SLOUGH, England and RICHMOND,
Va, Dec. 10, 2019 /PRNewswire/
-- Indivior PLC (LON: INDV) today announced a new research
collaboration with Virginia Tech
extending the RECOVER (Remission from Chronic Opioid Use-Studying
Environmental and Socio-Economic Factors on Recovery) Study ™.
RECOVER is a multisite, non-interventional cohort study examining
long-term recovery in individuals with moderate to severe opioid
use disorder who received at least one dose of study treatment
during the SUBLOCADE Phase 3 clinical trials (NCT02357901 and
NCT02510014). ¹ The study design and participant characteristics of
the RECOVER study can be found in Contemporary Clinical
Trials.2 This study will be led by a team of researchers
at the Fralin Biomedical Research Institute at Virginia Tech
Carilion.
"The Virginia Tech-Indivior study is a powerful example of how
academia and industry can collaborate to address a major health
care problem that is causing tremendous hardship throughout
the United States, particularly
here in Virginia," said
Michael Friedlander, Vice President
for Health Sciences and Technology at Virginia
Tech and the Executive Director of the Fralin Biomedical
Research Institute. "Together we are determined to find
scientifically sound solutions to the opioid crisis."
The study will be carried out by a team of researchers led by
Warren Bickel, a Virginia Tech addiction researcher and professor at
the Fralin Biomedical Research Institute.
Researchers hope the extended study may also provide further
information to health care systems and policy-makers on how
successful treatment and long-term recovery can reduce the economic
burden of opioid use disorder. The scope and duration of
these assessments may also lead to important new insights into
theoretical models of recovery and allow researchers, clinicians,
and patients to more accurately characterize the process of
recovery, identify factors that promote or hinder success, and
develop new and personalized treatment strategies.
"We believe that this Virginia Tech-Indivior study, which will
actively engage patients in their real-world environment, will
contribute to a better understanding of how patients are able to
pursue the life changes they aspire to achieve, which is what true
recovery is all about" said Dr. Christian
Heidbreder, Chief Scientific Officer, Indivior, Inc.
About SUBLOCADE™
SUBLOCADE (buprenorphine extended-release) injection, for
subcutaneous use (CIII) is a prescription medicine used to treat
adults with moderate to severe addiction (dependence) to opioid
drugs (prescription or illegal) who have received an oral
transmucosal (used under the tongue or inside the cheek)
buprenorphine-containing medicine at a dose that controls
withdrawal symptoms for at least 7 days. SUBLOCADE is part of a
complete treatment plan that should include
counseling.3
The overall safety profile for
SUBLOCADE, given by a healthcare provider in clinical trials, was
consistent with the known safety profile of transmucosal
buprenorphine, except for injection site reactions.3
Adverse reactions commonly associated with SUBLOCADE (in ≥5% of
subjects) were constipation, headache, nausea, injection site
pruritus, vomiting, increased hepatic enzymes, fatigue and
injection site pain. Injection site reactions were reported in
16.5% of patients in Phase 3 studies.3 Most of the
injection site adverse reactions (ADRs) were of mild to moderate
severity.3 None of the injection site reactions were
serious, and one led to study treatment
discontinuation.3 SUBLOCADE has a BOXED WARNING and is
available through restricted distribution under the SUBLOCADE Risk
Evaluation and Mitigation Strategy (REMS) Program.3
Pursuant to the SUBLOCADE REMS, all healthcare settings and
pharmacies that order and dispense SUBLOCADE must be certified and
establish processes and procedures to verify the medication is
dispensed directly to a healthcare provider for administration by a
healthcare provider and is not dispensed directly to the
patient.3 Moreover, certified healthcare settings and
pharmacies must not distribute, transfer, loan or sell
SUBLOCADE.3
INDICATION AND USAGE
SUBLOCADE is indicated for the
treatment of moderate to severe opioid use disorder in patients who
have initiated treatment with a transmucosal
buprenorphine-containing product, followed by a dose adjustment
period for a minimum of seven days.
SUBLOCADE should be used as part of a complete treatment program
that includes counseling and psychosocial support.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF
SERIOUS HARM OR DEATH WITH INTRAVENOUS
ADMINISTRATION;
SUBLOCADE RISK
EVALUATION AND MITIGATION STRATEGY
- Serious harm or
death could result if administered intravenously. SUBLOCADE forms a
solid mass upon contact with bodily fluids and may cause occlusion,
local tissue damage, and thrombo-embolic events, including life
threatening pulmonary emboli, if administered intravenously.
