Table of Contents
Summary of Efficacy
Efficacy
Efficacy
Efficacy
Advantages of Home-Use Questionnaire vs. Retrospective Questionnaire (e.g., IIEF)
PPT Slide
Patient Population
Patient Population (cont.)
Definition of “No Major Organic Component”
Patient Demographics
Representative ED Patient Population
Major Subgroups
Baseline ED Severity Based on IIEF*
ED Population
Comparison of Uprima® NPT Values with Values for Normals
Comparison of Uprima® NPT Values with Values for Normals
Representative ED Patient Population Conclusion
Efficacy Endpoints
Efficacy Endpoints for Phase III Studies
Efficacy Endpoints for Phase III Studies
Uprima®-Efficacy Endpoints
Efficacy
Crossover Study Schematic
Crossover Studies
Patient Response (per attempt) “Erection Firm Enough for Intercourse”
Patient Response (per attempt) “Did Attempt Result in Intercourse”
Intercourse Rates Comparison of Uprima® to Viagra®
Partner Responses
Partner Involvement in Uprima® Studies
Partner Response (per attempt) “Erection Firm Enough for Intercourse”
Partner Response (per attempt) “Did Attempt Result in Intercourse”
Primary Endpoint Subgroup Analyses
Patient Response (per attempt) “Erection Firm Enough for Intercourse”
Patient Response (per attempt) “Erection Firm Enough for Intercourse”
ED Severity
Assessment of Effect of ED Severity on Efficacy
Definition of ED Severity Based on IIEF
Patient Response (per attempt) “Erection Firm Enough for Intercourse”
Patient Response (per attempt) “Erection Firm Enough for Intercourse”
Patient Response (per attempt) “Erection Firm Enough for Intercourse”
ED Severity Conclusion
Other Endpoints
Other Endpoints
Median Time to Erection (Using Only Attempts When an Erection Was Achieved)
Patient Assessment Percentage of Patients Deemed a Treatment Success
Percent of Patients with Mean Intercourse Attempt Satisfaction ɯ and an Improvement Over Baseline
Percent of Partners with Mean Intercourse Attempt Satisfaction ɯ and an Improvement Over Baseline
Percent of Patients with 4 Point Improvement in the Erectile Function Domain Index of the IIEF
Phase III Crossover Studies Conclusion
Phase III Crossover Studies Conclusion (cont.)
Efficacy
PPT Slide
Diabetes Study Baseline ED Severity
Patient Response (per attempt) “Did You Achieve an Erection Firm Enough for Intercourse”
Patient Response (per attempt) “Erection Firm Enough for Intercourse”
Diabetes Efficacy Conclusion
Uprima® Efficacy
Parallel Study Schematic Design
Patient Response (per attempt) “Erections Firm Enough for Intercourse”
Partner Response (per attempt) “Erections Firm Enough for Intercourse”
Patient Response (per attempt) “Did Attempt Result in Intercourse”
Efficacy
Discontinuations in Long-Term Studies
Long-Term Studies
Percentage of Erections Firm Enough for Intercourse
Long-Term Studies
Percentage of Erections Firm Enough for Intercourse
Percentage of Erections Firm Enough for Intercourse
Efficacy in Long-Term Studies Conclusion
Overall Efficacy Conclusions
Overall Efficacy Conclusions
Overall Efficacy Conclusions (cont.)
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