LUND, Sweden, Sept. 21, 2018 /PRNewswire/ -- Camurus (NASDAQ
STO: CAMX) announced today that the European Medicines Agency's
Committee for Medicinal Products for Human Use, CHMP, has adopted a
positive opinion recommending approval of Buvidal® (buprenorphine)
prolonged-release solution for injection for treatment of opioid
dependence in adults and adolescents from 16 years of age. The
final marketing authorisation for Buvidal® is expected to be
granted by the European Commission late November 2018.
"The excellent news that the CHMP recommends approval of
Buvidal® means that European patients and physicians could soon
have access to a new and effective treatment for opioid
dependence," said Fredrik Tiberg,
President and CEO of Camurus. "On Commission approval, Buvidal®
would become the first long-acting medicine available for treatment
of opioid dependence in Europe."
The CHMP positive opinion for Buvidal® is based on a
comprehensive clinical program with 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. [1]
CAM2038 is currently under regulatory review for approval in the
US and Australia. Camurus' partner
Braeburn is the sponsor for the regulatory procedure in the US.
About opioid dependence/opioid use disorder
Opioid dependence and opioid-related overdose deaths are
escalating global health problems [2, 3], contributing to
significant mental, physical, and social adverse consequences that
include transmission of infectious diseases, unintentional
overdose, criminal activity, and incarceration. [4, 5, 6] According
to the World Drug Report, approximately 33 million individuals
globally use opioids for nonmedical purposes. [7] Opioids top the
list of drugs that cause the greatest burden of disease and
drug-related deaths worldwide. An estimated 1.3 million people in
Europe engage in high-risk opioid
use, with only about 630,000 receiving medical treatment. [8] Each
year, about 9,000 Europeans die from drug-related overdoses. [8] In
the US, 2.6 million people are diagnosed with opioid dependence. In
2017, almost 50,000 Americans died from opioid- overdoses and drug
overdoses are now the most common cause of death in people under 50
years of age. [3, 7, 9]
About CAM2038 (Buvidal®)
CAM2038 weekly and monthly buprenorphine injection depots
have been developed for the treatment of opioid dependence within a
framework of medical, social and psychological treatment. CAM2038
is designed for flexible weekly and monthly dosing, allowing
tailored treatment to the patient's individual needs. CAM2038 will
be administered by healthcare professionals, which is expected to
increase treatment adherence, while potentially minimizing the
risks of diversion, misuse, overdoses and accidental exposure to
children and teenagers. CAM2038 has been successfully evaluated in
a comprehensive clinical program comprising five Phase 1 and 2
clinical studies, as well as Phase 3 pivotal efficacy and long-term
safety studies including both new-to-treatment patients as well as
patients switched from sublingual buprenorphine products.
Formulated with Camurus' FluidCrystal® injection depot
technology, CAM2038 is presented ready for use in pre-filled
syringes for weekly or monthly administration by a healthcare
professional as small dose volume subcutaneous injection through a
thin, 23-gauge needle. CAM2038 is 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] Lofwall MR, Walsh
SL, Nunes EV, Bailey GL, 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 Internal Medicine.
2018;178(6)764-773. doi:10.1001/jamainternmed.2018.1052
[2] Hedegaard H, Warner M, Minino AM. Drug overdose
deaths in the United States, 1999
2015. NCHS Data Brief. 2017;(273):1-8.
[3] Rudd RA, Seth P, David F, Scholl L. Increases in
drug and opioid-involved overdose deaths: United States, 2010-2015. MMWR Morb Mortal
Wkly Rep. 2016;65(5051):1445-1452.
[4] Strathdee SA, Beyrer C. Threading the needle:
how to stop the HIV outbreak in rural Indiana. N Engl J Med.
2015;373(5):397-399.
[5] Schwartz RP, McKenzie M, Rich JD. Opioid
addiction and incarceration: an overview. Med Health R I.
2007;90(5):157-158.
[6] Suryaprasad AG, White JZ, Xu F, et al. Emerging
epidemic of hepatitis C virus infections among young nonurban
persons who inject drugs in the United
States, 2006-2012. Clin Infect Dis.
2014;59(10):1411-1419
[7] Substance Abuse and Mental Health Services
Administration. Results from the 2015 National Survey on Drug Use
and Health: Table 5.2 A.
https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015.htm
[8] 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
[9] Center for Disease Control & Prevention
2018
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 1:10 pm CET
on 21 September 2018.
This information was brought to you by Cision
http://news.cision.comhttp://news.cision.com/camurus-ab/r/chmp-recommends-approval-of-buvidal---cam2038--for-the-treatment-of-opioid-dependence,c2624232
The following files are available for download:
http://mb.cision.com/Main/13456/2624232/913539.pdf
|
PDF
|
View original
content:http://www.prnewswire.com/news-releases/chmp-recommends-approval-of-buvidal-cam2038-for-the-treatment-of-opioid-dependence-300716780.html
SOURCE Camurus AB