Scottish Medicines Consortium accepts weekly and monthly Buvidal for treatment of opioid dependence

  • Buvidal® is the first weekly and monthly treatment for opioid dependence in adults and adolescents aged 16 years or over available to patients in Scotland
  • Opioid dependence is a significant problem in Scotland with an estimated 57,300 problem drug users and about 30,000 patients currently in treatment1,2
  • Patients with opioid dependence are at significant risk of overdose and Scotland has the highest drug death rate in the EU3,4

Cambridge, United Kingdom — 12 August 2019 — Camurus welcomes the Scottish Medicines Consortium (SMC) decision to accept Buvidal® (buprenorphine prolonged-release solution for subcutaneous injection) for restricted use in NHS Scotland for the treatment of opioid dependence within a framework of medical, social and psychological treatment, in adults and adolescents aged 16 years or over.5

Buvidal® injections, administered weekly or monthly, were approved by the European Commission in November 2018 based on safety and efficacy data from a comprehensive global development program comprising seven clinical studies, including a randomised, double-blind, double-dummy, active controlled Phase 3 study.6,7 Results from this study demonstrated that Buvidal® provided improved treatment outcomes compared to daily standard treatment with sublingual buprenorphine/naloxone.6

“Today’s news is a significant step forward in a field with a wide range of patients with different situations and needs. A broadening of the treatment options is welcome as there is currently a limited range of effective treatments.  Buvidal can contribute to improving adherence and reducing the burdens, stigma and risks associated with current daily treatments. Experience in clinical practice is, so far, limited but this intervention has potential to improve our ability to manage people with opiate dependency problems and could have an impact on the regrettable mortality”, said Professor Roy Robertson, Professor of Addictions, University of Edinburgh.

Last year in Scotland there were a record 1,187 deaths from drug overdoses, representing a 27 percent increase on the previous year and the highest since records began in 1996.3 The majority of these deaths (86%) resulted from overdosing with opioids.3 Scotland’s drug-related death rate is almost 3 times higher than that of the UK as a whole.3

The potential for Buvidal® to contribute to the reduction of opioid overdoses is described in the Buvidal® European Public Assessment Report that stated that compared to current standard treatment, due to its administration by health care professionals, prolonged buprenorphine release with less fluctuations and more stable levels, and rapid and sustained blockade of the effects of exogenously administered opioids, Buvidal® is expected to protect patients from illicit opioid use and potentially result in fewer occurrences of opioid overdoses.7

Additionally, as Buvidal® is administered by a healthcare professional this effectively eliminates the risks of medication misuse and diversion by patients as well as accidental paediatric exposure.

“We are pleased with the positive acceptance by the SMC acknowledging the economic case for Buvidal, and look forward to partnering with the treatment community to give patients in need access to the first long-acting treatment option for opioid dependence”, said Dr Ayana Gibbs, Head of Medical Affairs Northern Europe at Camurus.

 

The full text of the SMC decision can be found at: https://www.scottishmedicines.org.uk/medicines-advice/buprenorphine-buvidal-full-smc2169/

 

END

 

About opioid dependence / opioid use disorder 
Opioid dependence is a serious, chronic, relapsing disease that can affect all aspects of a person's daily life. It is an escalating global health problem, contributing to significant adverse mental, physical, and social consequences, including unemployment, criminal activity, incarceration, transmission of infectious diseases, unintentional overdose and death.8 According to the World Drug Report, approximately 34 million individuals globally use opioids for non-medical purposes and an estimated 127,000 deaths in 2015 were directly related with opioid drug use disorders (mainly overdoses).8 Opioids top the list of drugs that cause the greatest burden of disease and drug-related deaths worldwide. In Europe, an estimated 1.3 million people engage in high-risk opioid use, with only about 654,000 receiving medical treatment.4 In 2016, about 9,000 Europeans died from drug-related overdoses.4

