Table of Contents
NDA 21-272 Remodulin™ (treprostinil sodium) Injection
Presentation and Speakers
Additional Representatives for Treprostinil
Pulmonary Arterial Hypertension
Symptoms of PAH
Commonly Used Treatments for PAH
Epoprostenol
Treprostinil Sodium
Development Rationale
Epoprostenol Delivery System
Treprostinil Delivery System
Epoprostenol vs. Treprostinil
Clinical Development
Pilot Study P01:03 Efficacy Results - Change from Baseline
P01:04 and P01:05 International, Multicenter, Double-Blind, Placebo-Controlled Trial Program (40 Centers)
Entry Criteria
Study Design
Efficacy Measures
6-Minute Walk Test
Symptoms and Signs
Symptoms and Signs
Dyspnea-Fatigue Rating
Dyspnea Fatigue Rating Magnitude of Task
Hemodynamic Measurements
Quality of Life (Minnesota Questionnaire)
Prespecified Endpoints
Statistical Analysis
Pre-specified Primary Analysis Plan
Baseline Characteristics Study 04/05
Baseline Characteristics Study 04/05
Baseline Hemodynamics Study 04/05
Baseline Treatment Study 04/05
Dosing Principles Study 04/05
PPT Slide
Effect of Treprostinil on 6-Minute Walk Distance at Weeks 1, 6, 12 (Placebo-Corrected; Study 04/05)
Change in 6-Minute Walk Distance Week 12
PPT Slide
PPT Slide
Time to Initiation of epoprostenol Discontinuation due to AE vs Deterioration Since discontinuation
Survival Distribution Since Discontinuation
PPT Slide
PPT Slide
PPT Slide
Distribution of Exercise Responses at Week 12 Study 04/05
Influence of Baseline Walk on 6-Minute Walk Distance at Week 12 Study 04/05
Influence of NYHA Class on 6-Minute Walk Distance Study 04/05
Severity of Dyspnea During Exercise Borg Dyspnea Score
Effect of Treprostinil on Distance and Symptoms During 6-Minute Walk Test (Placebo-Corrected, Study 04/05)
Cumulative Frequency Distribution Analysis of Distance and Symptoms During 6-Minute Walk Test (Study 04/05, Week 1)
Cumulative Frequency Distribution Analysis of Distance and Symptoms During 6-Minute Walk Test (Study 04/05, Week 6)
Cumulative Frequency Distribution Analysis of Distance and Symptoms During 6-Minute Walk Test (Study 04/05, Week 12)
PPT Slide
Signs and Symptoms of PAH Composite Score
Individual Symptoms Any Time During Double-Blind Therapy Compared With 4 Weeks Prior to Randomization
Individual Symptoms Last 6 Weeks of Double-Blind Therapy Compared With 4 Weeks Prior to Randomization
Syncope
Dyspnea Fatigue Score
Magnitude of Task Change from Baseline Percent of Patients Study 04/05
Patients Experiencing Clinical Deterioration (Prespecified Analysis) Study 04/05
Patients Experiencing Clinical Deterioration (Expanded Analysis) Study 04/05
Hospitalizations Study 04/05
Hemodynamic Effect Week 12 Study 04/05
Quality of Life (Minnesota Scale) Study 04/05
PPT Slide
Long-term Effects on 6-minute Walk (Study P01:06)
Efficacy Conclusions
Treprostinil Safety Experience/Exposure
Duration of Exposure (As of Oct. 1, 2000)
Doses of Treprostinil Used During Long-term Treatment
Adverse Events Reported by ᡂ% of Patients
Adverse Events Reported by ᡂ% of Patients
Adverse Events Reported by ᡂ% of Patients
Adverse Events by Dose at First Onset
Adverse Events by Duration of Treatment
Serious Adverse Events
Adverse Events Leading to Discontinuation
Local Infusion Site Pain and Reaction
Infusion Site Treatments Prescribed to ᡌ% Patients Study 04/05
Prescribing of Narcotic Analgesics
Infusion Site Pain Treatment Prescribed Narcotic Analgesics
Use of Narcotic Analgesics Study 06 Survey (535 of 545 patients)
Other Safety Considerations
PPT Slide
Risks of Epoprostenol Therapy
Treprostinil
Benefits of Treprostinil
Relation of Benefits to Risks of Treprostinil
PPT Slide
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