Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has accepted for filing ZS Pharma's new drug application (NDA) for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalemia.
Subscribe to our email newsletter
ZS-9 is an insoluble, non-absorbed zirconium silicate with a three-dimensional crystalline lattice structure that was designed to preferentially trap potassium ions.
The potassium selectivity of ZS-9 allows high in-vitro binding capacity for potassium ions even in the presence of other competing ions.
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is 26 May 2016.
ZS Pharma chief executive officer Robert Alexander said: "Hyperkalemia is a serious condition with few treatment options and ZS-9 could be the first selective agent approved for the treatment of this condition.
"The acceptance of the NDA is an important step toward making ZS-9 potentially available to patients with hyperkalemia."
The company has examined ZS-9 in three double-blind, placebo controlled trials and in two ongoing 12 month open label studies in patients with hyperkalemia which represents more than 1,600 patients treated with ZS-9.
According to the company, its investigational product ‘ZS-9’ has not been approved for any indication in any market.