Omeprazole Magnesium

6/28/02


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Table of Contents

Omeprazole Magnesium

Rx to OTC Switch

Target Population: People with Frequent Heartburn

Target Population Tries to Manage Frequent Heartburn

Current OTC Therapies Not Well-Suited for People with Frequent Heartburn

Omeprazole Ideally Suited for Target Population

Omeprazole Ideally Suited for Target Population

OTC Label

OTC Label Elements

OTC Label Elements

OTC Label Elements

OTC Label Elements

OTC Label Elements

PPT Slide

Presentation Agenda

Proposed Omeprazole RX to OTC Switch: A Clinicianís Perspective

Gap in OTC Therapy for Frequent Heartburn

Current Physician Experience With PPIs and Frequent Heartburn

OTC Omeprazole Consistent with Current Practice Guidelines

Frequent Heartburn Can Be Self-Managed With OTC Omeprazole

OTC Omeprazole Would Benefit Consumers

Efficacy and Consumer Use

Efficacy and Consumer Behavior Program

Efficacy Trials

Percent of Subjects Heartburn Free For 24 Hours: Time Course Over 14 Days

Conclusion: Efficacy Studies

Consumer Understanding and Behavior Program

Label Comprehension Study Design

Label Comprehension Study Results Who Should Use the Product

Label Comprehension Study Results Who Should Use the Product

Label Comprehension of Low Literate People with Frequent Heartburn

Subjects Understood How to Use the Product

Subjects Understood When Not to Use/Ask a Health Professional

Actual Use Study: Objectives

Actual Use Study Design

Study Phases

Disposition of Subjects

Demographics of Self-Selection Population

Results of Self-Selection

People Who Did Not Correctly Self- Select

Disposition of Subjects Who Purchased Product

Subjects Are Compliant With Dosing Directions

Compliance With the 14-Day Dosing Regimen

Compliance With the 14-Day Dosing Regimen

Return of Frequent Heartburn Four Weeks After Trial

Actual Use Study: Conclusions

Summary

Our proposed label, the efficacy data and the consumerís ability to understand and use this product safely and appropriately are congruent

OTC Omeprazole Update on Safety

OTC Omeprazole Product Safety

OTC Omeprazole Product Safety

Long-term Safety Issues Not Directly Related to the Product

Long-term Safety Issues Not Directly Related to the Product

Long-term Safety Issues Not Directly Related to the Product

Long-term Safety Issues Not Directly Related to the Product

Long-term Safety Issues Not Directly Related to the Product

Heartburn and Esophageal Cancer

Conclusions

Benefit/Risk Assessment of Omeprazole in the OTC Market

Considerations of Chronic Use of Omeprazole Without Physician Involvement

What Proportion of Consumers May Use OTC Omeprazole on a Regular Basis?

What Proportion of Consumers May Use OTC Omeprazole on a Regular Basis?

What Proportion of Consumers May Use OTC Omeprazole on a Regular Basis?

What Proportion of Consumers May Use OTC Omeprazole on a Regular Basis?

What Proportion of Consumers May Use OTC Omeprazole on a Regular Basis?

Considerations of OTC Chronic Use of Omeprazole Without Physician Involvement

Do Consumers With FHB Go to Their Physicians?

Do Consumers With FHB Go to Their Physicians?

Do Consumers With FHB Go to Their Physicians? Will OME Change That?

Do Consumers With FHB Go to Their Physicians? Will OME Change That?

Do Consumers With FHB Go to Their Physicians? Will OME Change That?

Do Consumers With FHB Go to Their Physicians? Will OME Change That?

Do Consumers With FHB Go to Their Physicians? Will OME Change That?

Do Consumers With FHB Go to Their Physicians? Will OME Change That?

Considerations of OTC Chronic Use of Omeprazole Without Physician Involvement

Considerations of OTC Chronic Use of Omeprazole Without Physician Involvement

Short-term PPI Superior to Long-Term H2RA for Healing of Esophagitis

Considerations of OTC Chronic Use of Omeprazole Without Physician Involvement

Summary

Conclusion

PPT Slide

Author: SEWP 3.0 Development User