- Because of the
risk of serious harm or death that could result from intravenous
self-administration, SUBLOCADE is only available through a
restricted program called the SUBLOCADE REMS Program. Healthcare
settings and pharmacies that order and dispense SUBLOCADE must be
certified in this program and comply with the REMS
requirements.
|
Prescription use of this product is limited under the Drug
Addiction Treatment Act.
CONTRAINDICATIONS
SUBLOCADE should not be administered
to patients who have been shown to be hypersensitive to
buprenorphine or any component of the ATRIGEL® delivery system.
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse:
SUBLOCADE contains buprenorphine, a Schedule III controlled
substance that can be abused in a manner similar to other opioids.
Monitor patients for conditions indicative of diversion or
progression of opioid dependence and addictive behaviors.
Respiratory Depression: Life threatening respiratory depression
and death have occurred in association with buprenorphine. Warn
patients of the potential danger of self-administration of
benzodiazepines or other CNS depressants while under treatment with
SUBLOCADE.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal
syndrome is an expected and treatable outcome of prolonged use of
opioids during pregnancy.
Adrenal Insufficiency: If diagnosed, treat with physiologic
replacement of corticosteroids, and wean patient off of the
opioid.
Risk of Opioid Withdrawal With Abrupt Discontinuation: If
treatment with SUBLOCADE is discontinued, monitor patients for
several months for withdrawal and treat appropriately.
Risk of Hepatitis, Hepatic Events: Monitor liver function tests
prior to and during treatment.
Risk of Withdrawal in Patients Dependent on Full Agonist
Opioids: Verify that patient is clinically stable on transmucosal
buprenorphine before injecting SUBLOCADE.
Treatment of Emergent Acute Pain: Treat pain with a non-opioid
analgesic whenever possible. If opioid therapy is required, monitor
patients closely because higher doses may be required for analgesic
effect.
ADVERSE REACTIONS
Adverse reactions commonly
associated with SUBLOCADE (in ≥5% of subjects) were constipation,
headache, nausea, injection site pruritus, vomiting, increased
hepatic enzymes, fatigue, and injection site pain.
For further product information, see full Prescribing
Information including BOXED WARNING and Medication Guide at
www.SUBLOCADE.com.
About Opioid Use Disorder
(OUD)
Opioid addiction isn't a moral weakness.
Opioid addiction is a chronic disease called Opioid Use Disorder
(OUD)4 in which people develop a pattern of using
opioids that can lead to negative consequences.5 Opioid
addiction may affect the parts of the brain that control impulses,
judgment, and decision-making.5,6 Patients become
trapped in a cycle of opioid use, which produces changes in brain
function that can reduce their ability to control their
use.5,7
In 2018, an estimated 10.3 million people aged 12 or older
misused opioids in the past year, including 9.9 million
prescription pain reliever misusers and 808,000 heroin users.
Approximately 506,000 people misused prescription pain relievers
and used heroin in the past year.8 SUBLOCADE is not
indicated for use in children younger than 18 years of age.
Buprenorphine, the active ingredient of SUBLOCADE can cause severe,
possibly fatal, respiratory depression in children who are
accidentally exposed to it.3
About Indivior
Indivior is a global pharmaceutical
company working to help change patients' lives by developing
medicines to treat addiction and serious mental illnesses. Our
vision is that all patients around the world will have access to
evidence-based treatment for the chronic conditions and
co-occurring disorders of addiction. Indivior is dedicated to
transforming addiction from a global human crisis to a recognized
and treated chronic disease. Building on its global portfolio of
opioid dependence treatments, Indivior has a pipeline of product
candidates designed to both expand on its heritage in this category
and address other chronic conditions and co-occurring disorders of
addiction, including alcohol use disorder. Headquartered in
the United States in Richmond, VA, Indivior employs more than 800
individuals globally and its portfolio of products is available in
over 40 countries worldwide. Visit www.indivior.com to learn more.
Connect with Indivior on LinkedIn by visiting
www.linkedin.com/company/indivior.
About Virginia
Tech
Dedicated to its motto, Ut Prosim (That I May
Serve), Virginia Tech pushes the
boundaries of knowledge by taking a hands-on, transdisciplinary
approach to preparing scholars to be leaders and
problem-solvers.
Since its founding as a land-grant college in 1872, Virginia Tech has grown to an enrollment of 35,000
and is the state's leading research institution. In Northern Virginia, the university is
developing a 1 million-square-foot Innovation Campus that will
become a global center of talent production and technology
excellence. In Roanoke, the Fralin
Biomedical Research Institute at VTC and the Virginia Tech Carilion
School of Medicine are a part of the VTC Academic Health Center.
The main campus is
Blacksburg, Virginia, while the
university's international presence is anchored by the Steger
Center for International Scholarship in Riva San Vitale, Switzerland.
Virginia Tech conducts more than
$530 million in research annually.
