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203697Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 203697Orig1s000 MEDICAL REVIEW(S) Clinical Review Linda Hu NDA 203697 Aspirin capsules CLINICAL REVIEW Application Type NDA Application Number(s) 203697 Priority or Standard Standard Submit Date(s) March 12, 2012 Received Date(s) March 14, 2012 PDUFA Goal Date January 14, 2013 Division / Office DNCE/ODE IV Reviewer Name(s) Linda Hu Review Completion Date December 10, 2012 Established Name Aspirin (b) (4) (Proposed) Trade Name Therapeutic Class Analgesic, antipyretic Formulation(s) Capsule, liquid filled Dosing Regimen 1 or 2 capsules every 4 hours or 3 capsules every 6 hours ; do not exceed 12 capsules in 24 hours Indication(s) For temporary relief of minor aches and pains due to headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, premenstrual and menstrual cramps; Temporarily reduces fever Intended Population(s) Adults; Children 12 years and over 1 Reference ID: 3228196 Clinical Review Linda Hu NDA 203697 Aspirin capsules Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 6 1.1 Recommendation on Regulatory Action ............................................................. 6 1.2 Risk Benefit Assessment.................................................................................... 6 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ... 9 1.4 Recommendations for Postmarket Requirements and Commitments ................ 9 2 INTRODUCTION AND REGULATORY BACKGROUND ...................................... 10 2.1 Product Information .......................................................................................... 10 2.2 Tables of Currently Available Treatments for Proposed Indications ................. 10 2.3 Availability of Proposed Active Ingredient in the United States ........................ 11 2.4 Important Safety Issues with Consideration to Related Drugs.......................... 11 2.5 Summary of Presubmission Regulatory Activity Related to Submission .......... 11 2.6 Other Relevant Background Information .......................................................... 14 3 ETHICS AND GOOD CLINICAL PRACTICES....................................................... 14 3.1 Submission Quality and Integrity ...................................................................... 14 3.2 Compliance with Good Clinical Practices ......................................................... 14 3.3 Financial Disclosures........................................................................................ 14 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES ......................................................................................................... 15 4.1 Chemistry Manufacturing and Controls ............................................................ 15 4.2 Clinical Microbiology......................................................................................... 16 4.3 Preclinical Pharmacology/Toxicology ............................................................... 16 4.4 Clinical Pharmacology...................................................................................... 17 4.4.1 Mechanism of Action.................................................................................. 17 4.4.2 Pharmacodynamics.................................................................................... 18 4.4.3 Pharmacokinetics....................................................................................... 18 5 SOURCES OF CLINICAL DATA............................................................................ 20 5.1 Tables of Studies/Clinical Trials ....................................................................... 20 5.2 Review Strategy ............................................................................................... 21 5.3 Discussion of Individual Studies/Clinical Trials................................................. 22 6 REVIEW OF EFFICACY......................................................................................... 42 Efficacy Summary...................................................................................................... 42 7 REVIEW OF SAFETY............................................................................................. 42 Safety Summary ........................................................................................................ 42 7.1 Methods............................................................................................................ 43 7.1.1 Studies/Clinical Trials Used to Evaluate Safety ......................................... 43 7.1.2 Categorization of Adverse Events.............................................................. 44 2 Reference ID: 3228196 Clinical Review Linda Hu NDA 203697 Aspirin capsules 7.1.3 Pooling of Data Across Studies/Clinical Trials to Estimate and Compare Incidence.................................................................................................... 44 7.2 Adequacy of Safety Assessments .................................................................... 44 7.2.1 Overall Exposure at Appropriate Doses/Durations and Demographics of Target Populations..................................................................................... 44 7.2.2 Explorations for Dose Response................................................................ 44 7.2.3 Special Animal and/or In Vitro Testing ....................................................... 44 7.2.4 Routine Clinical Testing ............................................................................. 44 7.2.5 Metabolic, Clearance, and Interaction Workup .......................................... 45 7.2.6 Evaluation for Potential Adverse Events for Similar Drugs in Drug Class .. 45 7.3 Major Safety Results ........................................................................................ 45 7.3.1 Deaths........................................................................................................ 45 7.3.2 Nonfatal Serious Adverse Events .............................................................. 45 7.3.3 Dropouts and/or Discontinuations .............................................................. 45 7.3.4 Significant Adverse Events ........................................................................ 45 7.4 Supportive Safety Results ................................................................................ 46 7.4.1 Common Adverse Events .......................................................................... 46 7.4.2 Laboratory Findings ................................................................................... 47 7.4.3 Vital Signs .................................................................................................. 47 7.4.4 Electrocardiograms (ECGs) ....................................................................... 48 7.4.5 Special Safety Studies/Clinical Trials......................................................... 48 7.4.6 Immunogenicity.......................................................................................... 48 7.5 Other Safety Explorations................................................................................. 48 7.6 Additional Safety Evaluations ........................................................................... 48 7.6.3 Pediatrics and Assessment of Effects on Growth ...................................... 48 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound...................... 49 7.7 Additional Submissions / Safety Issues............................................................ 49 8 POSTMARKET EXPERIENCE............................................................................... 49 9 APPENDICES ........................................................................................................ 53 9.1 Literature Review/References .......................................................................... 53 9.2 Labeling Recommendations ............................................................................. 68 9.3 Advisory Committee Meeting............................................................................ 70 3 Reference ID: 3228196 Clinical Review Linda Hu NDA 203697 Aspirin capsules Table of Tables Table 1 Currently Available Drugs................................................................................. 10 Table 2: Inactive Ingredients in PL2200 Capsule .......................................................... 16 Table 3 Clinical Trials Submitted................................................................................... 20 Table 4 PL-ASA-001 Schedule ........................................................................................ 24 Table 5 PL-ASA-001 ...................................................................................................... 25 Table 6 Current BE analysis and analysis with OSI-recommended exclusion of subjects........ 27 Table 7 PL-ASA-002 Schedule ...................................................................................... 32 Table 8 Incidence of GI injury by Mucosal Injury Composite Score .............................. 36 Table 9 PL-ASA-003 Schedule ........................................................................................ 39 Table 10 Salicylic acid PK, fed vs. fasted, for PL2200 650 mg ..................................... 40 Table 11 Overall Exposure to PL2200 by Dose ...........................................................
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