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)
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