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FDA Advisors Reject Lixivaptan for Hyponatremia

Final decision expected before October 29 (Sept. 13)

Cornerstone Therapeutics Inc., based in Cary, N.C., announced on September 13 that the Cardiovascular and Renal Drugs Advisory Committee of the FDA has recommended against approval of the company's new drug application (NDA) for lixivaptan (CRTX 080) for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and the syndrome of inappropriate antidiuretic hormone (SIADH), respectively.

In March 2012, Cornerstone announced the FDA's acceptance of the company's NDA for lixivaptan. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29, 2012.

The FDA will take the advisory committee's advice into consideration as part of its review of the NDA, but it is not bound by the committee's recommendations.

Hyponatremia is a metabolic condition that occurs when there is not enough sodium in the blood. It is the most common electrolyte disorder among hospitalized patients, affecting up to six million people in the U.S., and it is often diagnosed in patients with heart failure. Other causes of hyponatremia include burns, diuretic medications, kidney disease, liver cirrhosis, and SIADH. The disorder incurs direct medical costs estimated to range between $1.6 and $3.6 billion annually.

Lixivaptan is a nonpeptide, oral capsule that works by reducing the action of vasopressin, a hormone that blocks fluid excretion. Lixivaptan acts specifically on vasopressin-2 receptors in the kidneys, causing water to be excreted while sparing sodium and without affecting other electrolytes.

For more information, visit the Cornerstone Therapeutics Web site.

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