TIDMINDV
RNS Number : 0485L
Indivior PLC
20 December 2018
Indivior Publishes Design and Patient Characteristics for
Real-World Study of Life Changes in People Treated with
SUBLOCADE(TM) (Buprenorphine Extended-Release) in Contemporary
Clinical Trials
RECOVER study designed to understand the long-term clinical,
environmental and socio-economic outcomes of SUBLOCADE treated
individuals
Slough, UK and Richmond, VA, 20 December 2018 - Indivior PLC
(LON: INDV) today announced the publication of the study design and
participant characteristics of the RECOVER (Remission from Chronic
Opioid Use-Studying Environmental and Socio-Economic Factors on
Recovery) study in Contemporary Clinical Trials. This multisite,
longitudinal observational study measures life changes, such as
quality of life and employment, in people with moderate to severe
opioid use disorder (OUD) for up to 24 months following
participation in a Phase 3 trial evaluating treatment with
once-monthly SUBLOCADE(TM) (buprenorphine extended-release)
injection for subcutaneous use (CIII) in combination with
counseling(1) .
"Real-world studies like RECOVER present an important
opportunity to better understand recovery in opioid use disorder,
how it evolves and the role of medications such as SUBLOCADE," said
Walter Ling, M.D., Professor Emeritus of Psychiatry and Founding
Director of the Integrated Substance Abuse Programs (ISAP),
University of California, Los Angeles, and lead study author. "In
treating moderate to severe opioid use disorder, we believe there
is an opportunity to drive change in not only traditional outcomes,
such as treatment retention and abstinence from opioids, but also
important patient-centered outcomes, such as family relationships,
integration to the community, healthcare costs, crime and
employment. This study is designed to help us assess these life
changes outside of the clinic."
The opioid epidemic in the United States is a public health
crisis that has grown(2) . In fact, in 2016, an average of 115
people died of opioid overdose each day - a number that is five
times higher than it was in 1999(3, 4) . Addiction can have a
devastating personal and societal impact for the affected
individuals, families and communities - it doesn't discriminate,
and it influences people from all walks of life(5,6) . Beyond
medical treatment, patients in treatment and their families require
support from community services and employers to promote a healthy
environment for recovery(7) .
"Quality care of patients suffering from opioid use disorder
requires the generation of data that not only address the clinical
efficacy and safety of a treatment, but also helps increase the
understanding of how patients are pursuing the life changes they
aspire to achieve, which is what true recovery is all about," said
Dr. Christian Heidbreder, Chief Scientific Officer, Indivior, Inc.
"We believe that the RECOVER study, which actively engages patients
in their real-world environment, will contribute to a better
understanding of how patients are navigating through their pathway
towards recovery, ultimately providing a more comprehensive
approach to the treatment of opioid use disorder and breaking down
barriers and misconceptions about this disease."
More information about the study design can be found in the
online publication of Contemporary Clinical Trials and the full
data will be published at a future date.
About the Study
The RECOVER (Remission from Chronic Opioid Use-Studying
Environmental and Socio-Economic Factors on Recovery) Study is a
multisite, non-interventional cohort study examining long-term
recovery in individuals with moderate to severe OUD who received at
least one dose of study treatment during the Phase 3 clinical
trials (NCT02357901 and NCT02510014) for SUBLOCADE(1) . Results are
being analyzed to understand the clinical, socio-economic and
environmental factors associated with continuous effects of
medication-assisted treatment (MAT) after a clinical trial(1) .
Participants (n=533) who were enrolled in the SUBLOCADE Phase 3
trials joined the RECOVER study after 28 days of completing or
terminating participation(1) . Demographics and psychosocial
characteristics of the RECOVER participants were compared with
those of a subset of respondents to the 2015 National Survey on
Drug Use and Health (NSDUH) in order to understand how this group
generalizes to the population of individuals with OUD in the United
States(1) .
The RECOVER study uses data from three main sources:
self-administered assessments from enrolled individuals, urine drug
screens (UDS) and data collected from several public sources(1) .
Recovery is examined over 24 months - the self-administered
assessment and UDS results are completed by participants every
three months over the course of this period(1) .
Linking the clinical trial data with real-world, post-trial
observational data provides a holistic view of both short- and
long-term outcomes. RECOVER's length of follow-up and frequency of
assessments present a unique opportunity to study how recovery
evolves in several ways, such as stability of the treatment effect,
factors related to relapse and the role of ongoing treatments
sought in the community(1) . These data will support analysis of
the societal effect of recovery progress made among individuals
affected by OUD, in terms of costs of healthcare use, crime and
employment(1) . Looking forward, future analyses of RECOVER data
will include longitudinal investigations of clinical, environmental
and socio-economic outcomes characterizing patient recovery.
