saying the trial’s integrity had been compromised and the company would have to run a second heart-safety test. Despite that, the shares gained the most in 18 months on the possibility that the drug could cut deaths as well as weight. Contrave was approved in September.
The heart benefit appears to have vanished now that the trial is halfway complete.
“These results do not confirm cardiovascular benefits of Contrave claimed by Orexigen,” said Steve Nissen, head of the trial’s executive steering committee and chairman of cardiovascular medicine at the Cleveland Clinic.
“The inconsistency of effects on cardiovascular outcomes between the first 25 percent and the second 25 percent of the Light Study clearly illustrates the risks inherent in pre-judgment of clinical trial results based upon an interim analysis and demonstrate why interim results should remain confidential during any ongoing trial,” he said in the statement.
Orexigen, in a statement Tuesday, said it was unable to comment on the data. The company said it hadn’t misled patients or investors by releasing the data in March.
Orexigen is partnered with Japan’s Takeda Pharmaceutical Co. on Contrave. Takeda has issued what Orexigen called a formal dispute process related to the March data disclosure.
“Takeda is seeking, among other things, Orexigen to pay the entire cost of the new cardiovascular outcomes trial,” Orexigen said in the statement.
Orexigen said that it believes Takeda’s claims are “without merit.” An e-mail and call to Takeda asking for comment wasn’t immediately returned.
In the first quarter of the trial, patients on Contrave had fewer major adverse cardiovascular events and cardiovascular deaths than patients on a placebo, Orexigen said in March. Conversely, in the next quarter of the trial, patients on Contrave had more events than the placebo group, the Cleveland Clinic said, eliminating the initial apparent benefit.
The Light Study was intended to assess cardiovascular safety of Contrave in overweight and obese patients. Since overweight patients are at higher risk for cardiovascular conditions, it’s important for obesity drugs to be safe for the heart.
“The Light Study is not being terminated due to a finding of superiority or harm,” Orexigen said in an earlier statement issued with Takeda Tuesday.