DecisionBase

April 2013

Alcohol Addiction

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?

Scope:

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 period).

- 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 Modeling:

Current Therapies

- 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 Cyanamide)

Emerging Therapies

- Nalmefene (BioTie Therapies/Lundbeck’s Selincro)

- Samidorphan (Alkermes’ ALKS-33)

- AD-04 (ADial Pharmaceuticals)

- VLY-686 (Vanda Pharmaceuticals)


Search Reports

Mentioned in this report:

  • - Actavis
  • - ADial Pharmaceuticals
  • - AFOM Medical
  • - Alkermes
  • - Almirall
  • - BioTie Therapeutics
  • - Bristol-Myers Squibb
  • - Britannia Pharmaceuticals
  • - Faes Pharma
  • - Forest Laboratories
  • - Laboratorio BOHM
  • - Lacer
  • - Lundbeck
  • - Merck & Co.
  • - Merck Serono
  • - Mitsubishi Tanabe Pharma
  • - Nycomed
  • - Sanofi
  • - Sirton Pharmaceuticals
  • - Teva Pharmaceuticals
  • - Vanda Pharmaceuticals
  • - Zambon
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