Full Press Release Details
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, England and RICHMOND, Va. , Nov. 23, 2018 /PRNewswire/ -- Indivior PLC (LON: INDV) today announced that Health Canada has approved SUBLOCADE TM (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 buprenorphine-containing 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 provider 1 . 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 respectively 2 . 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 analogues 2 . Despite this growing crisis, barriers such as stigma continue to prevent patients from accessing treatment 3 .
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 period 2 .
In clinical trials, common adverse reactions (≥5% patients) included constipation, nausea, vomiting, headache, fatigue, insomnia, hepatic enzymes increased, and injection site pain and pruritus 1 . Injection site reactions were reported in 16% of the patients 1 . None of the injection site reactions were serious and one led to study treatment discontinuation 1 . SUBLOCADE has a SERIOUS WARNINGS AND PRECAUTIONS BOX. Serious harm or death could result if administered intravenously 1 .
This approval from Health Canada follows approval of SUBLOCADE by the U.S. Food and Drug Administration (FDA) on November 30, 2017 .
About SUBLOCADE TM
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:
Consult the product monograph for important information about:
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.
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.
SUBLOCADE is a trademark of Indivior UK Limited.
SOURCE Indivior PLC