Clinical Overview Omeprazole Magnesium (Prilosec 1 TM) June 21, 2002

6/25/02


Click here to start


Table of Contents

Clinical Overview Omeprazole Magnesium (Prilosec 1 TM) June 21, 2002

Initial Proposed Indications for OTC Omeprazole Mg

Conclusions of First Advisory Committee

Pharmacological Characteristics of Omeprazole-Mg

The increase of acid suppression over consecutive daily doses may reinforce continuous unsupervised usage by consumers seeking optimal relief of chronic heartburn

Overview of Presentation

Omeprazole-Mg Safety Profile Toxicity of Short-Term Exposure

Drug-Drug Interactions

Safety Issues of Long-term OTC Exposure

Potential for Long-term OTC Usage

Currently Proposed Indications

Efficacy Studies

Study Results

Influence of Baseline Heartburn Frequency on Responses

Conclusions

GERD*

Characterization of Study Patients

Actual Use Study

Cautions Listed in Proposed Labeling

Issues to Resolve

Author: Mark Avigan