Introduction:How Would a Harm Reduction Treatment Paradigm Be
Received by Physicians?
As a result of low diagnosis and drug-treatment rates, the
market for alcohol addiction therapies remains very small despite the
relatively high prevalence of the disease. Current therapies approved for
alcohol addiction, such as disulfiram (Teva
Pharmaceuticals/Actavis/Nycomed/Laboratorio BOHM’s Antabuse/Antabus, AFOM
Medical’s Etiltox, Sanofi’s Esperal, Mitsubishi Tanabe Pharma’s Nocbin),
naltrexone (Teva’s ReVia, various brands and generics), and acamprosate (Forest
Laboratories’ Campral, Merck Serono’s Campral/Aotal, Almirall’s Zulex), suffer
from limited efficacy—further dissuading physicians from treating the disorder
with pharmacotherapy. Historically, therapies for alcohol addiction have been
indicated for the support of abstinence; however, BioTie/Lundbeck’s nalmefene
(Selincro) recently received approval in the EU for reducing alcohol
consumption in alcohol-dependent patients, and marketers are hopeful that
physicians will accept harm reduction as a meaningful treatment goal.
Questions Answered in This Report:
Abstinence from alcohol and reduced risk of relapse are key
goals in the treatment of alcohol addiction. What are the key primary and
secondary clinical trial end points with which new therapies are evaluated? How
do U.S. and European psychiatrists weight specific efficacy end points and
other drug attributes in their prescribing decisions for alcohol addiction?
Acamprosate is the 2012 major-market sales leader for alcohol
addiction. What weaknesses exist in its profile that would allow emerging
therapies to gain traction in the market? Have emerging therapies demonstrated
strengths on the attributes that surveyed psychiatrists indicate are the most
important in their prescribing decisions? Which emerging therapies will offer
the clinical improvements over currently available therapies that surveyed
managed care organization pharmacy directors (MCO PDs) seek from new therapies?
Based on its clinical profile, acamprosate is the current
clinical gold standard in our Drug Comparator Model. What attributes do
thought leaders believe differentiate this therapy from competing current
therapies and emerging therapies? Will any therapies in development challenge
acamprosate as the future gold standard in 2016 or 2021?
Attributes included in conjoint analysis-based assessment
of target product profiles for alcohol addiction:
- Percentage of patients maintaining complete abstinence
(following lead-in abstinence).
- Cumulative abstinence duration (% days abstinent during study
- Percentage of patients with no heavy drinking days.
- Reduction in alcohol consumption.
- Rate of nausea.
- Delivery burden.
- Patient out-of-pocket cost (for 30-day prescription).
Attributes included in assessment of U.S. payers’
receptivity to new therapies for alcohol addiction:
- Improved maintained abstinence from alcohol.
- Greater reduction in alcohol consumption.
- Lower rate of minor side effects.
- Reduced delivery burden.
Physicians surveyed: 61 U.S.
and 30 European psychiatrists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and
- Acamprosate (Forest Laboratories’ Campral, Merck Serono’s
Campral/Aotal, Almirall’s Zulex)
- Naltrexone microspheres (Alkermes’ Vivitrol)
- Naltrexone (Teva’s ReVia, Bristol-Myers Squibb’s
Nemexin/Nalorex, Lacer’s Celupan, Merck & Co.’s Nalorex, Zambon’s Antaxone,
Britannia Pharmaceuticals’ Opizone, Sirton Pharmaceuticals’ Narcoral, generics)
- Disulfiram (Teva Pharmaceuticals/Actavis/Nycomed/Laboratorio
BOHM’s Antabuse/Antabus, AFOM Medical’s Etiltox, Sanofi’s Esperal, Mitsubishi
Tanabe Pharma’s Nocbin)
- Cyanamide (Faes Farma’s Colme, Mitsubishi Tanabe Pharma’s
- Nalmefene (BioTie Therapies/Lundbeck’s Selincro)
- Samidorphan (Alkermes’ ALKS-33)
- AD-04 (ADial Pharmaceuticals)
- VLY-686 (Vanda Pharmaceuticals)