Syndicated Thought Leader Insight

Thought Leader Insight & Analysis Report
Pharmacotherapies for Alcoholism Q1 2008
Therapeutic Class:

Focus Area:
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:
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:
Telephone: 513.271.1924 – Email: – Website: Pharmaceutical Competitive Intelligence – Market Research – Conference Coverage • 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 Telephone: 513.271.1924 – Email: – Website: Pharmaceutical Competitive Intelligence – Market Research – Conference Coverage 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: – Website: 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.

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