LUND, Sweden, June 4, 2019 /PRNewswire/ -- Camurus announces
that the leading drug dependence journal Addiction has today
published full results from a 48-week, open-label, global Phase 3
study of weekly and monthly Buvidal® (prolonged-release
buprenorphine), the first and only long-acting injection medicine
to be approved for the treatment of opioid dependence in the EU and
Australia. The study confirmed the
safety and efficacy of Buvidal® in both new-to-treatment
patients and patients transferring from standard of care with daily
sublingual buprenorphine/naloxone.
"The Phase 3 results, published today in Addiction, show
that individualized treatment of opioid dependence with weekly and
monthly Buvidal® provides high levels of efficacy and is
well-tolerated by patients, whether they are transferred from other
forms of buprenorphine or are new entrants to treatment," says
Professor Nicholas Lintzeris,
Conjoint Professor of Addiction Medicine, University of Sydney, Australia and co-author of
the manuscript.
"We are pleased with the publication of the results of our Phase
3 long-term safety study, designed to mimic real-world clinical
practice, further extending the evidence base for
Buvidal® as an effective treatment of opioid dependence.
Additionally, the study shows a high degree of patient satisfaction
with Buvidal® compared with daily sublingual therapy,
confirming the response from patients and healthcare providers
obtained since the launch of Buvidal® in Europe earlier this year," says Dr
Fredrik Tiberg, President & CEO,
Camurus."
Buvidal®, formulated with Camurus'
FluidCrystal® injection depot technology, offers
flexible and individualized weekly and monthly dosing, according to
patient needs. A total of 227 patients received treatment with
Buvidal® in the long-term Phase 3 safety study, which
was conducted at 26 sites across the US, UK, Denmark, Sweden, Germany, Hungary and Australia.
In total, 167 patients (73.6%) completed the 48-week study, with
more than 5,000 injections of Buvidal® administered.
Buvidal® was well-tolerated and had a systemic safety
profile consistent with the known profile of buprenorphine. In a
patient satisfaction survey, 83.4% of participants who were
transferred from daily sublingual buprenorphine responded that
Buvidal® was "much better" (68.4%) or "slightly better"
(15.0%) than their previous treatment. Furthermore, weekly and
monthly Buvidal® was effective in reducing and
maintaining low opioid withdrawal and cravings scores. The degree
of abstinence at the end of the treatment period was high, with
63.0% (17/37) of new-to-treatment patients and 82.8% (111/190) of
patients transferred from daily sublingual buprenorphine having
negative urine tests (including negative self-reports for illicit
opioid use). Importantly, no opioid overdoses were reported for
patients treated with Buvidal®.
The full manuscript, "Long-term safety of a weekly and monthly
subcutaneous buprenorphine depot (CAM2038) in the treatment of
adult outpatients with opioid use disorder"
(https://onlinelibrary.wiley.com/doi/full/10.1111/add.14636) is
available online in Addiction today.
About Buvidal®
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 (8mg, 16mg, 24mg and 32mg) and three monthly
strengths (64mg, 96mg and 128mg), enabling treatment to be tailored
to the patient's individual needs.
Formulated with Camurus' FluidCrystal® injection
depot technology, Buvidal® is presented ready for use in
prefilled 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.
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). 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.[1]
Buvidal® is approved for the treatment of opioid dependence
in Europe and Australia.
Brixadi™ (the US tradename for
Buvidal®) is tentatively approved by the FDA for
patients who have initiated treatment with a single dose of a
transmucosal buprenorphine product or who are already being treated
with buprenorphine.
About Camurus
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.
References
- 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.
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 was submitted for publication at 9:00 am CET on 4 June
2019.
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