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Saturday, April 6, 2019

Indivior: New Study Data in Patients with Opioid Use Disorder

Injecting opioid users may benefit from higher maintenance dose of SUBLOCADE™ (buprenorphine extended-release), a once-monthly injection for the treatment of moderate to severe opioid use disorder Indivior also reports results of study showing that therapeutic concentrations of buprenorphine reduce the magnitude of respiratory depression caused by fentanyl.

Indivior PLC (LON: INDV) today announced data from two new studies: the first provides insights into dosing of once-monthly SUBLOCADE™ (buprenorphine extended-release) injection for subcutaneous use (CIII) for the treatment of moderate to severe opioid use disorder in patients who inject opioids, and the second study reports on the impact of therapeutic plasma concentrations of buprenorphine in inhibiting the respiratory depression caused by fentanyl. The results were reported at the 50th Annual Conference of the American Society of Addiction Medicine (ASAM) in Orlando, Florida and follow yesterday’s announcement of results from the RECOVER™ study and the 18-month long-term safety study.
We are generating data to help the healthcare community and others understand the unique challenges faced by patients with opioid use disorder and potential ways to overcome them,” said Christian Heidbreder, Ph.D., Chief Scientific Officer of Indivior. “Addressing this crisis, one patient at a time, means having the necessary information to make individualized decisions about optimal use of medically-assisted treatment to support each patient’s recovery—including proper dosing and length of treatment.”
Opioid injection users may benefit from higher SUBLOCADE maintenance dosesThis post-hoc analysis investigated patterns of abstinence in both injecting and non-injecting opioid users who participated in the SUBLOCADE Phase 3 double-blind, placebo controlled pivotal trial and the subsequent SUBLOCADE open-label long-term safety study (12 months of treatment). Abstinence was defined as negative urine samples plus negative self-reports of illicit opioid use.
Injecting opioid users (based on self-reports) treated with the SUBLOCADE maintenance dose regimen of 300 mg remained in treatment longer and had a higher study completion rate than those treated with the 100 mg maintenance dose. Furthermore, the mean percentage abstinence (Weeks 10–25) was higher among injecting users treated and maintained with SUBLOCADE 300 mg (58%) vs. those maintained with SUBLOCADE 100 mg (43%); the difference in group means was 15%. Among non-injecting users, the percentage with continuous abstinence was the same (28%) in both dose groups.
These findings are consistent with previous reports that injecting opioid drug users may benefit from higher doses of methadone or buprenorphine.1,2 “Indivior is planning additional studies to further characterize the patients for whom a higher maintenance dose of SUBLOCADE may be warranted,” said Dr. Heidbreder.

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