Opioid dependence often involves cycles of relapse and remission, with similar relapse rates to other chronic diseases, such as type 2 diabetes, hypertension and asthma.9 The disease often causes major medical, social and economic problems to both the individual and society.10

About Buvidal® 
Buvidal® (buprenorphine prolonged-release solution for subcutaneous injection in a prefilled syringe) is indicated for the treatment of opioid dependence within a framework of medical, social and psychological treatment.6 Treatment is intended for use in adults and adolescents aged 16 years or over.6 Buvidal® is designed for flexible dosing and is available in four weekly doses (8, 16, 24 and 32 mg) and three monthly doses (64, 96, and 128 mg). Administration of Buvidal® is restricted to healthcare professionals.11,12

For complete prescribing information, please visit: https://www.medicines.org.uk/emc/product/9705/smpc
https://www.medicines.org.uk/emc/product/9706/smpc

About Camurus

Camurus is a Swedish research-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 http://www.camurus.com/.

 

Medical contact

Ayana Gibbs

Camurus Ltd

+44 (0)1223919700

ayana.gibbs@camurus.com

 

Media contacts

Yasmin Sheikh

WA Communications

+44 (0)20 7227 565

yasminsheikh@wacomms.co.uk

 

 

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References

 

  1. NHS National Services Scotland. Prevalence of Problem Drug Use in Scotland 2015/16 Estimates. 5 March 2019. Available at:https://www.isdscotland.org/Health-Topics/Drugs-and-Alcohol-Misuse/Publications/2019-03-05/2019-03-05-Drug-Prevalence-2015-16-Report.pdf. Last
  2. NHS National Services Scotland. Estimating the Prevalence of Problem Drug Use in Scotland, 2015-16 Estimates. 05 March 2019. Available at: https://www.isdscotland.org/Health-Topics/Drugs-and-Alcohol-Misuse/Publications/. Last accessed August 2019.
  3. National Records of Scotland. Drug-related Deaths in Scotland in 2018. Available at: https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/vital-events/deaths/drug-related-deaths-in-scotland/2018. Last accessed August 2019.
  4. European Monitoring Centre for Drugs and Drug Addiction. European Drug Report 2019. Available at: http://www.emcdda.europa.eu/system/files/publications/11364/20191724_TDAT19001ENN_PDF.pdf. Last accessed August 2019.
  5. Scottish Medicines Consortium. Medicines Advice: buprenorphine (Buvidal). Available at: https://www.scottishmedicines.org.uk/medicines-advice/buprenorphine-buvidal-full-smc2169/. Last accessed August 2019.
  6. European Medicines Agency. Buvidal (buprenorphine). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/buvidal. Last accessed August 2019.
  7. European Medicines Agency. Buvidal: EPAR - Public assessment report, December 2018. Available at: https://www.ema.europa.eu/en/documents/assessment-report/buvidal-epar-public-assessment-report_en.pdf. Last accessed August 2019.
  8. World Drug Report 2018 (United Nations publication, Sales No. E.18.XI.9). Available at: https://www.unodc.org/wdr2018/en/topics.html. Last accessed August 2019.
  9. McLellan AT, Lewis DC, O'brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. Jama. 2000; 284(13):1689-95.
  10. Maremmani I, Pacini M, Pani PP. Basics on addiction: a training package for medical practitioners or psychiatrists who treat opioid dependence. Heroin Addiction and Related Clinical Problems. 2011; 13(2):5-40.
  11. Buvidal 8/16/24/32 mg prolonged-release solution for injection Summary of Product Characteristics (SmPC). 21 June 2019. Available at:https://www.medicines.org.uk/emc/product/9705/smpc. Last accessed August 2019.
  12. Buvidal 64/96/128 mg prolonged-release solution for injection Summary of Product Characteristics (SmPC). 21 June 2019. Available at:https://www.medicines.org.uk/emc/product/9706/smpc. Last accessed August 2019.

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