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209575Orig1s000 CLINICAL REVIEW(S) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209575Orig1s000 CLINICAL REVIEW(S) CLINICAL REVIEW Application Type 505(b)(2) Application Number(s) 209575 Priority or Standard Standard Submit Date(s) 21 Sept 2017 Received Date(s) 21 Sept 2017 PDUFA Goal Date 21 July 2018 Division/Office DAAAP/OND Reviewer Name(s) Renee Petit-Scott, M.D. Review Completion Date 18 July 2018 Established/Proper Name 4% Cocaine HCl Topical Solution 10% Cocaine HCl Topical Solution (Proposed) Trade Name Numbrino Applicant Cody Laboratories, Incorporated Dosage Form(s) Topical solution Applicant Proposed Dosing One or two cotton or rayon applicator pledgets that are ½” x 3” Regimen(s) containing anesthetic solution should be applied topically per nostril, with a maximum of 2 pledgets used per nostril; maximum 4 pledgets per procedure Applicant Proposed For the introduction of local (topical) anesthesia Indication(s)/Population(s) for diagnostic procedures and surgeries on or through the accessible mucous membranes of the nasal cavities Recommendation on Complete Response Action for Numbrino™ 4% and 10% topical Regulatory Action solutions Recommended For the introduction of local (topical) anesthesia of the mucous Indication(s)/Population(s) membranes for diagnostic procedures and surgeries on or (if applicable) through the nasal cavities Reference ID: 42938654563674 NDA 209575 Cocaine HCL 4% and 10% Topical Solutions Table of Contents Glossary ..........................................................................................................................................7 1. Executive Summary .................................................................................................................9 1.1. Product Introduction........................................................................................................9 1.2. Conclusions on the Substantial Evidence of Effectiveness.............................................10 1.3. Benefit-Risk Assessment ................................................................................................10 1.4. Patient Experience Data.................................................................................................21 2. Therapeutic Context..............................................................................................................21 2.1. Analysis of Condition......................................................................................................21 2.2. Analysis of Current Treatment Options .........................................................................22 3. Regulatory Background .........................................................................................................25 3.1. U.S. Regulatory Actions and Marketing History.............................................................25 3.2. Summary of Presubmission/Submission Regulatory Activity ........................................26 3.3. Foreign Regulatory Actions and Marketing History .......................................................34 4. Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety ................................................................................................................35 4.1. Office of Scientific Investigations (OSI) ..........................................................................35 4.2. Product Quality ..............................................................................................................36 4.3. Clinical Microbiology......................................................................................................36 4.4. Nonclinical Pharmacology/Toxicology ...........................................................................36 4.5. Clinical Pharmacology ....................................................................................................36 4.6. Devices and Companion Diagnostic Issues ....................................................................43 4.7. Consumer Study Reviews...............................................................................................43 5. Sources of Clinical Data and Review Strategy .......................................................................44 5.1. Table of Clinical Studies .................................................................................................44 5.2. Review Strategy .............................................................................................................47 6. Review of Relevant Individual Trials Used to Support Efficacy .............................................48 6.1. A Phase 3 Study, COCA4vs10-001 ..................................................................................48 6.1.1. Study Design ...........................................................................................................48 6.1.2. Study Results ..........................................................................................................54 Clinical Review Petit-Scott, M.D. 2 Reference ID: 42938654563674 NDA 209575 Cocaine HCL 4% and 10% Topical Solutions 6.2 A Phase 3 Study, COCA4vs10-002………………………………………………………………………………62 6.2.1 Study Design……………………………………………………………………………………………………….62 6.2.2 Study Results………………………………………………………………………………………………………69 7. Integrated Review of Effectiveness.......................................................................................78 7.1. Assessment of Efficacy Across Trials ..............................................................................78 7.1.1. Primary Endpoints ..................................................................................................78 7.1.2. Secondary and Other Endpoints .............................................................................79 7.1.3. Subpopulations.......................................................................................................79 7.1.4. Dose and Dose-Response .......................................................................................79 7.1.5. Onset, Duration, and Durability of Efficacy Effects.................................................80 7.2. Additional Efficacy Considerations.................................................................................80 7.2.1. Considerations on Benefit in the Postmarket Setting.............................................80 7.2.2. Other Relevant Benefits..........................................................................................80 7.3. Integrated Assessment of Effectiveness ........................................................................81 8. Review of Safety....................................................................................................................83 8.1. Safety Review Approach ................................................................................................83 8.2. Review of the Safety Database ......................................................................................84 8.2.1. Overall Exposure.....................................................................................................84 8.2.2. Relevant characteristics of the safety population: .................................................85 8.2.3. Adequacy of the safety database: ..........................................................................85 8.3. Adequacy of Applicant’s Clinical Safety Assessments....................................................85 8.3.1. Issues Regarding Data Integrity and Submission Quality........................................85 8.3.2. Categorization of Adverse Events...........................................................................85 8.4. Safety Results.................................................................................................................87 8.4.1. Deaths.....................................................................................................................87 8.4.2. Serious Adverse Events...........................................................................................87 8.4.3. Dropouts and/or Discontinuations Due to Adverse Effects....................................88 8.4.4. Significant Adverse Events......................................................................................89 8.4.5. Treatment Emergent Adverse Events and Adverse Reactions ...............................90 8.4.6. Laboratory Findings ................................................................................................94 8.4.7. Vital Signs................................................................................................................95 8.4.8. Electrocardiograms (ECGs) .....................................................................................97 Clinical Review Petit-Scott, M.D. 3 Reference ID: 42938654563674 NDA 209575 Cocaine HCL 4% and 10% Topical Solutions 8.4.9. QT ...........................................................................................................................98 8.5. Analysis of Submission-Specific Safety Issues ..............................................................100 8.6. Safety Analyses by Demographic Subgroups ...............................................................100 8.7. Specific Safety Studies/Clinical Trials ...........................................................................101 8.8. Additional Safety Explorations.....................................................................................101 8.8.1. Human Reproduction
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