The university boasts world-class research institutes and
facilities — such as the Smart Road transportation research
testbed, and the Cube, a four-story theater and laboratory in the
Moss Arts Center.
Forward-Looking Statements
This press release contains
certain statements that are forward-looking and which should be
considered, amongst other statutory provisions, in light of the
safe harbor provisions of the United States Private Securities
Litigation Reform Act of 1995. By their nature, forward-looking
statements involve risk and uncertainty as they relate to events or
circumstances that may or may not occur in the future. Actual
results may differ materially from those expressed or implied in
such statements because they relate to future events.
Forward-looking statements include, among other things, statements
regarding the Indivior Group's financial guidance for 2019 and its
medium- and long-term growth outlook, its operational goals, its
product development pipeline and statements regarding ongoing
litigation.
Various factors may cause differences between Indivior's
expectations and actual results, including: factors affecting sales
of Indivior Group's products; the outcome of research and
development activities; decisions by regulatory authorities
regarding the Indivior Group's drug applications; the speed with
which regulatory authorizations, pricing approvals and product
launches may be achieved; the outcome of post-approval clinical
trials; competitive developments; difficulties or delays in
manufacturing; the impact of existing and future legislation and
regulatory provisions on product exclusivity; trends toward managed
care and healthcare cost containment; legislation or regulatory
action affecting pharmaceutical product pricing, reimbursement or
access; claims and concerns that may arise regarding the safety or
efficacy of the Indivior Group's products and product candidates;
risks related to legal proceedings, including the ongoing
investigative and antitrust litigation matters; the Indivior
Group's ability to protect its patents and other intellectual
property; the outcome of patent infringement litigation relating to
Indivior Group's products, including the ongoing ANDA lawsuits;
changes in governmental laws and regulations; issues related to the
outsourcing of certain operational and staff functions to third
parties; uncertainties related to general economic, political,
business, industry, regulatory and market conditions; and the
impact of acquisitions, divestitures, restructurings, internal
reorganizations, product recalls and withdrawals and other unusual
items.
This press release does not constitute an offer to sell or the
solicitation of an offer to subscribe for or otherwise acquire or
dispose of shares in the Company to any person in any jurisdiction
to whom it is unlawful to make such offer or solicitation.
THE RECOVER STUDY, RECOVER Logo and SUBLOCADE are trademarks of
Indivior UK Ltd. All rights reserved.
© Indivior PLC | INDIVIOR is a registered trademark of Indivior
UK Limited | All rights reserved
References
- Ling W., et al (2019). Remission from chronic opioid
use—studying environmental and socioeconomic factors on recovery
(RECOVER): Study design and participant characteristics.
Contemporary Clinical Trials. 76(1): 93-103. doi:
10.1016/j.cct.2018.11.015. Epub 2018 Nov 30.
- Ling, W., Nadipelli, V.R., Ronquest, N.A., Albright, V.A.,
Aldridge, A.P., Learned, S.M., Mehra, V., Heidbreder, C.
(2018). Remission from Chronic Opioid Use-Studying
Environmental and Socio-Economic Factors on Recovery (RECOVER):
Study Design and Participant Characteristics. Contemporary
Clinical Trials. 76(1): 93-103.
- SUBLOCADE™ [Prescribing Information]. Indivior Inc.,
North Chesterfield, VA.
October 2019.
- U.S. Department of Health and Human Services (HHS), Office of
the Surgeon General. Facing Addiction in America: The
Surgeon General's Report on Alcohol, Drugs, and
Health. Washington, DC: HHS, November 2016.
- U.S. Department of Health and Human (HHS), Services Substance
Abuse and Mental Health Services Administration Center for
Substance Abuse Treatment (SAMHSA). Medication-Assisted
Treatment for Opioid Addiction. HHS Publication No. (SMA)
09-4443, First printed 2009. Revised 2011.
- U.S. Department of Health and Human Services (HHS), National
Institute on Drug Abuse, National Institutes of Health. Drugs,
Brains, and Behavior: The Science of Addiction. HHS Publication
No. (SMA) 18-5063PT5, Printed 2018.
- Volkow ND, Koob GF, McLellan AT. Neurobiologic advances from
the brain disease model of addiction. N Engl J
Med. 2016; 374:363-371.
- Substance Abuse and Mental Health Services Administration.
Key substance use and mental health indicators in the United States: Results from the 2018
National Survey on Drug Use and Health. HHS Publication No.
PEP19-5068, NSDUH Series H-54. Rockville,
MD: Center for Behavioural Health Statistics and Quality,
Substance Abuse and Mental Health Services Administration.
Retrieved from https://www.samhsa.gov/data/. Accessed on
November 7, 2019.
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