Indivior receives approval for SUBUTEX® prolonged release solution for injection, 100mg and 300mg for substitution treatment of opioid dependence in Sweden
Slough, UK, 6 May 2020 – Indivior PLC (LON: INDV) announced today that the Swedish Medical Products
Agency (MPA) has approved Subutex® prolonged release solution for injection, 100 and 300mg for
substitution treatment of opioid dependence in adults and adolescents over 16 years of age within a
framework of medical, social and psychological treatment.1 This marks the first approval of Indivior’s
monthly long acting buprenorphine treatment for opioid dependence in Europe.
“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
Subutex® prolonged release solution for injection in Sweden is an important step, and we look forward to
continuing to partner with the local treatment community to help those with opioid use disorder.”
Subutex® prolonged release solution for injection contains buprenorphine with the Atrigel® Delivery
System, which isto be subcutaneously injected monthly in the abdominal area.2
It was designed to deliver consistent and sustained plasma levels of buprenorphine over the entire monthly dosing interval,
resulting in an occupancy of greater than 70% of the mu-opioid receptors for control of disease
symptoms.2,3
“This will provide patients with OUD, a chronic brain disease, an additional buprenorphine treatment
option. The expanded variety of treatments addresses the need to tailor the right treatment for the right
patient, which can help improve treatment retention. The effectiveness of buprenorphine is dosedependent, which we know correlates with plasma concentration and brain mu-opioid receptor
occupancy. Accordingly, this new treatment which delivers a stable dose of at least 2ng/mL of
buprenorphine over a full month provides a chance for long-term stability.“ says Professor Markus Heilig,
Linköping’s University Hospital
The approval is based on safety and efficacy data from a development programme, which included clinical
data of up to 12 months of treatment, in patients with opioid dependence.1
This medicine was first approved by the U.S. Food and Drug Administration (FDA) in November 2017 under
the name SUBLOCADE® for the treatment of moderate to severe opioid use disorder. It is currently
commercially available in the U.S., Australia, and Canada and has been recently approved in Israel under
the same name.
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 cooccurring 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 potentially
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.
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
+1 804-402-7123
Jason.Thompson@indivior.com