The new formulation is a swallowable tablet that combines immediate-release omeprazole, a proton pump inhibitor, with a mix of buffers. Santarus plans to undertake clinical and stability studies with the tablet in preparation for the submission of a new drug application to the FDA. The company’s objective is to have the new Zegerid tablet product commercially available in the US in the second half of 2009.
Gerald Proehl, president and CEO of Santarus, said: “We have a successful track record of moving quickly through product and clinical development to regulatory approval for Zegerid capsules and powder for oral suspension. We are focused on achieving similar results for this new Zegerid formulation so we can expand the Zegerid family of product offerings.”