A hyponatremia treatment from Cornerstone Therapeutics (NASDAQ:CRTX) is now targeted for a regulatory approval decision in the fourth quarter.

The U.S. Food and Drug Administration has accepted the new drug application for the compound CRTX 080. The agency set a goal date of a Prescription Drug User Fee Act (PDUFA) date of October 29 to decide whether to approve the cardiovascular drug. CRTX 080 is a compound that Cary-based Cornerstone brought into its drug pipeline with its acquisition late last year of Cardiokine Biopharma.

Hyponatremia is a condition in which the blood’s sodium levels are abnormally low. The condition is commonly diagnosed in patients with heart failure. Cornerstone said that hyponatremia affects up to six million people in the United States costing between $1.6 billion and $3.6 billion in direct medical costs. CRTX 080 works by targeting the vasopressin-2 receptor in the kidneys, which causes water to be excreted. The compound spares sodium without affecting other electrolytes.

The drug is an important part of Cornerstone’s strategy to emphasize products used in hospitals. Last year, Cornerstone announced it would move away from its anti-infectives business because of its vulnerability to generic competition. Instead, the company would focus on hospital-based products. Infant respiratory treatment Curosurf, Cornerstone’s top-selling product with $34.8 million in 2011 sales, is a hospital-based product. CRTX 080 would add another product to Cornerstone’s hospital products portfolio.

“The hyponatremia market increased 86 percent in 2011, and we look forward to launching CRTX 080 into this rapidly expanding market,” Collard said in a statement.

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