CARY, N.C. – Cornerstone Therapeutics Inc. (NASDAQ: CRTX) said Friday that the U.S. Food and Drug Administration (FDA) has scheduled a review of its new drug application for lixivaptan.
According the company, the product is being proposed for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively.
Hyponatremia is a metabolic condition that occurs when there is not enough sodium (salt) in the blood. It is the most common electrolyte disorder among hospitalized patients affecting up to six million people in the U.S. and is often diagnosed in patients with heart failure.
The meeting with the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the FDA is scheduled for Sept. 13.
“Hyponatremia is a very common and complex condition, and we are committed to bringing lixivaptan to the market,” said Craig A. Collard, Cornerstone’s Chief Executive Officer.
Cornerstone acquired lixivaptan through its 2011 acquisition of Cardiokine Biopharma, which became a wholly-owned subsidiary of Cornerstone.
Hyponatremia’s estimated direct medical costs 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.
Cornerstone Therapeutics is headquartered in Cary.