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208352Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208352Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-disciplinary Review and Evaluation NDA 208352 Lactic acid, citric acid, and potassium bitartrate (PHEXXI) NDA/BLA Multi-Disciplinary Review and Evaluation Application Type Resubmission Application Number(s) NDA 208352 (INDs 64,623 and 109,300) Priority or Standard Standard Submit Date(s) November 25, 2019 Received Date(s) November 25, 2019 PDUFA Goal Date May 25, 2020 Division/Office Division of Urology, Obstetrics and Gynecology (DUOG) Review Completion Date May 21, 2020 Established/Proper Name Lactic acid, citric acid, and potassium bitartrate (Proposed) Trade Name PHEXXI Class Contraceptive vaginal gel Applicant Evofem, Inc. Dosage form Gel Applicant proposed Dosing 5 grams of applicator instilled gel in vagina before each episode Regimen of vaginal intercourse Applicant Proposed Prevention of pregnancy in women who choose to use on- Indication(s)/Population(s) demand methods for their contraceptive needs Recommendation on Approval Regulatory Action 1 Version date: October 12, 2018 Reference ID: 46127754614956 NDA/BLA Multi-disciplinary Review and Evaluation NDA 208352 Lactic acid, citric acid, and potassium bitartrate (PHEXXI) Table of Contents Table of Tables .................................................................................................................... 5 Table of Figures ................................................................................................................... 7 Reviewers of Multi-Disciplinary Review and Evaluation .................................................... 8 Glossary ............................................................................................................................. 12 Executive Summary ..................................................................................................... 13 Product Introduction ............................................................................................ 13 Conclusions on the Substantial Evidence of Effectiveness ................................... 13 Benefit-Risk Assessment ....................................................................................... 14 Patient Experience Data ........................................................................................ 17 Therapeutic Context ................................................................................................... 18 Analysis of Condition ............................................................................................ 18 Analysis of Current Treatment Options ................................................................ 18 Regulatory Background ............................................................................................... 20 U.S. Regulatory Actions and Marketing History ................................................... 20 Summary of Presubmission/Submission Regulatory Activity ............................... 20 Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety ............................................................................. 24 Office of Scientific Investigations (OSI) ................................................................. 24 Product Quality ..................................................................................................... 24 Clinical Microbiology ............................................................................................. 26 Devices and Companion Diagnostic Issues ........................................................... 26 Nonclinical Pharmacology/Toxicology ........................................................................ 27 Executive Summary ............................................................................................... 27 Referenced NDAs, BLAs, DMFs ............................................................................. 28 Pharmacology ....................................................................................................... 28 ADME/PK ............................................................................................................... 28 Toxicology ............................................................................................................. 29 General Toxicology ........................................................................................ 29 Genetic Toxicology ......................................................................................... 30 Carcinogenicity .............................................................................................. 30 Reproductive and Developmental Toxicology ............................................... 31 Other Toxicology Studies ............................................................................... 32 Clinical Pharmacology ................................................................................................. 35 Executive Summary ............................................................................................... 35 Summary of Clinical Pharmacology Assessment .................................................. 35 2 Version date: October 12, 2018 Reference ID: 46127754614956 NDA/BLA Multi-disciplinary Review and Evaluation NDA 208352 Lactic acid, citric acid, and potassium bitartrate (PHEXXI) Pharmacology and Clinical Pharmacokinetics ............................................... 35 General Dosing and Therapeutic Individualization ....................................... 35 Comprehensive Clinical Pharmacology Review .................................................... 35 General Pharmacology and Pharmacokinetic Characteristics ....................... 35 Clinical Pharmacology Questions................................................................... 36 Sources of Clinical Data and Review Strategy ............................................................. 37 Table of Clinical Studies ........................................................................................ 37 Review Strategy .................................................................................................... 39 Statistical and Clinical and Evaluation ........................................................................ 40 Review of Relevant Individual Trials Used to Support Efficacy ............................ 40 EVO-002 ......................................................................................................... 40 Study AMP002 ............................................................................................... 46 Study Results .................................................................................................. 51 Integrated Assessment of Effectiveness ........................................................ 57 Review of Safety.................................................................................................... 57 Safety Review Approach ................................................................................ 57 Review of the Safety Database ...................................................................... 58 Adequacy of Applicant’s Clinical Safety Assessments ................................... 59 Safety Results ................................................................................................. 61 Analysis of Submission-Specific Safety Issues ............................................... 75 Clinical Outcome Assessment Analyses Informing Safety/Tolerability ......... 75 Safety Analyses by Demographic Subgroups ................................................. 75 Specific Safety Studies/Clinical Trials ............................................................. 75 Additional Safety Explorations....................................................................... 76 Safety in the Postmarket Setting ................................................................... 77 Integrated Assessment of Safety ................................................................... 77 Statistical Issues .................................................................................................... 79 Conclusions and Recommendations ..................................................................... 80 Advisory Committee Meeting and Other External Consultations .............................. 80 Pediatrics ..................................................................................................................... 80 Labeling Recommendations ........................................................................................ 80 Prescription Drug Labeling .................................................................................... 80 Risk Evaluation and Mitigation Strategies .................................................................. 81 Postmarketing Requirements and Commitment ........................................................ 81 Deputy Division Director Comments .......................................................................... 81 Deputy Division Director (Clinical) Comments ........................................................... 81 3 Version date: October 12, 2018 Reference ID: 46127754614956 NDA/BLA Multi-disciplinary Review and Evaluation NDA 208352 Lactic acid, citric acid, and potassium bitartrate (PHEXXI) Appendices .................................................................................................................
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