FDA Reviewer Backs Lixivaptan for Hyponatremia
Panel recommendation due on Thursday (Sept. 11)
According to a September 11 report from Reuters, a clinical reviewer at the FDA has recommended that the agency approve lixivaptan, from Cornerstone Therapeutics, Inc., for the treatment of low sodium levels due to the syndrome of inappropriate antidiuretic hormone (SIADH), a condition that causes the body to have excess water.
The reviewer said, however, that the drug should not be approved for heart failure patients — another indication sought by the company.
An advisory panel of experts will vote on whether to recommend the drug to the FDA on Thursday, September 13.
Lixivaptan is a nonpeptide oral capsule that works by reducing the action of the hormone vasopressin, which blocks fluid excretion. Lixivaptan acts specifically on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium and without affecting other electrolytes.
For more information, visit the Reuters Web site.