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206276 Olopatadine Clinical 2 BPCA Clinical Review of NDA 206276 Application Type NDA Application Number(s) 206276 Priority or Standard Priority Submit Date(s) July 30, 2014 Received Date(s) July 30, 2014 PDUFA Goal Date January 30, 2015 Review Division Division of Transplant and Ophthalmology Products Reviewer Name Wiley A. Chambers, MD Review Completion Date September 15, 2014 Established Name Olopatadine Hydrochloride Ophthalmic Solution 0. 7% (Proposed) Trade Name Pazeo Therapeutic Class Relatively selective histamine H1 antagonist and an inhibitor of the release of histamine from the mast cells Applicant Alcon Research Ltd Dosing Regimen One drop in each affected eye once a day Indication(s) Treatment of ocular itching associated with allergic conjunctivitis. Template Version: March 6, 2009 Reference ID: 3624796 Clinical Review of NDA 206276 Wiley A. Chambers, MD Olopatadine hydrochloride ophthalmic solution, 0.7% Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT .................................................. 4 1.1 Recommendation on Regulatory Action .......................................................................... 4 1.2 Risk Benefit Assessment .................................................................................................. 4 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies................ 4 1.4 Recommendations for Postmarket Requirements and Commitments .............................. 4 2 INTRODUCTION AND REGULATORY BACKGROUND ................................................ 4 2.1 Product Information.......................................................................................................... 4 2.2 Tables of Currently Available Treatments for Proposed Indications ............................... 4 2.3 Availability of Proposed Active Ingredient in the United States ..................................... 4 2.4 Important Safety Issues With Consideration to Related Drugs -None. ............................ 5 2.5 Summary of Presubmission Regulatory Activity Related to Submission ........................ 5 3 ETHICS AND GOOD CLINICAL PRACTICES ................................................................... 5 3.1 Submission Quality and Integrity ..................................................................................... 5 3.2 Compliance with Good Clinical Practices........................................................................ 5 3.3 Financial Disclosures- See separate review of Financial Disclosure. ............................. 5 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES ......................................................................................................................... 5 4.1 Chemistry Manufacturing and Controls ........................................................................... 5 4.2 Clinical Microbiology....................................................................................................... 7 4.3 Preclinical Pharmacology/Toxicology ............................................................................. 8 4.4 Clinical Pharmacology ................................................................................................... 10 4.4.1 Mechanism of Action .............................................................................................. 10 4.4.2 Pharmacodynamics – Not directly measured in humans......................................... 11 4.4.3 Pharmacokinetics..................................................................................................... 11 5 SOURCES OF CLINICAL DATA ....................................................................................... 13 5.1 Tables of Studies/Clinical Trials .................................................................................... 13 5.2 Review Strategy.............................................................................................................. 14 5.3 Discussion of Individual Studies/Clinical Trials ............................................................ 14 6 REVIEW OF EFFICACY ..................................................................................................... 21 6.1 Indication - Ocular Itching ............................................................................................. 21 6.1.1 Methods ................................................................................................................... 21 6.1.2 Demographics – All trials........................................................................................ 21 6.1.3 Subject Disposition.................................................................................................. 24 6.1.4 Analysis of Primary Endpoint - Itching .................................................................. 26 7 REVIEW OF SAFETY.......................................................................................................... 30 7.1 Methods .......................................................................................................................... 30 7.1.1 Studies/Clinical Trials Used to Evaluate Safety...................................................... 30 2 Reference ID: 3624796 Clinical Review of NDA 206276 Wiley A. Chambers, MD Olopatadine hydrochloride ophthalmic solution, 0.7% 7.1.2 Categorization of Adverse Events........................................................................... 31 7.1.3 Pooling of Data Across Studies/Clinical Trials to Estimate and Compare Incidence - N/A ........................................................................................................................ 31 7.2 Adequacy of Safety Assessments ................................................................................... 31 7.2.1 Overall Exposure at Appropriate Doses/Durations and Demographics of Target Populations .............................................................................................................. 31 7.3 Major Safety Results ...................................................................................................... 32 7.3.1 Deaths -None .......................................................................................................... 32 7.3.2 Nonfatal Serious Adverse Events -None ................................................................ 32 7.3.3 Dropouts and/or Discontinuations –None related to study medication................... 32 7.3.4 Significant Adverse Events –None.......................................................................... 32 7.4 Supportive Safety Results............................................................................................... 32 7.4.1 Common Adverse Events –see Table in 7.1.2......................................................... 32 7.4.2 Laboratory Findings -No significant finding........................................................... 32 7.4.3 Vital Signs -No significant findings. ....................................................................... 32 7.4.4 Electrocardiograms (ECGs) -Not performed........................................................... 32 7.4.5 Special Safety Studies/Clinical Trials ..................................................................... 32 7.5 Other Safety Explorations - None................................................................................... 33 7.6 Additional Safety Evaluations ........................................................................................ 33 7.6.1 Human Carcinogenicity -No human studies have been conducted. ........................ 33 7.6.2 Human Reproduction and Pregnancy Data ............................................................. 34 7.6.3 Pediatrics and Assessment of Effects on Growth.................................................... 34 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound – None. .................... 35 8 POST-MARKETING EXPERIENCE ................................................................................... 35 9. LABELING............................................................................................................................... 36 3 Reference ID: 3624796 Clinical Review of NDA 206276 Wiley A. Chambers, MD Olopatadine hydrochloride ophthalmic solution, 0.7% 1 Recommendations/Risk Benefit Assessment 1.1 Recommendation on Regulatory Action NDA 206276, Olopatadine hydrochloride ophthalmic solution, 0.7% is recommended to be approved for the treatment of ocular itching with the labeling attached to this review. 1.2 Risk Benefit Assessment Olopatadine hydrochloride ophthalmic solution, 0.7% has demonstrated efficacy in the treatment of ocular itching with minimal safety risks. The benefits are considered to outweigh the risks. 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies Routine postmarketing surveillance is recommended. 1.4 Recommendations for Postmarket Requirements and Commitments There are no recommended postmarketing commitments or requirements. 2 Introduction and Regulatory Background 2.1 Product Information Olopatadine is a sterile, multi-dose ophthalmic solution containing olopatadine for topical administration to the eyes. The formulation includes povidone, polyethylene glycol 400, hydroxypropyl methylcellulose hydroxypropyl-gamma-cyclodextrin, boric acid, mannitol, and benzalkonium chloride as (b) (4) preservative. 2.2 Tables of Currently Available Treatments for Proposed Indications Lastacaft Alcaftadine Ocular itching Optivar Azelastine Hydrochloride Ocular itching Bepreve Bepotastine
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