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Positive Results Announced from Pharmacokinetic Studies of Chewable Omeprazole
In October 2004, Santarus launched ZEGERID (omeprazole) Powder for Oral Suspension 20 mg, which received FDA approval in June 2004. The company received FDA approval of ZEGERID (omeprazole) Powder for Oral Suspension 40 mg in December 2004 and is planning to launch the 40 mg product later in the first quarter of 2005. Santarus announced positive results from pivotal PK/PD clinical trials for ZEGERID (omeprazole) Capsules 20 mg and 40 mg in November 2004 and plans to file an NDA for the 20 mg and 40 mg Capsules in the third quarter of 2005.
"Throughout the past year, we have continued to successfully achieve our clinical development and regulatory milestones. We received two NDA approvals in 2004 for ZEGERID Powder for Oral Suspension and completed pivotal trials on ZEGERID Capsules 20 mg and 40 mg. With the completion of our pivotal trials for ZEGERID Chewable Tablets 20 mg and 40 mg, we are able to move a third product closer to commercialization," said Gerald T. Proehl, president and chief executive officer of Santarus. "We are very pleased with the continued progress of our ZEGERID family of products."
Preliminary Data from ZEGERID Chewable Tablets Trials
The pivotal PK/PD clinical trials evaluating ZEGERID Chewable Tablets 20 mg and 40 mg were open-label, randomized, crossover trials, each conducted at a single site. Each trial evaluated the pharmacokinetics and pharmacodynamics of single doses and seven consecutive daily doses of ZEGERID Chewable Tablets compared to delayed-release omeprazole capsules in 36 healthy subjects. The primary objective of the trials was to evaluate whether the immediate-release ZEGERID Chewable Tablets were pharmacokinetically equivalent to delayed-release omeprazole capsules with respect to total systemic bioavailability (AUC) on Day 7. The trials also assessed whether ZEGERID Chewable Tablets and the delayed-release omeprazole capsules had similar ability to suppress gastric acidity over 24 hours. The preliminary trial results demonstrated that ZEGERID Chewable Tablets and the delayed-release omeprazole capsules were statistically equivalent with respect to AUC and percent decrease from baseline in integrated gastric acidity on Day 7.
As expected for an immediate-release product, the maximum plasma concentration (Cmax) was greater and the time to maximum plasma concentration (Tmax) was shorter on Day 7 for ZEGERID Chewable Tablets than for the delayed-release omeprazole capsules. These results are similar to those obtained in the pivotal PK/PD trials that were conducted for ZEGERID Powder for Oral Suspension 20 mg and 40 mg and ZEGERID Capsules 20 mg and 40 mg.
Source: Santarus, Inc.