FDA begins review of Cornerstone drug candidate

Cornerstone Therapeutics Inc. said Tuesday that the Food and Drug Administration will review its marketing application for a drug that treats low levels of sodium in the blood.

Cornerstone said the FDA will make a decision on the drug candidate CRTX 80 by Oct. 29. The drug is intended to treat hyponatremia, a condition caused by a lack of sodium. It is associated with heart failure, and Cornerstone said about a quarter of all heart failure patients develop the condition. Other causes can include burns, use of diuretic medications, kidney disease, and cirrhosis of the liver.

The Cary, N.C.-based company said about 6 million people in the U.S. have hyponatremia.

Shares of Cornerstone rose 43 cents, or 7.6 percent, to $6.10 in morning trading.

Cornerstone Therapeutics had $101 million in revenue in 2011. Its top-selling products include Curosurf, which treats respiratory distress syndrome in premature babies, and Zyflo asthma treatments.

USA Today