(Cary, N.C.) Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets, announced today the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) recommended against the 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 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 has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29, 2012. The FDA takes the advisory committee’s advice into consideration as part of its review of the NDA but is not bound by the committee’s recommendations.
“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 A. Collard, Cornerstone’s Chief Executive Officer. “Cornerstone is committed to continuing to work with the FDA throughout the approval process building upon meeting our primary endpoint in each pivotal Phase 3 trial.”
Hyponatremia 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. 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.
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. In the U.S. alone, there are five million heart failure patients, and each year one-fourth of them develop hyponatremia. Other causes of hyponatremia include burns, diuretic medications, kidney disease, liver cirrhosis and syndrome of inappropriate antidiuretic hormone (SIADH).
About Cornerstone Therapeutics
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related specialty markets. Key elements of the Company’s strategy are to focus its commercial and development efforts in the hospital and related specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies and marketed and/or registration-stage products that fit within the Company’s focus areas; and generate revenues by marketing approved generic products through the Company’s wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit www.crtx.com.