OTC Omeprazole Magnesium (Prilosec 1TM)

10/25/00


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Table of Contents

OTC Omeprazole Magnesium (Prilosec 1TM)

Efficacy

Pharmacokinetics and Pharmacodynamics

Single-Dose Pharmacodynamic Study: Astra Merck Protocol 129 Intragastric pH vs.. time post-dose

Repeat Dose Pharmacodynamics Reference #44 (mean pentagastrin stimulated peak acid output- mmol H/hour

Heartburn Relief Trials:

Demographics of Studies 092/095

Primary Efficacy Endpoint: Sustained Complete Relief First Episode/First Dose

Secondary Endpoints First dose

Secondary Analysis “All Episodes Analysis”

Sustained Complete Relief “All Episodes” Separated by at Least 4 days

Additional Heartburn Relief Studies

Summary of Episodic Heartburn Relief

Prevention of Meal-Induced Heartburn

Primary Efficacy Endpoint Heartburn-Free:4 Hours Post Meal (% subjects heartburn-free)

Secondary Endpoints

Secondary Endpoints

Conclusions

Conclusions (cont.)

24-Hour Prevention Studies 171 and 183

Entry Criteria

Demographics

Primary Efficacy Endpoint Heartburn-Free Day 1 (% subjects)

Day 14 Heartburn-Free (% subjects)

Summary of Results

Time to Recurrence of Heartburn (% of Subjects Heartburn-Free Post-Treatment)

Conclusions: Daily Dose 24-Hour Prevention Studies

Prescription vs. OTC

Current Prescription Prilosec Label for GERD

What Is GERD?

Definitions of GERD

Definition of GERD (cont.)

Summary:Heartburn vs. GERD

Rationale for OTC Treatment of Episodic Heartburn

Current Template for OTC Acid Suppressive Agents for Heartburn

Proposed Prilosec 1 OTC label

Proposed Prilosec 1 OTC label (cont.)

Proposed Prilosec 1 OTC Label (cont.)

Overall Conclusions

Overall Conclusions (Cont)

Author: CDER USER