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 Clinician’s 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 consumer’s 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
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