LUND, Sweden, Nov. 26, 2019 /PRNewswire/ -- Camurus announced
today topline results from the 24-week, randomized, controlled,
open-label, DEBUT study of weekly and monthly
Buvidal® (prolonged-release buprenorphine)
versus standard of care with daily sublingual buprenorphine (e.g.
Suboxone® Film) in 120 randomized outpatients at six
clinical sites in Australia.
The study, performed in real-world treatment setting with
validated patient reported outcomes, met the primary endpoint,
demonstrating superiority for the Treatment Satisfaction
Questionnaire for Medication1 (TSQM) global satisfaction
score for Buvidal® versus standard of care
at week 24, p=0.0143, as well as significantly higher TSQM
effectiveness and convenience domain scores, p<0.0001. In
addition, patients treated with Buvidal reported statistically
significant improvements in quality of life, reduced burden of
treatment, and other secondary outcomes versus daily standard of
care. Retention in treatment with Buvidal®
was high; with an 88% retention rate at week 24. Safety and
tolerability in DEBUT were consistent with the well-known safety
profiles of buprenorphine and Buvidal®.
"This is the first clinical study evaluating patient reported
outcomes and experiences of treatment with an extended release
buprenorphine depot head-to-head against standard of care with
daily sublingual medications. The topline results are very
encouraging and show significant improvements of multiple validated
patient reported measures, including treatment satisfaction,
quality of life, burden of treatment, and diversion and non-medical
use of medications" said Dr. Nicholas
Lintzeris, Professor of Addiction Medicine, University of Sydney, Australia and DEBUT
Coordinating Investigator.
"The positive DEBUT results add to our robust body of evidence
and provide significant insights on the benefits of weekly and
monthly Buvidal® compared to daily standard of care in
improving lives of patients with opioid dependence. Head-to-head
trials in real-world settings, such as DEBUT, are extremely
important to help clinicians better understand clinical and patient
reported outcomes, thereby supporting informed treatment
decisions," says Dr. Fredrik Tiberg,
President & CEO, Head of R&D at Camurus."
Detailed results from the DEBUT study will be presented in
forthcoming scientific publications.
About DEBUT, Depot Evaluation - Buprenorphine Utilisation
Trial
DEBUT is a prospective, randomized, open-label,
active-controlled, multi-center trial comparing patient reported
outcomes (PROs) of Buvidal® with buprenorphine
standard of care in adult outpatients with opioid dependence. 120
outpatients were randomized 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 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.2 According to the World Drug Report,
approximately 53 million individuals globally used opioids in 2017
and among those around 29 million used opiates such as heroin and
opium. Opioids top the list of drugs that cause the greatest burden
of disease and drug-related deaths worldwide.2
About Buvidal® (Brixadi™ / CAM2038)
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 mg, 16 mg,
24 mg and 32 mg) and three monthly strengths (64 mg,
96 mg and 128 mg), enabling treatment to be tailored to
the patient's individual needs. 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).3 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).3 The safety profile of
Buvidal® was comparable to daily sublingual
buprenorphine, except for mild to moderate injection site reactions
in a minority of patients. This was confirmed in a 48-week,
open-label study of Buvidal®, which also demonstrated
high treatment retention and patient satisfaction with
Buvidal®.4
Buvidal is the first long-acting buprenorphine approved for
the treatment of opioid dependence in Europe and Australia. Brixadi™ (the US tradename for
Buvidal®) is tentatively approved by the FDA.
About Camurus
Camurus is a Swedish, science-led biopharmaceutical company
committed to developing and commercializing innovative, long-acting
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
- Atkinson MJ, Sinha A, Hass SL, et al. Validation of a
general measure of treatment satisfaction, the Treatment
Satisfaction Questionnaire for Medication (TSQM), using a national
panel study of chronic disease. Health Qual Life Outcomes.
2004;2:12.
- World Drug Report 2019 (United Nations publication, Sales
No. E.19.XI.8). https://www.unodc.org/wdr2019/en/topics.html
Accessed November 2019 .
- 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
Intern Med. 2018; 178(6):764-773.
- Frost M, Bailey GL, Lintzeris N, et al.
Long-term safety of a weekly and monthly subcutaneous
buprenorphine depot (CAM2038) in the treatment of adult
out-patients with opioid use disorder. Addiction.
2019; 114(8):1416-1426
For more information
Fredrik Tiberg PhD
President & CEO, Head R&D
Tel. +46(0)46-286-46-92
fredrik.tiberg@camurus.com
Fredrik Joabsson PhD
Chief Business Development Officer
Tel. +46(0)70-776-17-37
ir@camurus.com
This is information that Camurus AB is obliged to make public
pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the managing
director, at 01:00 am CET on
26 November 2019.
This information was brought to you by Cision
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