The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has recommended against the approval of Cornerstone Therapeutics’ new drug application (NDA) for lixivaptan (CRTX 080) for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.
In March 2012, the FDA accepted its NDA for lixivaptan. The FDA has assigned a Prescription Drug User Fee Act goal date of Oct. 29. Lixivaptan is a non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion, according to the Cary, N.C.-based Cornerstone. Lixivaptan acts on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.
"While we respect the views of the CRDAC, we view today as another step in the process of bringing lixivaptan to market for patients with hyponatremia using the established surrogate endpoint of serum sodium correction," said Craig A. Collard, Cornerstone's CEO. "Cornerstone is committed to continuing to work with the FDA throughout the approval process building upon meeting our primary endpoint in each pivotal Phase 3 trial."
The FDA takes the advisory committee's advice into consideration as part of its review of the NDA but is not bound by the committee's recommendations.