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April 8, 2019

Indivior reports positive data for opioid use disorder therapy

Specialty pharmaceutical firm Indivior has reported positive results from two clinical trials, RECOVER and an 18-month safety study, of Sublocade to treat moderate to severe opioid use disorder.

Specialty pharmaceutical firm Indivior has reported positive results from two clinical trials of Sublocade to treat moderate to severe opioid use disorder.

Sublocade is an extended release formulation of buprenorphine intended for subcutaneous use.

Results from the Phase III RECOVER study showed that 75% of the subjects treated with 12 once-monthly doses of Sublocade were abstinent from illicit opioids one year later.

Abstinence was assessed through self-report confirmed by urine drug test. The trial involved a total of 533 participants, of which 80% completed the one-year survey.

The 18-month safety study did not reveal any new safety concerns in the Sublocade arm of 166 subjects with moderate to severe opioid use disorder.

“These 18-month study results support the use of Sublocade as an effective and well-tolerated treatment.”

The overall safety profile of the medication was found to be consistent with that of transmucosal buprenorphine, except mild to moderate injection-site reactions.

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In addition, the frequency and severity of treatment-emergent adverse events (TEAEs) was observed to decrease over time.

According to data from a retrospective analysis of the study, the rates of abstinence increased from 36%-53% at week one to 82%-93% at 18 months.

Findings from both the studies were presented at the 50th Annual Conference of the American Society of Addiction Medicine (ASAM) in Orlando, Florida, US.

Indivior chief medical officer Anne Andorn said: “These 18-month study results support the use of Sublocade as an effective and well-tolerated treatment for patients with opioid use disorder.

“It can be very difficult for patients to stop using illicit opioids, they and their healthcare providers should have access to a range of evidence-based treatment options, including long-acting injectables, to help patients continue to stay away from the use of illicit opioids.”

Apart from the long-term abstinence, the RECOVER trial is monitoring patient-centred outcomes such as the impact of Sublocade therapy on employment and healthcare costs, among others. This data will be reported in December this year.

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