Uprima apomorphine HCl tablets sublingual Presentation to the Urology Subcommittee of the Advisory Committee for Rep .


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Speakers. James Freston, M.D., Ph.D. Educator of Medicine and Clinical Pharmacology University of Connecticut Health CenterBarbara Bopp, Ph.D. Administrator, Drug Metabolism and Pharmacology TAP Holdings Inc.Jeremy Heaton, M.D. Teacher, Dept. of Urology, Dept. of Pharmacology
Transcripts
Slide 1

Uprima ® (apomorphine HCl tablets) sublingual Presentation to the Urology Subcommittee of the Advisory Committee for Reproductive Health Drugs April 10, 2000 TAP HOLDINGS INC. E001451 Primary 1 6/9/2014

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Speakers Introduction James Freston, M.D., Ph.D. Teacher of Medicine and Clinical Pharmacology University of Connecticut Health Center Barbara Bopp, Ph.D. Chief, Drug Metabolism and Pharmacology TAP Holdings Inc. Jeremy Heaton, M.D. Teacher, Dept. of Urology, Dept. of Pharmacology & Toxicology Queens University Kingston, Ontario, Canada Timothy Fagan, M.D. Teacher of Medicine and Associate Professor of Pharmacology University of Arizona College of Medicine

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TAP Participants Introduction John Seely, Ph.D. VP, Research and Development Dean Sundberg Director, Regulatory Affairs Karl Agre, M.D., Ph.D. Senior Director, Medical Affairs Susan Buttler, M.S. Relate Director, Clinical Development Dennis Jennings, Ph.D. Executive of Scientific Data Analysis James Lancaster, Ph.D. Supervisor, Clinical Statistics

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TAP Participants (cont.) Introduction Anthony Edmonds, M.S. Senior Statistician Dustin Ruff, Ph.D. Analyst Renee Perdok, M.S. Analyst Farrel Fort, Ph.D., D.A.B.T. Administrator, Drug Safety

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Cully Carson, M.D. Boss - Division of Urology University of North Carolina Chapel Hill, NC Eugene Dula, M.D. Medicinal Director Western Urologic Associates Van Nuys, CA Ronald Lewis, M.D. Teacher of Urology Medical College of Georgia Augusta, GA Arnold Melman, M.D. Division of Urology Montefiore Hospital Bronx, NY TAP Consultants Introduction

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TAP Consultants Introduction Ray Rosen, Ph.D. Branch of Psychiatry Robert Wood Johnson Medical School Piscataway, NJ Addison Taylor, M.D. Educator of Medicine and Clinical Pharmacology Baylor College of Medicine Houston, TX Joel Morganroth, M.D. Chief Executive Officer Premier Research Philadelphia, PA Gary G. Koch, Ph.D. Factual Consultant Chapel Hill, NC

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TAP Presentations Introduction General Introduction … .… … .… … ..… … . Dr. Freston Apomorphine Pharmacokinetics and Metabolism … … Dr. Bopp ED Treatments… … Dr. Heaton Summary of Efficacy … .… … ....… … Dr. Heaton Summary of Safety .… .… … ...… … .. Dr. Freston, Dr. Fagan Benefit-Risk Assessment/Summary … … ..… … . Dr. Freston

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Topics Identified in FDA Briefing Document Introduction Comparison to other showcased ED drugs Representative ED quiet populace Pharmacokinetic variabilty Clinical importance of 2 mg Efficacy in diabetics Discontinuations in long haul thinks about Hemodynamics Nitrate collaboration Alcohol communication

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Erectile brokenness is the "powerlessness to achieve as well as keep up penile erection adequate for agreeable sexual execution" Erectile Dysfunction (ED) Introduction-ED Definition NIH Consensus Development Panel on Impotence JAMA 270: 83-90, 1993

