US pharma company Cornerstone Therapeutics suffered a setback after an FDA advisory committee voted against approval of lixivaptan, the firm’s drug candidate for hyponatremia or low sodium levels in the blood.
Cornerstone is trying to get approval for lixivaptan as a treatment for low blood sodium associated with heart failure (CHF) and a disorder known as syndrome of inappropriate antidiuretic hormone (SIADH), and looked to be on track after FDA reviewers published a document which seemed to support approval.
But after much discussion, the expert panel concluded that lixivaptan’s benefits in raising sodium levels were not sufficiently robust to offset the risks associated with treatment, and said additional clinical trials should be carried out to ensure the treatment was safe.
Lixivaptan works by blocking the activity of vasopressin, a hormone that blocks fluid secretion, and is designed to increase the loss of water from the body whilst conserving sodium. It was originally developed by Wyeth and subsequently acquired by Cardiokine, which was bought by Cornerstone earlier this year.
Trading in Cornerstone shares was suspended ahead of the advisory committee meeting when they were a little under $6.50 and they then fell to $4.24 once trading resumed, although they have since staged something of a recovery and are currently a little over $5.
“We view [the panel vote] 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 Cornerstone’s chief executive Craig Collard, who noted that the drug head reached its endpoints in each of its phase III trials.
Hyponatremia costs the US health system $1.6bn to $3.6bn a year, according to the company, and is the most common electrolyte disorder among hospitalised patients affecting up to six million people, often seen in those diagnosed with CHF.
The FDA has until October 29 to deliver its verdict on the application, but generally does not overrule its advisory committees.