Federal reviewer recommends pharmaceutical sales of Cornerstone’s low salt drug

Posted on Sep 19, 2012 in Uncategorized

Be sure to listen to Medical Rewind with Dr. Rashid Buttar and Robert Scott Bell as they discuss the article below in detail.   www.medicalrewind.com   Listen to the Monday, September 17th show.


 If you have low sodium, do you need more sodium – or a new drug?

Federal reviewer recommends pharmaceutical sales of Cornerstone’s low salt drug

Pharmaceutical sales recruiters are keeping a close eye on Cornerstone Therapeutics after a clinical reviewer recommended that the Food and Drug Administration (FDA) approve the company’s new low salt drug, lixivaptan.Reuters reports that the review by Dr. Nancy Xu comes ahead of a meeting of a full panel of outside experts, which will take a vote on whether the drug should be approved for commercialization by the federal agency to treat hyponatremia, a condition that could lead to respiratory arrest and death.

“Hyponatremia is a very common and complex condition, and we are committed to bringing lixivaptan to the market,” Craig A. Collard, Cornerstone’s chief executive officer, said in a press release earlier this year. “Our team looks forward to discussing the data supporting the potential efficacy benefit and safety profile of lixivaptan with the committee and the FDA.”

While the news sent shares of Cornerstone’s stock up more than 5 percent in early trading, Xu said lixivaptan should not be approved for heart failure, which the North Carolina-based company had also sought, according to the news source.

According to the company, hyponatremia affects approximately 6 million Americans. Cornerstone said the FDA expects to review lixivaptan by October 29.