US Panel Rejects Lixivaptan for Hyponatremia

September 14, 2012

WASHINGTON (Reuters) Sep 13 - Cornerstone Therapeutics Inc failed to win a U.S. advisory panel's support on Thursday for a drug that treats hyponatremia.

The panel of outside advisers to the Food and Drug Administration voted five to three to recommend rejection of lixivaptan for treating hyponatremia due to syndrome of inappropriate antidiuretic hormone (SIADH). They also unanimously voted against using the drug to treat low sodium in heart failure patients.

The FDA usually follows panel recommendations, but it is not required to. A final decision is expected by October 29.

Most panel members said the drug's risks outweighed its modest benefit in raising sodium levels, and called for more trials to make sure it was safe.

In a clinical trial in heart failure patients, lixivaptan was linked to more deaths compared to placebo -- though it was uncertain whether the drug actually caused the deaths.

Panel member Dr. Vasilios Papademetriou, a cardiologist at the Veterans Affairs Medical Center in Washington, D.C., said he wants to treat his patients with drugs that either improve their symptoms or help them live longer.

"This drug in these studies has shown neither," he said at the meeting, monitored via a webcast. "So I don't think that there is enough for me to consider this medication as essential or necessary in the market."