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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205223Orig1s000 MEDICAL REVIEW(S) Clinical Investigator Financial Disclosure Review Template Application Number: 205223 Submission Date(s): May 24, 2013 Applicant: Valeant Pharmaceuticals North America LLC Product: Metronidazole Vaginal Gel 1.3% Reviewer: Hala Shamsuddin, M.D. Date of Review: February 24, 2014 Covered Clinical Study (Name and/or Number): Study GW05-0904 Study MP-1601-01 Was a list of clinical investigators provided: Yes X No (Request list from applicant) Total number of investigators identified: 52 (fifty-two) Number of investigators who are sponsor employees (including both full-time and part-time employees): None Number of investigators with disclosable financial interests/arrangements (Form FDA 3455): 52 (fifty-two) If there are investigators with disclosable financial interests/arrangements, identify the number of investigators with interests/arrangements in each category (as defined in 21 CFR 54.2(a), (b), (c) and (f)): Compensation to the investigator for conducting the study where the value could be influenced by the outcome of the study: None Significant payments of other sorts: None Proprietary interest in the product tested held by investigator: None Significant equity interest held by investigator in sponsor of covered study: None Is an attachment provided with details Yes X No (Request details from of the disclosable financial applicant) interests/arrangements: Is a description of the steps taken to Yes X No (Request information minimize potential bias provided: from applicant) Number of investigators with certification of due diligence (Form FDA 3454, box 3) None Is an attachment provided with the NA No (Request explanation reason: Reference ID: 3464175 from applicant) Discuss whether the applicant has adequately disclosed financial interests/arrangements with clinical investigators as recommended in the guidance for industry Financial Disclosure by Clinical Investigators.1 Also discuss whether these interests/arrangements, investigators who are sponsor employees, or lack of disclosure despite due diligence raise questions about the integrity of the data: - If not, why not (e.g., study design (randomized, blinded, objective endpoints), clinical investigator provided minimal contribution to study data) - If yes, what steps were taken to address the financial interests/arrangements (e.g., statistical analysis excluding data from clinical investigators with such interests/arrangements) Briefly summarize whether the disclosed financial interests/arrangements, the inclusion of investigators who are sponsor employees, or lack of disclosure despite due diligence affect the approvability of the application. Reviewer’s Comments Certification was submitted that the sponsor had not entered into any financial arrangements with any of the clinical investigators whereby the value of compensation to the investigator could be affected by the outcome of the study as defined in 21CFR 54.2(a). Certification was provided that none of the listed investigator disclosed a proprietary interest in the product or significant equity in the sponsor as defined in 21 CFR 54.2(b) and (c), and that no listed investigator received significant payments of other sorts 21CFR (f). The applicant for NDA 205223 has adequately disclosed financial interests/arrangements with the clinical investigators. 1 See [web address]. Reference ID: 3464175 --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- HALA H SHAMSUDDIN 03/04/2014 Reference ID: 3464175 NDA 205223 SN000 Metronidazole Vaginal Gel 1.3% for the Treatment of Bacterial Vaginosis Clinical Review NDA 205223 SN 000 Type of Review Standard Submit Date May 24, 2103 PDUFA Goal Date March 24, 2014 Division of Anti-Infective Products (DAIP) Division/Office Office of Anti-microbial Products (OAP) Reviewer Hala Shamsuddin MD Team Leader Thomas Smith MD Product Metronidazole Vaginal Gel 1.3% Proposed Trade Name Metronidazole Vaginal Gel 1.3% Sponsor Valeant Pharmaceuticals Indication Treatment of Bacterial Vaginosis in Non-Pregnant Women 1 Reference ID: 3436511 NDA 205223 SN000 Metronidazole Vaginal Gel 1.3% for the Treatment of Bacterial Vaginosis Contents Recommendation on Regulatory Action ............................................................................. 5 Risk Benefit Assessment..................................................................................................... 5 Recommendations for Post-Market Risk Evaluation and Mitigation Strategies ................ 5 Recommendations for Post-Market Requirements and Commitments ............................... 5 Executive Summary ............................................................................................................ 5 Introduction ..................................................................................................................... 5 Efficacy ........................................................................................................................... 6 Safety .............................................................................................................................. 8 Pregnancy ........................................................................................................................ 9 Introduction ......................................................................................................................... 9 Bacterial Vaginosis ......................................................................................................... 9 Currently Available Treatments for BV ........................................................................... 10 Regulatory Background .................................................................................................... 10 Ethics................................................................................................................................. 11 Issues Related to Other Review Disciplines ..................................................................... 11 CMC .............................................................................................................................. 11 Microbiology................................................................................................................. 11 Toxicology .................................................................................................................... 12 Clinical Pharmacology .................................................................................................. 12 Sources of Clinical Data ................................................................................................... 12 PK Study MP-1601-02 ...................................................................................................... 13 Phase 2 Dose Ranging Study - Study GW05-904 ............................................................ 13 Study Design ................................................................................................................. 13 Subject Disposition ....................................................................................................... 15 Analysis Populations ..................................................................................................... 15 Demographics and Disease Characteristics .................................................................. 16 Primary Efficacy Endpoint ........................................................................................... 16 Secondary Efficacy Endpoints ...................................................................................... 17 Safety Evaluation .......................................................................................................... 18 Extent of Exposure .................................................................................................... 18 Concomitant Medications ......................................................................................... 18 Adverse Events ......................................................................................................... 18 2 Reference ID: 3436511 NDA 205223 SN000 Metronidazole Vaginal Gel 1.3% for the Treatment of Bacterial Vaginosis SAE ........................................................................................................................... 20 Pregnancies ............................................................................................................... 20 Phase 3 Placebo-Controlled Study - MP-1601-01 ............................................................ 21 Study Design ................................................................................................................. 21 Protocol Amendments ................................................................................................... 22 Subject Disposition ....................................................................................................... 22 Protocol Deviations ....................................................................................................... 23 Analysis Populations ....................................................................................................
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