Buvidal® (buprenorphine), the First Long-acting Treatment for Opioid Dependence in the EU, Is Now Available in the UK

- Buvidal^® is the first medicine with weekly and monthly dosing that is available to patients in the UK for the treatment of opioid dependence in adults and adolescents

LUND, Sweden, Feb. 4, 2019 /PRNewswire/ -- Camurus announced today that weekly and monthly Buvidal^® (buprenorphine prolonged release solution for subcutaneous injection) is now available in the UK. Buvidal^® is licensed to be prescribed within a framework of medical, social and psychological treatment to people with opioid dependence from 16 years of age.

"Patients with opioid dependence are in great need of new and more effective medications that can improve treatment outcomes and quality of life," says Professor Sir John Strang, Director of the National Addiction Centre, King's College, London. "New forms of buprenorphine, given as weekly and monthly subcutaneous depot injections, could become a game-changer in opioid dependence treatment by improving adherence and reducing the burden, stigma and risks of daily treatment."

Buvidal^® can be administered by healthcare professionals as a small volume injection under the skin and is designed to deliver sustained release of buprenorphine over weekly and monthly dosing intervals, thereby avoiding the burdens and risks of daily medication.

Buvidal^® has been studied in a comprehensive clinical study programme of seven Phase 1-3 clinical trials demonstrating that Buvidal^® delivers rapid, predictable and sustained release of buprenorphine over a week or month. In the pivotal Phase 3 study, Buvidal^® was shown to be non inferior to 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).^[1] The safety profile of Buvidal^® was generally consistent with the known safety profile of sublingual buprenorphine, with the exception of mild-to-moderate injection site reactions.

Formulated with Camurus' proprietary FluidCrystal^® injection depot technology, Buvidal^®, is a new, innovative lipid-based solution which distinguishes it from existing buprenorphine formulations. Once injected, it transforms into a gel-like depot. The depot slowly biodegrades over time, releasing the buprenorphine which blocks the drug-liking effect of opioids in the brain and reduces withdrawal, craving and the use of illicit opioids.^{[1],[2],[3],[4]}

"The launch of Buvidal^® in the UK is a significant milestone, both for people living with opioid dependence and for the doctors caring for them. We are pleased that, for the first time, physicians in the UK now have access to a long-acting opioid dependence therapy that can be individualised to specific patient needs and that has the potential to improve treatment outcomes compared to existing daily buprenorphine sublingual treatments," said Dr Fredrik Tiberg, President and CEO of Camurus.

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.^[5] According to the World Drug Report, approximately 34 million individuals globally use opioids for non-medical purposes and an estimated 127,000 people die each year from opioid overdoses.^[5] 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 630,000 receiving medical treatment.^[6] Each year, about 9,000 Europeans die from drug-related overdoses.

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.^[7] The disease often causes major medical, social and economic problems to both the individual and society.^[8] The Home Office estimates the economic and social impact of drug abuse in the UK is £15.4 billion, almost all of which is accounted for by opioid use.^[9] In the UK, over 330,000 drug users are injecting or using opioids regularly, with less than half receiving medical treatment.^[10] Of them, 40–50% of people discontinue treatment within six months, putting them at increased risk of resuming illicit opioid use.^{[11],[12],[13]} In 2018, deaths from drug misuse reached a record high in England and Wales, with almost 90% involving an opioid.^[10] 

About Buvidal^® (CAM2308)

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 (8, 16, 24 and 32 mg) and three-monthly strengths (64, 96, and 128 mg). Administration of Buvidal is restricted to general practitioners (GPs), nurses or other healthcare professionals.^[14]

Buvidal^® has been successfully evaluated in a comprehensive clinical program comprising five Phase 1 and 2 clinical studies and two Phase 3 studies, evaluating efficacy and long-term safety. The long-term study included both new-to-treatment patients as well as patients transferred from sublingual buprenorphine products.^[1] In the pivotal Phase 3 study, Buvidal^® was shown to be non inferior to 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).^[1] The safety profile of Buvidal^® was comparable to daily sublingual buprenorphine, except for mild to moderate injection site reactions.^[1] The most common side effects of Buvidal^® are headache, nausea, hyperhidrosis, insomnia and mild-to-moderate injection-site reactions.

