• Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Data Privacy
  • Sign Up
  • Send a Release
Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • News
  • Products
    • Overview
    • Content Distribution
    • Multimedia Services
    • Disclosure Services
    • Cision Communications Cloud®
  • Contact
    • General Enquiries
    • Media Enquiries
    • Partnerships
    • Worldwide Offices

 

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
      • Stock Offering
      • Stock Split
      • Venture Capital


      • View All Financial Services & Investing
      • General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • 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
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women


      • View All People & Culture
  • Overview
  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Worldwide Offices
  • 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

  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • News in Focus
    • Browse News Releases
    • Regulatory News
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Policy & Public Interest
    • Policy & Public Interest
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • People & Culture
    • People & Culture
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • Overview
  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Worldwide Offices
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR

Camurus Announces Publication of Phase 3 Study Results Showing Long-term Safety, Efficacy and High Rates of Patient Satisfaction With Buvidal®


News provided by

Camurus AB

04 Jun, 2019, 08:38 BST

Share this article


- Individualized treatment of opioid dependence with weekly and monthly Buvidal® was well-tolerated and effective, with a high (73.6%) patient retention across the 48-week study

- 83.4% of participants transferred from daily sublingual buprenorphine responded that Buvidal® was better than their previous treatment

LUND, Sweden, June 4, 2019 /PRNewswire/ -- Camurus announces that the leading drug dependence journal Addiction has today published full results from a 48-week, open-label, global Phase 3 study of weekly and monthly Buvidal® (prolonged-release buprenorphine), the first and only long-acting injection medicine to be approved for the treatment of opioid dependence in the EU and Australia. The study confirmed the safety and efficacy of Buvidal® in both new-to-treatment patients and patients transferring from standard of care with daily sublingual buprenorphine/naloxone.

"The Phase 3 results, published today in Addiction, show that individualized treatment of opioid dependence with weekly and monthly Buvidal® provides high levels of efficacy and is well-tolerated by patients, whether they are transferred from other forms of buprenorphine or are new entrants to treatment," says Professor Nicholas Lintzeris, Conjoint Professor of Addiction Medicine, University of Sydney, Australia and co-author of the manuscript.

"We are pleased with the publication of the results of our Phase 3 long-term safety study, designed to mimic real-world clinical practice, further extending the evidence base for Buvidal® as an effective treatment of opioid dependence. Additionally, the study shows a high degree of patient satisfaction with Buvidal® compared with daily sublingual therapy, confirming the response from patients and healthcare providers obtained since the launch of Buvidal® in Europe earlier this year," says Dr Fredrik Tiberg, President & CEO, Camurus."

Buvidal®, formulated with Camurus' FluidCrystal® injection depot technology, offers flexible and individualized weekly and monthly dosing, according to patient needs. A total of 227 patients received treatment with Buvidal® in the long-term Phase 3 safety study, which was conducted at 26 sites across the US, UK, Denmark, Sweden, Germany, Hungary and Australia.

In total, 167 patients (73.6%) completed the 48-week study, with more than 5,000 injections of Buvidal® administered. Buvidal® was well-tolerated and had a systemic safety profile consistent with the known profile of buprenorphine. In a patient satisfaction survey, 83.4% of participants who were transferred from daily sublingual buprenorphine responded that Buvidal® was "much better" (68.4%) or "slightly better" (15.0%) than their previous treatment. Furthermore, weekly and monthly Buvidal® was effective in reducing and maintaining low opioid withdrawal and cravings scores. The degree of abstinence at the end of the treatment period was high, with 63.0% (17/37) of new-to-treatment patients and 82.8% (111/190) of patients transferred from daily sublingual buprenorphine having negative urine tests (including negative self-reports for illicit opioid use). Importantly, no opioid overdoses were reported for patients treated with Buvidal®.

The full manuscript, "Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult outpatients with opioid use disorder" (https://onlinelibrary.wiley.com/doi/full/10.1111/add.14636) is available online in Addiction today.

About Buvidal®

Buvidal® (buprenorphine prolonged-release solution for subcutaneous injection in prefilled syringe) is indicated for the treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over. Buvidal® is designed for flexible dosing and is available in four weekly strengths (8mg, 16mg, 24mg and 32mg) and three monthly strengths (64mg, 96mg and 128mg), enabling treatment to be tailored to the patient's individual needs.

Formulated with Camurus' FluidCrystal® injection depot technology, Buvidal® is presented ready for use in prefilled syringes for weekly or monthly administration as small dose volume subcutaneous injection through a thin, 23-gauge needle. Buvidal® has been developed for room temperature storage, avoiding the need for cold chain distribution and refrigerator storage. Therefore, no mixing steps or room temperature conditioning are required prior to administration. Administration of Buvidal® is restricted to healthcare professionals.

Buvidal® has been successfully evaluated in a comprehensive clinical program comprising five Phase 1 and 2 clinical studies and two Phase 3 efficacy and long-term safety studies including both new-to-treatment patients as well as patients transferred from sublingual buprenorphine products. In the pivotal Phase 3 study, Buvidal® was shown to be at least as effective as standard treatment with daily buprenorphine/naloxone for the primary endpoint of the mean percent urine tests negative for illicit opioids (p<0.001). Superior treatment effect was demonstrated for the key secondary endpoint of cumulative distribution function for the percent urine tests negative for illicit opioid use (p=0.008). The safety profile of Buvidal® was comparable to daily sublingual buprenorphine, except for mild to moderate injection site reactions.[1]

Buvidal® is approved for the treatment of opioid dependence in Europe and Australia.

Brixadi™ (the US tradename for Buvidal®) is tentatively approved by the FDA for patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

About Camurus

Camurus is a Swedish science-led biopharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus' clinical pipeline includes products for the treatment of cancer, endocrine diseases, pain and addiction, which are developed in-house and in collaboration with international pharmaceutical companies. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com.  

References

  1. Lofwall MR, Walsh SL, Nunes EV, et al. Weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: A randomized clinical trial. JAMA Inter Med. 2018; 178(6):764–773.

For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46-286-46-92
fredrik.tiberg@camurus.com

Fredrik Joabsson, VP Business Development
Tel. +46 (0)70-776-17-37
ir@camurus.com

This information was submitted for publication at 9:00 am CET on 4 June 2019.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/camurus-ab/r/camurus-announces-publication-of-phase-3-study-results-showing-long-term-safety--efficacy-and-high-r,c2833312

The following files are available for download:

https://mb.cision.com/Main/13456/2833312/1057286.pdf

Press release (pdf)

SOURCE Camurus AB

Modal title

Also from this source

Swissmedic approves Buvidal for the treatment of opioid dependence...

Explore

More news releases in similar topics

  • Health Care & Hospitals
  • Medical Pharmaceuticals
  • Pharmaceuticals
  • Biotechnology
  • Publishing & Information Services

    Contact PR Newswire

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

    • General Enquiries
    • Media Enquiries
    • Partnerships
    • Worldwide Offices

    Products

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

    About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers

    • Asia
    • Brazil
    • Canada
    • Czech
    • Denmark
    • Finland
    • France
    • Germany
    • India
    • Israel
    • Mexico
    • Middle East
    • Netherlands
    • Norway
    • Poland
    • Portugal
    • Russia
    • Slovakia
    • Spain
    • Sweden
    • United States

    My Services

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

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 © 2021 PR Newswire Europe Limited. All Rights Reserved. A Cision company.