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021879Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 021879Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type N Application Number(s) N 21879 Priority or Standard Priority Submit Date(s) 4/30/10 Received Date(s) 4/30/10 PDUFA Goal Date 10/30/10 Reviewer Name(s) Devanand Jillapalli, MD Review Completion Date 9/25/10 Established Name Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) (Proposed) Trade Name Zenvia Therapeutic Class Applicant Avanir Pharmaceuticals Formulation(s) Capsule (b) (4) Dosing Regimen DM 20 mg/Q 10 mg Indication(s) Treatment of pseudobulbar affect Intended Population(s) Adult subjects with pseudobulbar affect. * Starting dose of one capsule of Zenvia 20 (DM 20 mg/Q 10 mg) (b) (4) daily by mouth for 7 days, and thereafter for Q12 hours. Clinical Review Devanand Jillapalli, MD NDA 021879 Dextromethorphan/Quinidine (Zenvia) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT.................................................................................8 1.1 Recommendation on Regulatory Action.............................................................................................................8 1.2 Risk Benefit Assessment.....................................................................................................................................8 1.3 Recommendations for Post-market Risk Management Activities.....................................................................24 1.4 Recommendations for Post-market Studies/Clinical Trials ..............................................................................24 2 INTRODUCTION AND REGULATORY BACKGROUND .............................................................................24 2.1 Product Information..........................................................................................................................................24 2.2 Tables of Currently Available Treatments for Proposed Indications................................................................25 2.3 Availability of Proposed Active Ingredient in the United States ......................................................................25 2.4 Important Safety Issues with Consideration to Related Drugs..........................................................................26 2.5 Summary of Pre-submission Regulatory Activity Related to Submission........................................................27 2.6 Other Relevant Background Information..........................................................................................................27 3 ETHICS AND GOOD CLINICAL PRACTICES ...............................................................................................27 3.1 Submission Quality and Integrity .....................................................................................................................27 3.2 Compliance with Good Clinical Practices ........................................................................................................27 3.3 Financial Disclosures........................................................................................................................................29 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES ............30 4.1 Chemistry Manufacturing and Controls............................................................................................................30 4.2 Clinical Microbiology.......................................................................................................................................30 4.3 Preclinical Pharmacology/Toxicology..............................................................................................................30 4.4 Clinical Pharmacology......................................................................................................................................30 4.4.1 Mechanism of Action................................................................................................................................30 4.4.2 Pharmacodynamics ...................................................................................................................................30 4.4.3 Pharmacokinetics ......................................................................................................................................31 5 SOURCES OF CLINICAL DATA........................................................................................................................32 5.1 Tables of Studies/Clinical Trials.......................................................................................................................33 5.2 Review Strategy................................................................................................................................................35 5.3 Discussion of Individual Studies/Clinical Trials...............................................................................................36 6 REVIEW OF EFFICACY .....................................................................................................................................40 6.1 Indication ..........................................................................................................................................................40 6.1.1 Methods.....................................................................................................................................................40 6.1.2 Demographics and baseline characteristics...............................................................................................44 6.1.3 Subject Disposition ...................................................................................................................................47 6.1.4 Analysis of Primary Endpoint(s)...............................................................................................................48 6.1.5 Analysis of Secondary Endpoints(s) .........................................................................................................54 6.1.6 Other Endpoints ........................................................................................................................................55 6.1.7 Subpopulations..........................................................................................................................................57 6.1.8 Analysis of Clinical Information Relevant to Dosing Recommendations.................................................57 6.1.9 Discussion of Persistence of Efficacy and/or Tolerance Effects...............................................................58 6.1.10 Additional Efficacy Issues/Analyses.......................................................................................................58 7 REVIEW OF SAFETY ..........................................................................................................................................59 7.1 Methods ............................................................................................................................................................59 7.1.1 Studies/Clinical Trials Used to Evaluate Safety........................................................................................60 7.1.2 Categorization of Adverse Events.............................................................................................................60 7.1.3 Pooling of Data across Studies/Clinical Trials to Estimate and Compare Incidence ................................62 2 Clinical Review Devanand Jillapalli, MD NDA 021879 Dextromethorphan/Quinidine (Zenvia) 7.2 Adequacy of Safety Assessments .....................................................................................................................63 7.2.1 Overall Exposure at Appropriate Doses/Durations and Demographics of Target Populations.................63 7.2.2 Explorations for Dose Response ...............................................................................................................66 7.2.3 Special Animal and/or In Vitro Testing ....................................................................................................66 7.2.4 Routine Clinical Testing ...........................................................................................................................66 7.2.5 Metabolic, Clearance, and Interaction Workup.........................................................................................67 7.2.6 Evaluation for Potential Adverse Events for Similar Drugs in Drug Class...............................................67 7.3 Major Safety Results.........................................................................................................................................67 7.3.1 Deaths .......................................................................................................................................................67 7.3.2 Serious Adverse Events.............................................................................................................................73 7.3.3 Dropouts and/or Discontinuations.............................................................................................................80 7.3.4 Significant Adverse Events .......................................................................................................................86 7.3.5 Submission Specific Primary Safety Concerns .........................................................................................88
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