Formulated with Camurus' FluidCrystal^® injection depot technology, Buvidal^® is presented ready for use in pre-filled 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.^[14]

For complete prescribing information, please visit: https://www.ema.europa.eu/documents/product-information/buvidal-epar-product-information_en.pdf

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/.

UK-BUV-1900016
Date of preparation: February 2019

References

[1] EPAR December 2018 EMEA/H/C/004651/0000 https://www.ema.europa.eu/documents/assessment-report/buvidal-epar-public-assessment-report_en.pdf. Last accessed January 2019.
[2] Albayaty M, Linden M, Olsson H, Johnsson M, et al. Pharmacokinetic evaluation of once-weekly and once-monthly buprenorphine subcutaneous injection depots (CAM2038) versus intravenous and sublingual buprenorphine in healthy volunteers under naltrexone blockade: an open-label Phase 1 study. Adv Ther 2017; 34(2):560–575.
[3] Walsh SL, Comer SD, Lofwall MR, et al. Effect of buprenorphine weekly depot (CAM2038) and hydromorphone blockade in individuals with opioid use disorder: a randomized clinical trial. JAMA psychiatry 2017; 74(9):894–902.
[4] Haasen C, Linden M, Tiberg F. Pharmacokinetics and pharmacodynamics of a buprenorphine subcutaneous depot formulation (CAM2038) for once-weekly dosing in patients with opioid use disorder. Journal of substance abuse treatment 2017; 78:22–29.
[5] World Drug Report 2018 (United Nations publication, Sales No. E.18.XI.9). Available at: https://www.unodc.org/wdr2018/en/topics.html Accessed November 2018. Last accessed January 2019.
[6] European Monitoring Centre for Drugs and Drug Addiction. United Kingdom Drug Report 2018. Available at: http://www.emcdda.europa.eu/system/files/publications/8894/united-kingdom-cdr-2018-with-numbers.pdf. Last accessed January 2019.
[7] McLellan AT, Lewis DC, O'brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. Jama. 2000 Oct 4;284(13):1689-95.
[8] 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 Jun 1;13(2):5-40.
[9] British Medicine Association Board of Science. Chapter 3 – The burden of illicit drug use. Available at: https://www.bma.org.uk/-/media/files/pdfs/news%20views%20analysis/in%20depth/drugs%20of%20dependence/drugsofdepend_chapter3.pdf. Last accessed January 2019.
[10] European Monitoring Centre for Drugs and Drug Addiction. United Kingdom Drug Report 2018. Available at: http://www.emcdda.europa.eu/system/files/publications/8894/united-kingdom-cdr-2018-with-numbers.pdf. Last accessed January 2019.
[11] Soyka M, Zingg C, Koller G, Kuefner H. Retention rate and substance use in methadone and buprenorphine maintenance therapy and predictors of outcome: results from a randomized study. The international journal of neuropsychopharmacology. 2008;11(5):641–653.
[12] Apelt SM, Scherbaum N, Golz J, et al. Safety, effectiveness and tolerance of buprenorphine-naloxone in the treatment of opioid dependence: results from a nationwide non-interventional study in routine care. Pharmacopsychiatry. 2013;46(3):94–107.
[13] Pinto H, Maskrey V, Swift L, Rumball D, et al. The SUMMIT trial: a field comparison of buprenorphine versus methadone maintenance treatment. J Subst Abuse Treat. 2010;39(4):340–352.
[14] Camurus. Buvidal^® Summary of Product Characteristics (SmPC). Camurus AB, Sweden. November 2018. Available at: https://www.ema.europa.eu/documents/product-information/buvidal-epar-product-information_en.pdf. Last accessed January 2019.