FDA spurns new low-sodium drug from Cornerstone

Cornerstone Therapeutics ($CRTX) may not have landed quite the deal it thought it had when it bought Cardiokine and its late-stage drug lixivaptan for a mere $1 million down. After getting shot down by a panel of outside experts, the biotech reported this morning that the agency had formally rejected its application for the low-sodium therapy, demanding a new set of "clinical and non-clinical information" before it could reconsider an approval. 

Cornerstone shares only dropped a bit more than 10% this morning, a sign of the general expectation that the biotech was fighting a losing battle.

Cornerstone didn't even try to detail exactly what the FDA said in its CRL, instead insisting that it already had the data to demonstrate its efficacy against hyponatremia, a condition characterized by low sodium levels in the blood which can trigger excess water levels and some severe physical reactions which can be potentially fatal. Six million Americans suffer from the ailment, which is linked to congestive heart failure and erratic chemical syndromes.

"We are reviewing the Complete Response Letter and will determine the most appropriate next steps for the lixivaptan program," said Craig A. Collard, Cornerstone's CEO. "We believe we have strong clinical data supporting lixivaptan for the treatment of hyponatremia and that a significant unmet need remains for an alternative vaptan in the hospital and community setting."

Agency officials likely agreed with the panel's recommendation, which urged that the company come up with more trial data that could better determine whether the modest benefits of the drug outweighed some distinct risks. In the pivotal study, the drug arm experienced a higher risk of death, though there was never a direct link made with lixivaptan. 

- here's the press release

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