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Erectile Dysfunction Introduction-ED Epidemiology and Demographics US National Health and Social Life Survey (NHSLS)- 1992 Probability test investigation of sexual conduct in men and ladies Demographically illustrative companion of 1,410 men, ages 18-59 Correlated ED to different judgments ED in 10% of men, ages 18-59 Laumann EO, Paik P, Rosen RC. JAMA 1999;281(6): 537-544

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Erectile Dysfunction Introduction-ED Epidemiology and Demographics Massachusetts Male Aging Study (MMAS) – 1987-1989 Cross-sectional, group based, irregular example review of 1,300 men, ages 40-70 Overall ED rate 52% Complete 10% Moderate 25% Minimal 17% Extrapolation to US: 30 million men with ED related with age, wellbeing status, passionate capacity Feldman et al. J. Urology 151: 54-61, 1994.

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Age Related Changes in Erectile Status Introduction-ED Massachusetts Male Aging Study (MMAS) % Age Extracted from Feldman et al. J. Urology 151: 54-61, 1994.

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Massachusetts Male Aging Study Introduction ED is Associated with: Age Diabetes Hypertension Heart malady Medications Depression Psychological elements Feldman et al. J. Urology 151: 54-61, 1994. Johannes et al. J. Urology 163: 460-463, 2000.

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ED Population Introduction Uprima ® Studies MMAS 1 Duration of ED (mean) 4.8 years Medical Condition (%) Hypertension 31% 33% Coronary Artery Disease (CAD) 16% 16% Hyperlipidemia 16% — Diabetes 16% 9% 1 Johannes et al. J. Urology 163: 460-463, 2000.

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Introduction to Apomorphine Introduction-Uprima USP tranquilize Used as a pharmacologic operator since 1869 Over 1,100 writing references Therapeutic measurements ran from 0.2 to 1500 mg Approximately 8,000 patients/subjects treated in clinical trials Approved in 12 nations for various signs, including Parkinson\'s Disease Daily organization Usual dosage 3 to 30 mg, subcutaneously Dopaminergic properties perceived in 1967 Central erectogenic impact perceived in the late 1970\'s Activates DA receptors in hypothalamic and limbic neural pathways

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Introduction to Uprima ® Introduction-Uprima Formulated to treat erectile brokenness Delivered sublingually (SL) Unique focal component of activity Rapid onset of activity Effective for erectile brokenness (ED) in a wide range of natural and non-natural etiologies and severities

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Introduction to Uprima ® Introduction-Uprima Safety No passings No myocardial areas of dead tissue (MI) identified with study medicate No cerebrovascular mishaps (CVAs) identified with study sedate No priapism Nausea was the most successive antagonistic occasion, syncope the most critical

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Proposed Indication Uprima ® is demonstrated for the treatment of erectile brokenness

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Doses Proposed measurements: 2, 3 and 4 mg Uprima ® will be accessible as a sublingual tablet

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Rationale for Uprima ® Treatment of ED Introduction-Uprima ED is connected with various maladies and conditions Drugs with various methods of activity are attractive as with different issue with complex pathophysiology, e.g., hypertension, dejection Current treatments are restricted: No medication is compelling in all patients Each medication has its own one of a kind unfavorable occasion profile The as of now endorsed specialists work by fringe instruments Treatment is firmly affected by couple and doctor decision New medications with various systems offer noteworthy potential advantages

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Rationale for Uprima ® Treatment of ED Introduction Uprima ® has a: Unique focal instrument of activity Novel conveyance framework Rapid onset Uprima ® has been studied in 27 clinical trials and has been appeared to be a sheltered and powerful treatment for ED in patients with and without known natural sicknesses

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Uprima ® Clinical Trials Introduction/Uprima (N = 3,035) Phase I Pharmacokinetics Metabolic destiny Elderly ( ³ 65 years) Renal/Hepatic Impaired Drug communications (Zofran ® , Compazine ® ) Special Phase I/II/III Antihypertensives and nitrates Diabetics Alcohol Prostatectomy Spinal rope damage Phase III Three controlled hybrid Dose-improvement One controlled parallel Five long haul, open-mark One first measurement regulated at home

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