Santarus Inc, a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, has initiated a pivotal pharmacokinetic/pharmacodynamic (PK/PD) clinical trial to evaluate Zegerid 40mg Capsules, an immediate-release formulation of the proton pump inhibitor (PPI) omeprazole.
"Through our persistent development efforts, we continue to make progress toward our goal of providing physicians with a variety of new immediate-release omeprazole products and new treatment options for those patients who suffer from GI diseases and disorders," said Gerald T Proehl, president and chief executive officer of Santarus.
He added, "The start of the PK/PD clinical trial for Zegerid 40mg Capsules follows the initiation of a similar study for our capsule product at a 20mg dose. If these PK/PD trials are successful, we intend to file a New Drug Application (NDA) under Section 505(b)(2) of the Food, Drug, and Cosmetic Act seeking US marketing approval for both dose strengths of the capsule product, which is the regulatory strategy that we followed for our FDA-approved 20mg powder for oral suspension product."
The primary objective of this newly initiated clinical trial is to evaluate whether the 40mg immediate-release Zegerid (omeprazole) Capsules are pharmacokinetically equivalent to 40mg delayed-release omeprazole capsules with respect to total systemic bioavailability (AUC). The trial will also assess whether Zegerid Capsules and the delayed-release omeprazole capsules have similar ability to suppress gastric acid over 24 hours. If the Zegerid 40mg Capsules PK/PD clinical trial is successful, Santarus intends to seek approval for the treatment of gastric ulcers.
Santarus also plans to initiate pivotal PK/PD clinical trials later this year to evaluate its third immediate-release omeprazole product candidate, Zegerid Chewable Tablets in both 20mg and 40mg dose strengths.