Santarus submits application for Zegerid capsules

The company is seeking marketing approval of Zegerid capsules as the first immediate-release proton pump inhibitor (PPI) in a capsule formulation for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers and gastric ulcers.

Santarus has been marketing the product in powder form since 2004. This method of ingestion also allows immediate-release PPI product and provides rapid absorption of the drug (reaching peak plasma levels in approximately 30 minutes) and strong 24-hour acid control with once-a-day dosing. Santarus is currently developing a chewable form of the product.

President and CEO of Santarus, Gerald Proehl, believes that by introducing the product in a capsule form the company will be able to reach a broader target population. Mr Proehl said: “We believe the commercial availability of our capsule product will broaden Zegerid usage, as capsules may be more convenient for patients taking Zegerid on a chronic basis.”

Mr Proehl was keen to emphasize the company’s continued development of the product; “We continue to move forward on the Zegerid chewable tablets NDA (New Drug Application) submission, which we expect to complete in the third quarter of this year, bringing both our capsule and chewable tablet products closer to commercialization in the $12 billion US PPI prescription market.”