(By Balachander) Cornerstone Therapeutics Inc. (NASDAQ:CRTX) said an advisory committee of the U.S. Food and Drug Administration (FDA) voted against the approval of the company's new drug application (NDA) for lixivaptan for the treatment of hyponatremia, a metabolic condition that occurs when there is not enough sodium (salt) in the blood.
Hyponatremia is is often diagnosed in patients with heart failure and affects up to six million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually.
In March, the Cary, North Carolina-based company announced the FDA's acceptance of its NDA for lixivaptan. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) 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 endpoint of serum sodium correction," said Craig Collard, Cornerstone's Chief Executive Officer.
According to Cornerstone, 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.
On Thursday, shares tumbled 35.24 percent to trade at $4.19. Over the past year, the stock has been trading in the range of $3.10 to $7.99.