RICHMOND, Va., Nov. 11, 2019 /PRNewswire/ -- Indivior PLC (LON:
INDV) announces the launch of a new direct-to-consumer (DTC)
advertising campaign, Keep Moving Towards Recovery, which
aims to heighten awareness of treatment with SUBLOCADE®
(buprenorphine extended-release) injection, for subcutaneous use
(CIII), as well as motivate those with moderate to severe opioid
use disorder (OUD) and those who care about them to seek help from
health care professionals to keep moving towards recovery.
SUBLOCADE 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.1
The Keep Moving Towards Recovery campaign is intended to
help reframe the perceptions of those struggling with moderate to
severe opioid addiction. Opioid addiction isn't a moral weakness,
it is a chronic disease called Opioid Use Disorder
(OUD)2 in which people develop a pattern of using
opioids that can lead to negative consequences.3 OUD may
affect the parts of the brain that control impulses, judgment, and
decision-making.3,4 Patients become trapped in a cycle
of opioid use, withdrawal, and cravings, which produces changes in
brain function that can reduce their ability to control their
use.3,5
"Although the medical community has recognized that opioid
addiction is a chronic disease, many people with OUD are still not
receiving appropriate, evidence-based therapies," said Gary Mendell, Founder and CEO of Shatterproof.
"Closing this gap and ensuring that people impacted have access to
the combination of counseling and medication for the addiction
treatment that is best for them is critical to reversing the tragic
trends across the country."
Medication-assisted treatment (MAT) combines medication and
counseling to treat both the physical and behavioral parts of
opioid addiction, with the goal of helping people achieve and
maintain recovery.3,4 The combination of medicine and
psychosocial therapy have been proven successful in treating OUD
and can even help extend recovery.3,4 In fact, MAT has
been shown to be more effective than either medication or
counseling alone.4
"While the Keep Moving Towards Recovery DTC campaign is
anticipated to help raise awareness of treatment with SUBLOCADE, we
also hope this campaign will contribute to the broader effort
underway to help people suffering from OUD to know that medication,
including counseling, is available to help them treat their
addiction and help them keep moving towards recovery," said
Shaun Thaxter, Chief Executive
Officer of Indivior. "We believe that those suffering from
moderate to severe opioid use disorder, and their loved ones
who are indirectly affected by this disease, should be aware
of all available treatment options so that they may discuss with
their treatment provider the appropriate option for them."
A common misconception about medications used to treat OUD is
that some of the medicines used simply substitute one drug for
another.6,7,8 However, these medications may restore
healthy brain function, which leads to improvements in behaviors
associated with addiction. Longer-term use of these medications is
associated with improved outcomes.9
Buprenorphine – which is one kind of medicine used to treat OUD
– has been shown to reduce craving, which can be one of the drivers
for continued opiate use.6,7,8 In a clinical study,
SUBLOCADE patients were 14x more likely to achieve treatment
success – 28% of people with SUBLOCADE plus counseling
compared to 2% of people with placebo plus counseling.1
In a 24-week study, treatment success was defined as opioid-free at
least 80% of the weeks in treatment. Opioid-free means urine sample
tested negative for illicit opioids plus no self-reported use of
opioids. Weeks were not always consecutive.1
"Despite robust evidence that medicines to treat OUD are safe
and effective,9 only 20% of people suffering from OUD
receive any kind of treatment2," said Mark Greenwald, Ph.D., Director, Substance Abuse
Research Division, Department of Psychiatry and Behavioral
Neurosciences, Wayne State University.
"This startling statistic highlights the need for more education
about evidence-based treatments for OUD that can help people more
effectively treat their illness and achieve recovery."
Every patient journey is different. Patients with moderate to
severe OUD should talk to their doctors to determine whether
medication-assisted treatment with SUBLOCADE is the right treatment
option for them. To learn more about different medications
and different treatment program directories and resources in
their area, people can visit the Substance Abuse and Mental Health
Services Administration (SAMHSA) website: www.samhsa.gov. People
can also visit www.inSupport.com to locate certified SUBLOCADE
providers in or near their community.
To view the direct-to-consumer (DTC) campaign, Keep Moving
Towards Recovery, please click here or visit
www.sublocade.com.
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.1
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.1 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.1 Most
of the injection site adverse reactions (ADRs) were of mild to
moderate severity.1 None of the injection site reactions
were serious, and one led to study treatment
discontinuation.1 SUBLOCADE has a BOXED WARNING and is
available through restricted distribution under the SUBLOCADE Risk
Evaluation and Mitigation Strategy (REMS) Program.1
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.1 Moreover, certified healthcare settings and
pharmacies must not distribute, transfer, loan or sell
SUBLOCADE.1
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
Prescription use of this
product is limited under the Drug Addiction Treatment Act.
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 body
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.
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)2 in which people
develop a pattern of using opioids that can lead to negative
consequences.3 Opioid addiction may affect the parts of
the brain that control impulses, judgment, and
decision-making.3,4 Patients become trapped in a cycle
of opioid use, withdrawal, and cravings, which produces changes in
brain function that can reduce their ability to control their
use.3,5
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.10 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.1
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.
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.
References
1. SUBLOCADE® [Prescribing Information].
Indivior Inc., North Chesterfield,
VA. October 2019.
2. 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.
3. 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.
4. 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.
5. Volkow ND, Koob GF, McLellan AT. Neurobiologic advances from
the brain disease model of addiction. N Engl J
Med. 2016;374:363-371.
6. U.S. Department of Health and Human (HHS), Services
Substance Abuse and Mental Health Services Administration Center
for Substance Abuse Treatment (SAMHSA). Tip 63: Medications for
Opioid Use Disorder. HHS Publication No. (SMA) 18-5063PT1,
Printed 2018
7. U.S. Department of Health and Human Services (HHS), National
Institute on Drug Abuse, National Institutes of Health. Medications
to Treat Opioid Use Disorder. Retrieved from:
https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-do-medications-to-treat-opioid-addiction-work.
Accessed on November 5, 2019.
8. U.S. Department of Health and Human Services (HHS), National
Institute on Drug Abuse, National Institutes of Health.
Effective Treatments for Opioid Addiction. November 2016.
9. National Academies of Sciences, Engineering, and Medicine.
2019. Medications for Opioid Use Disorder Save Lives.
Washington, DC: The National
Academies Press. http://doi.org/10.17226/25310.
10. 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 Behavioral 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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SOURCE Indivior