About SUBLOCADE(TM)
SUBLOCADE is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of moderate to severe OUD in adult patients
who have initiated treatment with a transmucosal
buprenorphine-containing product, followed by dose adjustment for a
minimum of seven days(8) . It should be administered only by
healthcare providers and should be used as part of a complete
treatment program that includes counseling and psychosocial
support(8) . 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(8) . Common adverse reactions associated
with buprenorphine included constipation, nausea, vomiting,
abnormal liver enzymes, headache, sedation and somnolence(8) .
Injection site reactions were reported in 16.5 percent of patients
in Phase 3 studies(8) . Most of the injection site adverse
reactions (ADRs) were of mild to moderate severity(8) . None of the
injection site reactions were serious and one led to study
treatment discontinuation(8) .
SUBLOCADE has a BOXED WARNING and is available through
restricted distribution under the SUBLOCADE Risk Evaluation and
Mitigation Strategy (REMS) Program(8) . 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(8) . Moreover, certified
healthcare settings and pharmacies must not distribute, transfer,
loan or sell SUBLOCADE(8) .
For further product information, see full Prescribing
Information including BOXED WARNING and Medication Guide at
www.SUBLOCADE.com.
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(R) 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.
About Opioid Use Disorder (OUD)
Opioid use disorder (OUD), sometimes referred to as opioid
addiction, is a chronic disease(8) . According to DSM-5, "OUD is
characterized by signs and symptoms that reflect compulsive,
prolonged self-administration of opioid substances that are used
for no legitimate medical purpose or, if another medical condition
is present that requires opioid treatment, they are used in doses
greatly in excess of the amount needed for that medical
condition(9) ."
Based on 2016 data from the National Survey on Drug Use and
Health report, approximately 11.8 million Americans (age 12+ years)
engaged in misuse of opioids in the past year(10) . From 1999 to
2016, the rate of deadly prescription opioid overdoses increased
five-fold(4) . In 2016, an average of 115 people died of opioid
overdose each day in the United States(3) . In addition, in 2016,
935,000 adults used heroin and approximately 625,000 adults had a
heroin use disorder(10) . In 2015, opioids accounted for 70 percent
of the disease burden associated with drug use disorders
worldwide(5) .
About Indivior
Indivior is a global specialty pharmaceutical company with a
20-year legacy of leadership in patient advocacy and health policy
while providing education on evidence-based treatment models that
have revolutionized modern addiction treatment. Our vision is for
all patients around the world to have access to evidence-based
treatment for the chronic conditions and co-occurring disorders of
addiction. The name is the fusion of the words individual and
endeavor, and the tagline "Focus on you" makes the Company's
commitment clear. 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 strong 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 and schizophrenia.
Headquartered in the United States in Richmond, VA, Indivior
employs more than 900 individuals globally and its portfolio of
products is available in over 40 countries worldwide. Visit
www.indivior.com to learn more.
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 2018 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.
References
1. 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.
2. White House Council of Economic Advisers. (2017). The
Underestimated Cost of the Opioid Crisis. Retrieved from:
https://www.whitehouse.gov/sites/whitehouse.gov/files/images/The%20Underestimated%20Cost%20of%20the%20Opioid%20Crisis.pdf.
Accessed December 10, 2018.
3. Centers for Disease Control and Prevention. Understanding the Epidemic. Retrieved from: https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed December 10, 2018.
4. Centers for Disease Control and Prevention. (2017).
Prescription Opioid Overdose Data. Retrieved from:
https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed
December 10, 2018.
5. United Nations Office on Drugs and Crime, World Drug Report
2017 (ISBN: 978-92-1-148291-1, eISBN: 978-92-1-060623-3, United
Nations publication, Sales No. E.17.XI.6).
6. 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.
7. On file: Statement to the President's Commission on Combating
Drug Addiction and the Opioid Crisis. September 2017.
8. SUBLOCADE(TM) [Prescribing Information]. Indivior Inc., North Chesterfield, VA. March 2018.
9. American Psychiatric Association (2013). Diagnostic and
Statistical Manual of Mental Disorders (5th ed.). Arlington, VA:
American Psychiatric Publishing.
10. Substance Abuse and Mental Health Services Administration.
(2017). Key Substance Use and Mental Health Indicators in the
United States: Results from the 2016 National Survey on Drug Use
and Health (HHS Publication No. SMA 17-5044, NSDUH Series H-52).
Rockville, MD: Center for Behavioral Health Statistics and Quality,
Substance Abuse and Mental Health Services Administration.
Retrieved from:
https://www.samhsa.gov/data/report/key-substance-use-and-mental-health-indicators-united-states-results-2016-national-survey.
Accessed December 10, 2018.
Media Contacts
US
IndiviorMediaContacts@indivior.com
+1 804-594-0836
UK
Tulchan Communications
+44 207-353-4200
Investor Contact
Jason Thompson, Indivior
Vice President, Investor Relations
+1 804-379-1033
Jason.Thompson@indivior.com
SUBLOCADE, THE RECOVER STUDY and Recover Logo are trademarks of
Indivior UK Limited.
(c) Indivior PLC | INDIVIOR is a registered trademark of
Indivior UK Limited | All rights reserved
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END
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