Santarus Announces Positive Results From Pivotal PK/PD Trials of Zegerid

Santarus has announced that the primary objectives were met in its pivotal pharmacokinetic/pharmacodynamic (PK/PD) clinical trials evaluating Zegerid chewable tablets, 20 mg and 40 mg.

Following final analysis of the clinical trial data and collection and analysis of the stability data, the company plans to file a new drug application under Section 505(b)(2) of the Federal, Food, Drug, and Cosmetic Act with the FDA during the second half of 2005, seeking U.S. marketing approval for Zegerid (omeprazole) chewable tablets.

The Zegerid products are immediate-release formulations of the proton pump inhibitor omeprazole.