- Buvidal® is the first long-acting medicine
approved in the EU for the treatment of opioid dependence in adults
and adolescents
LUND, Sweden, Nov.
22, 2018 /PRNewswire/ -- Camurus announced today that the
European Commission (EC) has approved weekly and monthly Buvidal®
(prolonged release buprenorphine) for the treatment of opioid
dependence in adults and adolescents from 16 years of age. This
marks the first approval of a long-acting treatment for opioid
dependence in the EU.
"Patients with opioid dependence in Europe 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. "Buvidal weekly and monthly subcutaneous
injection depots could become a game-changer in opioid dependence
treatment by improving adherence and reducing the burden, stigma
and risks of daily treatment."
Formulated with Camurus' proprietary FluidCrystal® injection
depot technology, Buvidal is a lipid-based solution which, once
injected, 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 patient's use of illicit opioids. [1-4]
"Today's approval of Buvidal provides an innovative and
much-needed new treatment option to the more than half a million
people with opioid dependence in Europe who are currently receiving daily
medication. We are committed to making Buvidal available for
patients as soon as possible, with the initial wave of country
launches scheduled for the first quarter of 2019," says Dr
Fredrik Tiberg, President and CEO of
Camurus. "This approval represents a major milestone for the
company. Our first long-acting medicine validates our FluidCrystal
technology which is the foundation of our extensive development
pipeline of new drug candidates," he adds.
The EC approval of Buvidal is based on safety and efficacy data
from a comprehensive global development program comprising seven
clinical studies, including a randomized, double-blind,
double-dummy, active controlled Phase 3 study in 428 patients with
opioid dependence. Results from this study demonstrated that
Buvidal provided improved treatment outcomes compared to daily
standard treatment with sublingual buprenorphine/naloxone. [2]
CAM2038 is also under review for marketing authorization in
Australia and the US. The US Food
and Drug Administration (FDA) has issued a PDUFA goal date of
26 December 2018 for CAM2038 to
Camurus' US partner Braeburn.
Notes to editors
The EC decision follows a positive opinion from the European
Medicines Agency's Committee for Medicinal Products for Human Use
on 21 September 2018, recommending
approval of Buvidal. This allows for marketing of Buvidal in all 28
member states of the EU, and the European Economic Area countries
Norway, Iceland and Liechtenstein.
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. The numbers are even higher in the US with
about 2.6 million people diagnosed with opioid use disorder and
close to 50,000 dying from opioid overdose in 2017. [7] This is now
the most common cause of death in people in the US under 50 years
of age. [8]
About Buvidal (CAM2038)
Buvidal
(buprenorphine prolonged release solution for subcutaneous
injection in prefilled syringe) has been developed for the
treatment of opioid dependence within a framework of medical,
social and psychological treatment. 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),
enabling treatment to be tailored to the patient's individual
needs. Buvidal is administered by healthcare professionals to
enhance treatment adherence, while potentially minimizing the risks
of diversion, misuse, overdose and accidental exposure to children
and teenagers.
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 switched 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. [2]
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.
About Camurus
Camurus is a Swedish
research-based pharmaceutical 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. Albayaty M, Linden M,
Olsson H, Johnsson M, Strandgarden K, Tiberg F. 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.
2. 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.
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. J Subst Abuse Treat. 2017; 78:22–29.
5. World Drug Report 2018 (United Nations publication, Sales No.
E.18.XI.9).
https://www.unodc.org/wdr2018/en/topics.html Accessed
November 2018.
6. European Monitoring Centre for Drugs and Drug Addiction.
European Drug Report
2018:http://www.emcdda.europa.eu/system/files/publications/8585/20181816_TDAT18001ENN_PDF.pdf
7. National Institute on Drug Abuse 2018.
www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
8. Centers for Disease Control and Prevention 2018.
www.cdc.gov/drugoverdose/data/
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 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 12.00 pm
CET on 22 November 2018.
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