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What's Next For Cornerstone Therapeutics?

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A little over a month remains for Cornerstone Therapeutics Inc. (CRTX) to know whether or not its investigational drug, Lixivaptan, gets green light from an FDA advisory panel for the proposed treatment of hyponatremia.

Hyponatremia, a condition that occurs when there is not enough sodium (salt) in the blood, is commonly seen among hospitalized patients, affecting up to six million people in the U.S. Though often diagnosed in patients with heart failure, hyponatremia can also be caused by burns, diuretic medications, kidney disease, liver cirrhosis and syndrome of inappropriate antidiuretic hormone.

Lixivaptan (CRTX 080) came into Cornerstone's fold when it acquired privately held Cardiokine Biopharma last December. The compound is said to work by acting specifically on a hormone - vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.

The New Drug Application for Lixivaptan in the proposed indication of hyponatremia was filed with the FDA late last December. The Lixivaptan NDA was accepted for review by the regulatory agency in March of this year with a decision date set for October 29, 2012.

Before the FDA makes a final decision on Lixivaptan, the Cardiovascular and Renal Drugs Advisory Committee of the FDA is scheduled to meet on September 13, 2012 to vote on whether or not to recommend approval for the drug for the proposed indication. The FDA is not required to follow the panel's advice, though it often does.

Cornerstone Therapeutics is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related specialty markets. The company markets products like Curosurf, a hospital-administered treatment for respiratory distress syndrome in premature babies, asthma drug Zyflo CR, and approved generic products primarily to large national wholesalers, which in turn resell the products to smaller or regional wholesalers, hospitals, retail pharmacies, chain drug stores, government agencies and other third parties.

In March 2012, the company sold the anti-infective product lines, Factive and Spectracef, to Merus Labs International Inc. and Vansen Pharma Inc., respectively, in exchange for cash consideration and the assumption of certain product-related liabilities.

As recently as June of this year, Cornerstone Therapeutics acquired EKR Therapeutics Inc., a privately-held specialty pharmaceutical company, expanding its hospital product portfolio with cardiovascular products namely CARDENE I.V. and RETAVASE. The company expects to relaunch RETAVASE in 2013.

The company is scheduled to report its second quarter financial results on August 9, before the market opens.

Shares of Cornerstone Therapeutics have thus far hit a low of $4.45 and a high of $8.60. The stock closed Thursday's trading at $7.10, up 0.42%, on a volume of 118,200 shares.

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