FDA's CRDAC recommends against approving lixivaptan

September 13, 2012

FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approving lixivaptan (CRTX 080, Cornerstone Therapeutics), for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.

FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) recommended against approving lixivaptan (CRTX 080, Cornerstone Therapeutics), for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.

In March 2012, Cornerstone announced FDA's acceptance of its NDA for lixivaptan. FDA has assigned a Prescription Drug User Fee Act goal date of October 29, 2012.

"While we respect the views of the CRDAC, we view today as another step in the process of bringing lixivaptan to market for patients with hyponatremia using the established surrogate end point of serum sodium correction," Craig A. Collard, Cornerstone's CEO, said in a company press release. "Cornerstone is committed to continuing to work with the FDA throughout the approval process building upon meeting our primary end point in each pivotal phase 3 trial."

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 and affects up to 6 million people in the United States, with direct medical costs estimated to range between $1.6 and $3.6 billion annually.

Lixivaptan is a highly potent, non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion. Lixivaptan acts specifically on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.