Indivior Announces Health Canada Approval of SUBLOCADE (Buprenorphine Extended-Release) Injection for Patients with Moderate to Severe Opioid Use Disorder
SUBLOCADE is the first and only once-monthly injectable buprenorphine formulation approved in
Canada for the management of moderate to severe opioid use disorder
Slough, UK and Richmond, VA, 23 November 2018 ? Indivior PLC (LON: INDV) today announced that
Health Canada has approved SUBLOCADETM (buprenorphine extended-release) injection for
subcutaneous use, for the management of moderate to severe opioid use disorder (OUD) in adult
patients who have been inducted and clinically stabilized on a transmucosal buprenorphinecontaining product. SUBLOCADE should be used as part of a complete treatment plan that includes
counseling and psychosocial support, and must only be administered once a month, subcutaneously
in the abdominal region by a healthcare provider1
. In Canada, SUBLOCADE will be marketed by
Indivior Canada Ltd., and will be available by the second half of 2019.
?We are committed to helping the patients, families and communities impacted by the opioid
epidemic around the world,? said Shaun Thaxter, Chief Executive Office of Indivior. ?The approval of
SUBLOCADE in Canada is an important milestone, and we look forward to continuing to partner with
the Canadian treatment community to help those with opioid use disorder.?
Illicit opioid use in Canada is a national public health crisis that continues to grow, with 3,005 and
3,996 apparent opioid-related deaths in 2016 and 2017 respectively2
. From January to March 2018,
there were at least 1,036 apparent opioid-related deaths; of these deaths, 94% were accidental and
73% involved fentanyl or fentanyl analogues2
. Despite this growing crisis, barriers such as stigma
continue to prevent patients from accessing treatment3
.
SUBLOCADE, in combination with counseling and psychosocial support, is a once-monthly
medication-assisted treatment (MAT) that contains buprenorphine, a mu-opioid receptor agonist. It
uses the ATRIGEL? Delivery System and solidifies on contact with bodily fluids to deliver
buprenorphine over the one month period2
.
In clinical trials, common adverse reactions (=5% patients) included constipation, nausea, vomiting,
headache, fatigue, insomnia, hepatic enzymes increased, and injection site pain and pruritus1
.
Injection site reactions were reported in 16% of the patients1
. None of the injection site reactions
were serious and one led to study treatment discontinuation1
. SUBLOCADE has a SERIOUS
WARNINGS AND PRECAUTIONS BOX. Serious harm or death could result if administered
intravenously1
.
This approval from Health Canada follows approval of SUBLOCADE by the U.S. Food and Drug
Administration (FDA) on November 30, 2017.
About SUBLOCADETM
In Canada, SUBLOCADE is indicated for the management of moderate to severe opioid use disorder
in adult patients who have been inducted and clinically stabilized on a transmucosal buprenorphine-
containing product. SUBLOCADE should be used as part of a complete treatment plan that includes
counselling and psychosocial support. SUBLOCADE must only be administered subcutaneously in the
abdominal region by a healthcare provider.
Contraindicated in:
? Patients who are hypersensitive to this drug or any ingredient in the formulation, including
any non-medicinal ingredient, or any component of the ATRIGEL? Delivery System.
? Patients with severe respiratory insufficiency: e.g., acute or severe bronchial asthma, chronic
obstructive airway, status asthmaticus, acute respiratory depression and/or cor pulmonale.
? Patients with severe hepatic impairment.
? Patients with acute alcoholism or delirium tremens.
? Patients with known or suspected mechanical gastrointestinal obstruction (e.g., bowel
obstruction or strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of
any type).
? Patients with suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
? Patients with severe central nervous system (CNS) depression, increased cerebrospinal or
intracranial pressure, and head injury.
? Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy).
? Patients with convulsive or seizure disorders.
? Congenital Long QT Syndrome or QT prolongation at baseline.
? Uncorrected hypokalemia, hypomagnesemia, or hypocalcemia.
Consult the product monograph for important information about:
? Serious warnings and precautions regarding incorrect administration, limitations of use,
addiction, abuse and misuse, use during pregnancy, interaction with alcohol, neonatal opioid
withdrawal syndrome, interaction with other central nervous system depressants and
cardiac.
? Other warnings and precautions regarding intravenous administration, risk of misuse, abuse
or diversion, risk of tissue damage, adrenal insufficiency, hypotension, QTc prolongation,
dependence and risk of withdrawal with discontinuation, driving hazardous machinery,
circumstances when cerebrospinal pressure may be increased, effects in acute abdominal
conditions, elevation of intracholedochal pressure, hepatitis and hepatic events, monitoring
and laboratory tests, peri-operative considerations, risk of respiratory and central nervous
system depression, serotonin syndrome, reproduction, function and fertility, general
precautions, unintentional pediatric exposure, use in opioid-na?ve patients, pregnancy,
labour or delivery, nursing women and geriatrics.
? Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.
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 longterm 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. SUBLOCADETM [Canada Prescribing Information]. Indivior UK Limited.
2. Special Advisory Committee on the Epidemic of Opioid Overdoses. National report: Apparent
opioid-related deaths in Canada (January 2016 to March 2018) Web-based Report. Ottawa:
Public Health Agency of Canada; September 2018.
3. Government of Canada. Together, we can stop the cycle of stigma. Retrieved from:
https://www.canada.ca/en/health-canada/services/video/stop-the-cycle-of-stigma.html.
Accessed September 2018.
Media Contacts
Jonathan Sibun
Tulchan Communications
+44 207-353-4200
U.S. Media Inquiries
IndiviorMediaContacts@indivior.com
+1 804-594-0836
Investor Contact
Jason Thompson, Indivior
Vice President, Investor Relations
Jason.Thompson@indivior.com
+1 804-423-8916
SUBLOCADE is a trademark of Indivior UK Limited.
? Indivior PLC | INDIVIOR is a registered trademark of Indivior UK