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PPT PPT Presentation Transcript

  • Zelnorm ® (tegaserod maleate) Advisory Committee Presentation Gastrointestinal Drugs July 14, 2004
  • Introduction John Cutt, PhD
    • Objectives of the Presentation
    • Proposed indication
    • Review Zelnorm ® Phase III clinical trial information
    • Review postmarketing safety data
  • Introduction (continued) John Cutt, PhD
    • Activity of tegaserod in GI tract
    • Clinical development program for chronic constipation
    • Zelnorm experience in clinical studies
    • Worldwide experience With Zelnorm
    • Conclusions
    • Agenda, speakers, and consultants
  • Unmet Need Charlene Prather, MD
    • Division of Gastroenterology and Hepatology
    • St. Louis University School of Medicine
    • External Presenter
  • Efficacy and Safety in Chronic Constipation Eslie Dennis, MD Novartis Senior Medical Director, Gastroenterology
    • Background
    • Tegaserod—Mechanism of action
    • Rationale for use of Zelnorm ® in the treatment of chronic constipation
    • Phase III chronic constipation studies
    • Pivotal Studies E2301, 2302
    • Study Objectives
  • Efficacy and Safety in Chronic Constipation (continued) Eslie Dennis, MD, Senior Medical Director
    • Studies E2301, E2301E, E2302
    • Study design
    • Inclusion and exclusion criteria
    • Patient disposition
    • Demographic information and constipation symptoms prior to treatment
  • Efficacy and Safety in Chronic Constipation (continued) Eslie Dennis, MD, Senior Medical Director
    • Results
    • Primary efficacy variable, responder = increase of > 1 CSBM, Wk 1-4
    • Secondary efficacy variable, responder = increase of > 1 CSBM, Wk 1-12
    • Weekly responder rate and complete spontaneous bowel movements
    • Further a priori secondary variables
      • Satisfaction with bowel habits, stool form, straining
  • Efficacy and Safety in Chronic Constipation (continued) Eslie Dennis, MD, Senior Medical Director
    • Additional analyses
      • Responder = ≥ 3 CSBM/wk during wk 1 – 4
      • Responder = ≥ 3 CSBM/wk during wk 1 - 12
      • Primary efficacy variable
        • Responders by baseline bowel movements per wk
        • Responders by subgroup
        • Patients without IBS-like features
    • Efficacy in chronic constipation— summary
  • Efficacy and Safety in Chronic Constipation (continued) Eslie Dennis, MD, Senior Medical Director
    • Safety in Chronic Constipation—12-wk safety profile
    • Exposure
    • Most frequent adverse events
    • Most frequent leading to discontinuation
    • Diarrhea
      • Evaluation and management
      • No clinically significant consequences
    • Serious adverse events
    • Laboratory evaluations
    • Summary of ECG abnormalities and QTc intervals
    • Abdominal and pelvic surgeries
  • Efficacy and Safety in Chronic Constipation (continued) Eslie Dennis, MD, Senior Medical Director
    • Long-term safety profile (16 months)
    • Studies E2301, E2301E1
    • Adverse events >5%
    • Conclusions
    • Proposed Indication
  • Safety Overview (continued) Bo Joelsson Head GI Clinical Research and Development
    • Safety data — CC sNDA versus IBS-C NDA
    • Summary of patients treated in clinical trials and postmarketing
    • Serious adverse events in overall clinical experience
  • Safety Overview (continued) Bo Joelsson Head GI Clinical Research and Development
    • Special Safety Topics
    • Experience in Clinical Trials and Postmarketing
    • Diarrhea
      • Serious consequences
    • Rectal bleeding
    • Ischemic colitis
    • Cholecystectomies
    • Biliary tract disorders
    • Ovarian disease
  • Safety Overview (continued) Bo Joelsson, Novartis, Head GI Clinical Research and Development
    • Safety profile of Zelnorm  supports the use in patients with chronic constipation
    • Overall safety conclusions
  • Benefit/Risk Philip Schoenfeld, MD, MSEd, MSc (Epi)
    • Assistant Professor of Medicine
    • University of Michigan School of Medicine
    • External presenter