- Randomized, controlled study of Buvidal weekly and monthly subcutaneous depot injections vs daily sublingual buprenorphine
- The primary endpoint was met with statistically higher patient global satisfaction with the depot buprenorphine treatment
- Improved outcomes were also reported for secondary endpoints, including decreased treatment burden and higher quality of life
Lund, Sweden — 10 May 2021 — Camurus (NASDAQ STO: CAMX) announces today the publication in JAMA Network Open of results from a 24-week, randomized, controlled trial (DEBUT) comparing patient reported outcomes of opioid dependence treatment with subcutaneous weekly and monthly buprenorphine depot injections (Buvidal®) versus daily sublingual buprenorphine.
“The Depot Evaluation - Buprenorphine Utilization Trial (DEBUT) results published today showed that patients randomized to receive treatment for opioid dependence with weekly or monthly depot buprenorphine injections reported significantly higher and more sustained treatment satisfaction, less treatment burden and higher quality of life ratings than those treated with daily sublingual buprenorphine. The study’s focus on patient reported measures better informs patients and clinicians in selecting treatment options than clinical outcomes routinely used in previous studies of opioid dependence treatments” says Professor Nicholas Lintzeris, Conjoint Professor of Addiction Medicine, University of Sydney, Australia and principal investigator of the DEBUT study.
A total of 119 patients with opioid dependence were randomized and received treatment in the DEBUT study, conducted at six outpatient clinical sites in Australia. The primary outcome of the study was global treatment satisfaction, as measured by the 14-question Treatment Satisfaction Questionnaire for Medication (TSQM) at the end of the study at week 24. The study met its primary endpoint with a significantly higher TSQM global satisfaction score among participants who received depot injections compared to those who received sublingual buprenorphine (difference, 8.2; 95% CI, 1.7-14.6; P=.01).1 Improved outcomes were seen for several secondary outcomes, including a decreased treatment burden and higher quality of life. The safety profile was consistent with the known safety profile of buprenorphine, aside from transient, mild-to-moderate injection site reactions.
“This is to our knowledge the first randomized study performed to compare a range of different patient reported outcomes between a long-acting injection and daily dosing of buprenorphine in treatment of opioid dependence. The study highlights the use of different patient reported outcomes as alternate clinical study endpoints and demonstrates the value of Buvidal from a patient’s perspective,” says Dr. Peter Hjelmström, Chief Medical Officer at Camurus.
The full publication “Patient Reported Outcomes of Treatment of Opioid Dependence with Weekly and Monthly Subcutaneous Depot vs Daily Sublingual Buprenorphine: A Randomized Clinical Trial” is available online at JAMA Network Open today.
About DEBUT, Depot Evaluation - Buprenorphine Utilisation Trial
DEBUT is a prospective, randomized, open-label, active-controlled, multi-center trial comparing patient reported outcomes of weekly and monthly subcutaneous depot buprenorphine (Buvidal) with daily sublingual buprenorphine (standard of care) in adult outpatients with opioid dependence. 119 outpatients were randomized and received treatment 1:1 to 24 weeks of treatment with Buvidal or standard of care, e.g. Suboxone®, at six clinical sites in Australia. The primary endpoint of the study was the Treatment Satisfaction Questionnaire for Medication (TSQM) global satisfaction score. Secondary outcomes included PROs to assess treatment effectiveness, convenience, burden of treatment, quality of life, diversion and non-medical use of medication, health economic outcomes, as well as treatment retention, craving and withdrawal, illicit opioid use and safety and tolerability.
About Opioid Dependence
Opioid dependence is a serious, chronic, relapsing disease that can impact on 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, incarceration, transmission of infectious diseases, unintentional overdose and death. Opioids, including prescription pain relievers, heroin, and synthetic opioids such as fentanyl, are on the top the list of drugs that cause the greatest burden of disease and drug-related deaths worldwide.2
Buvidal is a medicine used to treat dependence on opioid (narcotic) drugs such as heroin or morphine. It is provided as weekly and monthly subcutaneous depot buprenorphine injections available in four weekly strengths (8mg, 16mg, 24mg and 32mg) and three monthly strengths (64mg, 96mg and 128mg) to allow flexible dosing according to patient's individual needs, including initiation of treatment and switching from corresponding doses of daily sublingual buprenorphine.
In the EU, Buvidal is indicated for treatment of opioid dependence within a framework of medical, social and psychological treatment, for use in adults and adolescents aged 16 years or over. For further information, see the EU Summary of Product Characteristics for Buvidal and the Australian Product information for Buvidal Weekly and Buvidal Monthly.
An additional 160mg monthly strength of Buvidal received a positive opinion by the European Medical Agency’s Committee for Medical Products for Human Use and recommended approval in the EU and was recently approved in Australia.
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
1. Lintzeris, N., et al. Patient-Reported Outcomes of Treatment of Opioid Dependence With Weekly and Monthly Subcutaneous Depot vs Daily Sublingual Buprenorphine. A Randomized Clinical Trial. JAMA Network Open. 2021;4(5):e219041. Doi:10.1001/jamanetworkopen.2021.9041
2. World Drug Report 2020 (United Nations publication, Sales No. E.20.XI.6) https://wdr.unodc.org/wdr2020/index.html
For more information
Fredrik Tiberg, CEO & Head of R&D
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