Please login to the form below

Not currently logged in
Email:
Password:

Cornerstone slumps as FDA panel votes down lead pipeline drug

US pharma company asked to conduct new trials for its hyponatremia treatment

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.

17th September 2012

From: Sales, Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Anatomy Health

We are a health information design consultancy focused on developing simple, accessible and inclusive patient communications. From evaluating existing patient...

Latest intelligence

Big data, privacy and the rise of genomic testing
Blue Latitude Health speaks to Johan Christiaanse, Marketing Director at BGI, to find out how the medical profession can overcome one of the major barriers to precision medicine – big...
Deal Watch January 2018
...
Emotional Intelligence and Blended Learning in Healthcare
EI and emotional selling are rising up the agenda when it comes to healthcare training. This article outlines how blended learning approaches can help put them into action....

Infographics