Table of Contents
A New Once-Daily Formulation of Isotretinoin Accutane NF
PPT Slide
Accutane Dose Efficacy Studies
Variability in Accutane Exposure
Accutane Dosing Issues
The New Formulation (NF) of Isotretinoin is as Safe and Efficacious as Accutane
PPT Slide
Clinical Development Program for NF
Clinical Study Objective
Daily Dosing Regimen
Inclusion Criteria
Clinical Efficacy Endpoints
Safety Evaluations During Trial
Additional Evaluations
Results - STD Efficacy Analyses
Overall Comparison of Safety
Adverse Events Leading to Treatment Discontinuation
Comparison of Total Adverse Events (ɱ%)
Lipid Profile During Treatment
Comparison of Psychiatric Events
Mucocutaneous Adverse Events (MAEs)
Mucocutaneous Event: Dry or Bleeding Nose
Mucocutaneous Event: Dry or Irritated Eyes
Isotretinoin / Hormonal Contraceptives Program
In Vitro Human Hepatocytes Experiments Experiment Completion Dates
Oral Contraceptive Clinical Studies
Oral Contraceptive Studies: Pharmacokinetic (PK) and Pharmacodynamic (PD) Assessments
Oral Contraceptive Studies Current Status
PPT Slide
Isotretinoin Dose Efficacy Studies
Plasma Concentrations of Isotretinoin After Single Dose of Accutane (80 mg), Accutane NF (30 mg) Under Fed or Fasted Conditions (n=74)
Effect of Food on Exposure
Effect of Food on Exposure (cont’d)
Method for Simulating the Steady State Plasma Concentrations of Isotretinoin
Figure 1 - Simulated Steady-State Exposure to Isotretinoin Following Administration of Accutane* & Accutane NF†
Simulated Steady State Exposure to Isotretinoin Following the Administration of Accutane and Accutane NF under Fed and Fasted Conditions
Isotretinoin Dose Efficacy Studies
AUC Exposure to Isotretinoin for Accutane and Accutane NF
PPT Slide
Risk of Confusion with Two Formulations
Simulated Steady State Exposure to Isotretinoin Following Administration of Accutane and Accutane NF Under Fed and Fasted Conditions
Simulated Steady State Exposure to Isotretinoin Following Administration of Accutane and Accutane NF Under Fed and Fasted Conditions
Simulated Steady-State Exposure to Isotretinoin Following Administration of Accutane (1.0 mg/kg) Given As Divided Doses & As a Single Daily Dose Compared With Accutane NF (0.4 mg/kg)
New Formulation Product Differentiation
The New Formulation of Isotretinoin is as Safe and Efficacious as Accutane
Labeling for the New Formulation
End of presentation
Benefit of New Formulation
PPT Slide
PPT Slide
PPT Slide
PPT Slide
Psychiatric Adverse Event Reports
Frequency Distribution of Triglycerides
Outcomes from Accutane Therapy
Accutane NF
Improved Safety Profile of Accutane NF Adverse Events
In Vitro Human Hepatocytes Program Experiment Completion Dates
Therapeutic Dose Range for Isotretinoin
Rationale for Evaluating Accutane NF
Psychiatric Adverse Event Reports
Simulated Steady State Exposure to Isotretinoin Following the Administration of Accutane and Accutane NF under Fed and Fasted Conditions
Simulated Steady State Exposure to Isotretinoin Following the Administration of Accutane and Accutane NF under Fed and Fasted Conditions
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