CLARITINŽ (10 mg loratadine) OTC Indication for Chronic Idiopathic Urticaria

5/14/02


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Table of Contents

CLARITINŽ (10 mg loratadine) OTC Indication for Chronic Idiopathic Urticaria

Background

Objective

Agenda

CIU as an OTC Indication

Findings

Findings

URTICARIA (Hives)

Objectives of Presentation

PPT Slide

Differentiating Acute from Chronic Urticaria (Hives)

Potential Causes of Urticaria (Hives)

Diagnosing Chronic Idiopathic Urticaria (Chronic Hives of Unknown Cause)

Management of Acute Urticaria (Hives)

Management of Chronic Idiopathic Urticaria

Treatment Algorithm for Chronic Idiopathic Urticaria

Spectrum of Urticaria Patients

Most Likely Conditions Confused or Misdiagnosed for CIU

Consequences of Misdiagnosis

Consequences of Misdiagnosis

Consequences of Misdiagnosis

Consequences of Misdiagnosis

Anaphylaxis

Anaphylaxis (cont.)

Conclusions

Chronic Idiopathic Urticaria: Key Studies Conducted By Schering-Plough

Schering Conducted Four Studies

Consumer Study Design

Consumer Study Design

Consumer Study Design

Q. In a typical year, how many episodes of chronic hives do you experience?

Frequency of Suffering

Q. Please indicate the symptoms you experience when your hives recur.

PPT Slide

Q. Thinking about when the hives appeared prior to seeing a physician, what, if anything, did you do to treat or relieve the condition?

Action at Initial Occurrence

Q. In the past year, how often have you seen a physician for this condition?

Physician Care

Q. When your chronic hives recur, please indicate what you normally do?

Typical Action Upon Recurrence

Physician Contact

Q. Now that your condition has been diagnosed by a physician, how easy is it for you to identify this condition when it reappears?

Ability to Self-Recognize CIU

Q. What would you do if you experienced other symptoms such as difficulty breathing, fever or trouble swallowing with your hives?

Presence of Serious Symptoms

Conclusions: Consumer Study

Physician Practices Study Design

Physician Practices Study Design

Q. What terminology do you typically use when explaining the initial diagnosis to your patients?

Nomenclature Used To Describe CIU

Q. After receiving a diagnosis of chronic idiopathic urticaria from a physician, how likely do you feel a sufferer is able to self-identify or recognize recurrent episodes of this condition?

Likelihood of Recognizing Recurrent Episodes

Q. Thinking of all the patients you have counseled for chronic idiopathic urticaria what percentage do you recommend keep medicine on hand in anticipation of a recurrent episode ?

Physician Encouraged Self-Management Practices

Conclusions: Physician Practices Study

Self Recognition Study

Self Recognition Study

Confirmed Self-Recognition

Conclusions: Self-Recognition Study

Label Comprehension Study

Label Comprehension Study

Label Comprehension Study

Label Comprehension Study

Label Comprehension

Label Comprehension

Conclusions: Label Comprehension Study

Conclusions: Label Comprehension Study

Risk/Benefit of ClaritinŽ OTC

ClaritinŽ Marketing History

ClaritinŽ Patient Exposure

ClaritinŽ Safety

Poison Center Data on Loratadine

ClaritinŽ OTC Examples of Labeled Indications

OTC Marketing Experience Canada and United Kingdom

ClaritinŽ Safety--Conclusion

Risk/Benefit Conclusions

ClaritinŽ OTC Consumer and Health Professional Education Program

ClaritinŽ OTC Consumer and Health Professional Education Program

Response to FDA Questions

PPT Slide

Conclusions

Advisory Committee Questions

Advisory Committee Questions

Advisory Committee Questions

BACK PANEL

Recommendation

Author: Schering Plough