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PHARMACOLOGY REVIEW(S) Comments on N22288 Bepotastine Besilate Bepreve from A

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PHARMACOLOGY REVIEW(S) Comments on N22288 Bepotastine Besilate Bepreve from A CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-006 PHARMACOLOGY REVIEW(S) Comments on N22288 bepotastine besilate Bepreve From A. Jacobs 8/27/09 I concur that there are no outstanding pharm/tox issues and the pregnancy category should be C, since the adverse effects might be applicable to the use of the API for other indications for which systemic exposure might be considerably higher. My previous comments to the reviewer on the pharm/tox portion of labeling and on the pharm/tox review have been addressed. Submission Linked Applications Type/Number Sponsor Name Drug Name / Subject -------------------- -------------------- -------------------- ------------------------------------------ NDA 22288 ORIG 1 ISTA BEPOTASTINE BESILATE PHARMACEUTICA OPHTHALMIC SOLUTION LS --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- ABIGAIL ABBY C C JACOBS 08/27/2009 DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PHARMACOLOGY/TOXICOLOGY REVIEW AND EVALUATION NDA NUMBER: 22-288 SERIAL NUMBER: 0000, 0008, 0014, 0016 and 0017 DATE RECEIVED BY CENTER: 11/14/08 PRODUCT: BepreveTM INTENDED CLINICAL POPULATION: allergic conjunctivitis in patients aged 3 years and older SPONSOR: ISTA, Pharmaceuticals®, Inc., Irvine, CA DOCUMENTS REVIEWED: Module 4 Documents submitted 11/14/2008 and 3/11/2009, 5/29/2009, 6/5/2009 and 6/12/2009 REVIEW DIVISION: Division of Anti-Infective and Ophthalmology Products (HFD-520) PHARM/TOX REVIEWER: Theresa Allio, Ph.D. PHARM/TOX SUPERVISOR: Wendelyn Schmidt, Ph.D. DIVISION DIRECTOR: Wiley Chambers, M.D. PROJECT MANAGER: Rafael Rodriguez Date of review submission to Division File System (DFS): July 21, 2009 TABLE OF CONTENTS EXECUTIVE SUMMARY .............................................................................................. 3 2.6 PHARMACOLOGY/TOXICOLOGY REVIEW................................................... 6 2.6.1 INTRODUCTION AND DRUG HISTORY................................................................... 6 2.6.2 PHARMACOLOGY....................................................................................................... 11 2.6.2.1 Brief summary ...................................................................................................................... 11 2.6.2.2 Primary pharmacodynamics ................................................................................................. 11 2.6.2.3 Secondary pharmacodynamics ............................................................................................. 26 2.6.2.4 Safety pharmacology ............................................................................................................ 26 2.6.2.5 Pharmacodynamic drug interactions..................................................................................... 30 No studies were conducted to evaluate drug interactions. ....................................................................... 30 2.6.3 PHARMACOLOGY TABULATED SUMMARY....................................................... 30 2.6.4 PHARMACOKINETICS/TOXICOKINETICS .......................................................... 32 2.6.4.1 Brief summary ...................................................................................................................... 32 2.6.4.2 Methods of Analysis.............................................................................................................33 2.6.4.3 Absorption ............................................................................................................................ 34 2.6.4.4 Distribution........................................................................................................................... 37 2.6.4.5 Metabolism........................................................................................................................... 38 2.6.4.6 Excretion............................................................................................................................. 41 2.6.4.7 Pharmacokinetic drug interactions...................................................................................... 42 2.6.4.8 Other Pharmacokinetic Studies............................................................................................. 42 2.6.4.9 Discussion and Conclusions ................................................................................................. 42 2.6.4.10 Tables and figures to include comparative TK summary ..................................................... 43 2.6.5 PHARMACOKINETICS TABULATED SUMMARY............................................... 43 2.6.6 TOXICOLOGY............................................................................................................... 43 2.6.6.1 Overall toxicology summary ................................................................................................ 43 2.6.6.2 Single-dose toxicity .............................................................................................................. 47 2.6.6.3 Repeat-dose toxicity ............................................................................................................. 51 2.6.6.4 Genetic toxicology................................................................................................................ 74 2.6.6.5 Carcinogenicity..................................................................................................................... 78 2.6.6.6 Reproductive and developmental toxicology...................................................................... 104 2.6.6.7 Local tolerance ................................................................................................................... 116 2.6.6.8 Special toxicology studies .................................................................................................. 116 2.6.6.9 Discussion and Conclusions ............................................................................................... 121 2.6.6.10 Tables and Figures.............................................................................................................. 127 2.6.7 TOXICOLOGY TABULATED SUMMARY ............................................................ 127 OVERALL CONCLUSIONS AND RECOMMENDATIONS............................................. 127 APPENDIX/ATTACHMENTS ............................................................................................... 130 2 Reviewer: Theresa Allio, Ph.D. NDA No. 22-288 EXECUTIVE SUMMARY I. Recommendations A. Recommendation on approvability There are no objections to the approval of this NDA from a pharm/tox perspective B. Recommendation for nonclinical studies No additional nonclinical studies are recommended. C. Recommendations on labeling 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogensis, Mutagenesis and Impairment of Fertility Long term dietary studies in mice and rats were conducted to evaluate the carcinogenic potential of bepotastine besilate. Bepotastine besilate did not significantly induce neoplasms in mice receiving a nominal dose of up to 200 mg/kg/day for 21 months or rats receiving a nominal dose of up to 97 mg/kg/day for 24 months. These dose levels represent systemic exposures approximating 350 and 200 times that achieved with human topical ocular use. The no observable adverse effect level for bepotastine besilate based on nominal dose levels in these carcinogenicity tests were 18.7 to 19.9 mg/kg/day in mice and 9.58 to 9.8 mg/kg/day in rats (representing exposure margins of 60 and 17.7 times the systemic exposure anticipated for human topical ocular use). There was no evidence of mutagenicity in the Ames test, in CHO cells (chromosome aberrations), in mouse hepatocytes (unscheduled DNA synthesis) or in the mouse micronucleus test. When oral bepotastine was administered to male and female rats at doses up to 1,000 mg/kg/day, there was a slight reduction in fertility index and surviving fetuses. Infertility was not seen in rats given 200 mg/kg/day oral bepotastine besilate (approximately 3330 times the maximum systemic concentration anticipated for topical ocular use in humans). 8.1 Pregnancy Pregnancy Category C: Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats at oral doses up to 200 mg/kg/day (representing a maximal systemic concentration approximately 3300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral doses up to 500 mg/kg/day (>13,000 times the dose in humans on a mg/kg basis). Evidence of infertility and conceptus loss was seen in rats given oral bepotastine besilate 1000 mg/kg/day; however, no evidence of infertility was observed in rats given 200 mg/kg/day (representing a maximal systemic concentration approximately 3330 times that anticipated for topical ocular use in humans). The concentration of radiolabeled bepotastine besilate was similar in fetal liver and maternal blood plasma following a single 3 mg/kg oral dose. The concentration in other fetal tissues was one-third
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