Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Alcohol-related Disorders: Ethypharm Is Granted Marketing Authorisation for Its Drug Baclocur®

This image opens in the lightbox

News provided by

Ethypharm

26 Oct, 2018, 07:00 GMT

Share this article

Share toX

Share this article

Share toX

SAINT CLOUD, France, October 26, 2018 /PRNewswire/ --

World first     
The National Agency for the Safety of Medicines and Healthcare Products (ANSM) has just granted Ethypharm marketing authorisation for its drug Baclocur® in France, a range of baclofen tablets in doses of 10, 20 and 40 mg. For more than 15 years, the use of baclofen in alcohol-related disorders has been the subject of numerous scientific publications across the world (Europe, USA, Australia, Israel, etc.). France is the first country to grant marketing authorisation to a baclofen preparation aimed at reducing alcohol consumption. Baclocur® is intended for use by alcohol-dependent adult patients with high-risk alcohol consumption. It should be prescribed by a doctor, preferably an addiction specialist, after other drug therapies have failed and used within the context of psychosocial support focused on compliance and reducing consumption. The maximum authorised daily dose is 80 mg per day.

     (Logo: https://mma.prnewswire.com/media/708212/Ethypharm_Logo.jpg )

Available in 2019    

Baclocur® should be available in the second half of 2019, after obtaining approval from the authorities and the opinion of the Transparency Commission from the French National Authority for Health, followed by a reimbursement price from the Economic Committee for Health Products.

Then alcohol-dependent patients who would benefit from treatment with baclofen will be given Baclocur®, the only form of baclofen authorised for this indication.

From the time when Baclocur® is launched on the market, Ethypharm will guarantee that its real-life use will be monitored. Systems for pharmacovigilance (CRPV), addictovigilance (CEIP-A) and toxicovigilance (CAP-TV) can also better observe baclofen's use within the scope of a marketing authorisation and a well-defined indication and thanks to a more easily identifiable drug.

Evaluation of Baclocur® in alcohol-related disorders

The application for marketing authorisation submitted by Ethypharm was subject to a special evaluation procedure, during which various stakeholders were able to express their opinions; these included patient associations and representatives of all the expert societies in the field of addiction treatment (French Federation for the Study of Addiction, French Society for the Study of Alcohol, Addiction Federation and MG Addiction, amongst others). On completion of the multidisciplinary evaluation, the ANSM granted marketing authorisation to Ethypharm for its drug Baclocur®.

Burden of the disease in France 
Alcohol is the cause of almost 400,000 hospital admissions and 50,000 deaths every year, including 15,000 due to cancer. By providing Baclocur®, Ethypharm would like to help to reduce the burden caused by alcohol alongside other social measures, such as reinforcing the ban on the sale of alcohol to minors, increasing tax on alcohol, preventative actions and training in early identification and brief intervention.

Faced with the scourge of alcohol, the marketing authorisation granted to Baclocur® again demonstrates the urgent need for strong action by all stakeholders (health authorities, healthcare professionals, expert societies and patient associations) in order to care for the tens of thousands of patients with alcohol problems and to continue to support them with the various pharmacological and non-pharmacological treatment options available.

Ethypharm, a company committed to the development and provision of drugs to treat addictions   
Baclocur® is the third Ethypharm drug to obtain marketing authorisation in the field of addictions in a year in France. This marketing authorisation follows the authorisations for Orobupré®, a substitute opioid drug that will be available in the next few days and Prenoxad®, a naloxone intramuscular kit and antidote to opioid overdoses.

This marketing authorisation is the fruit of development work since 2011 and confirms Ethypharm's involvement in the field of addictions where medical needs and patients' needs are still not sufficiently covered.

About Ethypharm 
Ethypharm is a European-based specialty pharmaceutical company with global reach and a committed player in the treatment of pain and addiction.

Ethypharm also develops and markets complex generics and essential medicines that help reduce healthcare costs, particularly in the field of emergency care and oncology.

The Company employs 1400 people mainly in Europe, and its drugs are marketed in more than 80 countries.

Our ambition is to become the European leader for the treatment of pain and addiction, and to help patients around the world gain access to high quality, essential and affordable medicines.

Contact Presse - Greta Guzman / presse@ethypharm.com /+ 33(0)1-41-12-17-20 

Modal title

Also from this source

Ethypharm announces the appointment of Éric CHEVALIER as Group Human Resources Director

Ethypharm announces the appointment of Éric CHEVALIER as Group Human Resources Director

Denis DELVAL, President & CEO of the Ethypharm Group, announces the appointment of Éric CHEVALIER as Group Human Resources Director with effect from...

ACQUISITION OF ARGATROBAN BUSINESS IN EUROPE

ACQUISITION OF ARGATROBAN BUSINESS IN EUROPE

Ethypharm has entered into an agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) to acquire the selective antithrombin agent, Argatroban...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Publishing & Information Services

Publishing & Information Services

Mental Health

Mental Health

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.