Thought Leader Insight & Analysis Report Pharmacotherapies for Alcoholism Q1 2008 Therapeutic Class: Focus Area: Specialty/Location:
Psychiatry, General Practice/ N. America
Number of Interviews: Number of Pages: Publication Date: March Principal Authors:
Jeffrey D. Berk, Ph.D., MBA Tricia L. Hanlon Kim Grant
Product Code: Pricing: Order Info:
Report Summary: This report is derived from seven primary interviews conducted with North American specialists in the treatment of alcoholism. Six are psychiatrists and one is a general practitioner. All are highly active in research and alcoholism clinical trials. Based on the lackluster commercial performance of naltrexone and acamprosate, Pharma has erroneously underestimated the size of the alcoholism market. The lack of clear FDA guidance on trial design and resulting indications has stymied many pharmaceutical companies from entering this category. There is a stigma associated with alcoholism. Companies may have a few product champions but the general corporate attitude is that developing drugs for alcoholism carries the same kind of corporate image risks as developing contraceptives and other “morality drugs”. There is also a tremendous fear of product liability litigation. The general corporate perception is that drugs for alcoholism won’t be reimbursable, and many of the people who come in for treatment will be “down and out” and not able to afford medicine. An analogy would be to forecast the size of the antidepressant market before the availability of Prozac. We are however at an inflection point. While competitive intensity in the alcoholism field has been low by traditional measures it is clearly now emerging. We expect to see tremendous competitive growth after the first successful product launches into the primary care physician’s office. To bring clarity to the debate on the course and speed of developments in this field the Panel tries to address a number of the underlying medical, regulatory, social and commercial issues. These include:
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• Unmet needs from the patient, specialist, general practitioner, 3rd-party payer and societal perspective. • Habits & practices of specialists, GPs and non-medical treaters.
• Hurdles preventing increased diagnosis and treatment of alcoholism, particularly in the community setting, and
a commercialization model that Pharma can follow to overcome these.
• Changing paradigms in primary and secondary clinical trial endpoints and alcoholism trial designs. • New screening tools and behavioral diagnostic instruments. Drugs/classes mentioned in this report include ReVia (naltrexone); Vivitrol (extended release injectable naltrexone; Alkermes / Cephalon); Campral (acamprosate; Forest); Antabuse (disulfiram); gabapentin (generic); Topamax (topiramate; Ortho-McNeil); Prometa (flumazanil / gabapentin / hydroyzine; Hythiam); glutamatergic; non-NMDA; kainate; AMPA; CB-1; Acomplia (rimonabant; Sanofi-Aventis); SSRI; dopaminergic; Seroquel (quetiapine; AstraZeneca); NPY; NK; CRH. Table of Contents Executive Summary. 4
Epidemiology. 5 Unmet Needs. 5 Habits & Practices . 6 Trial Design Issues. 8 On-Market / Near Market Pharmacotherapy .11 Pipeline Approaches.13
Incidence / Prevalence.15 Benefits / Unmet Needs.16
Product Profile .16 Patients .18 Specialists .19 Community Physicians.21 3rd-Party Payers / Employers.23
Specialty Physician Setting.23 Community Physician (Internist, General Psychiatrist) Setting .24 Non-Physician Setting.31 3rd-Party Payers.34
Clinical Endpoints .35 Running Studies .45
Preclinical .46 Clinical Trial Design .46 Active Comparators.48 Pharmacoeconomic Endpoints .49
Competitive Intensity.50 Barriers to Entry.51
On-Market / Near Market Pharmacotherapy .52
ReVia (naltrexone) .52 Vivitrol (extended release injectable naltrexone; Alkermes / Cephalon).56 Campral (acamprosate; Forest).59
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Antabuse (disulfiram) .60 Gabapentin (generic) .61 Topamax (topiramate; Ortho-McNeil).62 Prometa (flumazanil / gabapentin / hydroyzine; Hythiam) .64
Acomplia (rimonabant; Sanofi-Aventis).67 Other CB1 Antagonists.67
mecamylamine .68 Chantix (varenicline; Pfizer).68
Seroquel (quetiapine; AstraZeneca) .69 D1-Antagonists .70
Interview CNS01999 .73 Interview CNS02000 .86 Interview CNS02001 .94 Interview CNS02002 .102 Interview CNS02003 .112 Interview CNS02004 .121 Interview CNS02005 .130
Telephone: 513.271.1924 – Email: info@medpredict.com – Website: www.medpredict.com
Pharmaceutical Competitive Intelligence – Market Research – Conference Coverage
Nagoya University Graduate School of Medicine Education: Bachelor of Engineering, Dept. of Transportation Engineering, Tokyo Univ. of Sci., Master of Engineering, Dept. of Civil Engineering, Tokyo Univ. of Sci., 1993 Degree: Doctor of Engineering, Tokyo Univ. of Sci., 1999, Title of the Thesis: Design and analysis of randomized clinical trials with recurrent events. Employment: 1993.4-1995.
Risk Assessment Tool for the use of MRSA suppression therapy in Primary Care. Staphylococcus aureus is a common coloniser of human skin and mucosa, but can cause disease, particularly if there is an opportunity for the bacteria to enter the body. Meticillin-resistant S. aureus (MRSA) are a type of S. aureus resistant to antibiotics such as Flucloxacillin that are normally used to
Alcoholism