Indivior details outcomes of opioid use disorder maintenance treatment

Indivior PLC (LON: INDV) today announced new data from a one-year analysis of the observational RECOVER™ (Remission from Chronic Opioid Use-Studying Environmental and Socio-Economic Factors on Recovery) study examining long-term recovery in individuals with opioid use disorder after transition from a pivotal Phase III clinical trial to a real-world setting.

• Among the 212 total participants in this one-year analysis of the RECOVER study, 133 (63%) continued some form of medication for opioid use disorder (MOUD) and 79 (37%) received no further MOUD after they completed participation in a phase III clinical trial of SUBLOCADE™ (buprenorphine extended-release) injection for subcutaneous use (CIII) for the treatment of moderate to severe to severe OUD.
• Of the 79 participants who did not continue MOUD, 45 (57%) were abstinent from opioids during the first 12-month RECOVER period, while 84 of the 133 participants (63.2%) who continued MOUD were abstinent. All participants had received 12-monthly doses of SUBLOCADE during phase III trials.

The results were reported at the 81^st Annual Scientific Meeting of the College on Problems of Drug Dependence (CPDD) in San Antonio, TX.

“These findings help us better understand the role of long-acting treatments, such as SUBLOCADE, in helping patients maintain long-term recovery from opioid use disorder,” said Walter Ling, M.D., Professor Emeritus of Psychiatry and Founding Director of the Integrated Substance Abuse Programs (ISAP) at UCLA, who reported the RECOVER study findings. “I am particularly excited about the data we are seeing from RECOVER because it is giving us new insights into how these patients with opioid use disorder are managing in the real world after clinical trial participation.”

RECOVER is measuring abstinence in three ways: negative urine drug screens, no self-reported past week use and a combination of both (i.e., having both a negative urine drug screen and no self-reported opioid use), which is the measure reported here.

The RECOVER study is also tracking patient success beyond measuring opioid abstinence. Participants who did not continue MOUD experienced less drug craving than participants who continued MOUD, which investigators suggest may indicate less pre-occupation with drug memories and successful avoidance of drug triggers in the no MOUD group. Participants in both groups reported similar rates of psychological distress and depression, as well as functional impairment like the inability to meet daily family, work or school responsibilities, which are common challenges for patients recovering from opioid use disorder.

The RECOVER (Remission from Chronic Opioid Use-Studying Environmental and Socio-Economic Factors on Recovery) study is a multisite, non-interventional cohort study examining long-term recovery in individuals with moderate to severe opioid use disorder who received at least one dose of study treatment during the Phase III clinical trials (NCT02357901 and NCT02510014) for SUBLOCADE.¹ Results are being analyzed to understand the clinical, socio-economic and environmental factors associated with continuous effects of MOUD after a clinical trial.¹ 

Participants (n=533) were eligible to join the RECOVER study 28 days after completing or terminating participation in the SUBLOCADE Phase III trials.¹ The RECOVER study uses data from three main sources: self-administered assessments from enrolled individuals, urine drug screens (UDS) and data collected from several public sources.¹Recovery is examined over 24 months – the self-administered assessment and UDS results are completed by participants every three months over the course of this period.¹

“Our investment in the RECOVER study reflects our commitment to tracking patient progress in the short-, medium- and long-term to continue to empower patients and providers with information that helps them treat their opioid use disorder,” said Christian Heidbreder, Ph.D., Chief Scientific Officer of Indivior.

Post-hoc analysis evaluates abstinence responses to monthly SUBLOCADE maintenance doses of 300 mg versus 100 mg in people who inject opioids

Indivior presented new post-hoc analyses from SUBLOCADE 24-week Phase III clinical trials suggesting that people with moderate to severe opioid use disorder who inject opioids may benefit from the higher 300 mg once-monthly SUBLOCADE maintenance dose. SUBLOCADE is administered as two initial monthly doses of 300 mg followed by monthly maintenance doses of either 100 mg (300/100 mg) or 300 mg (300/300 mg).

Non-injecting opioid users achieved maximal response at buprenorphine plasma concentrations of 2.5 to 3 ng/mL, while injecting opioid users achieved maximal response at concentrations closer to 6 ng/mL. These laboratory findings aligned with improved clinical outcomes showing a significantly higher mean percentage of abstinence among injecting users maintained on the 300 mg dose (60.1%) compared to those maintained on the 100 mg dose (45.3%) for a risk-adjusted difference of just under 15%.

“The SUBLOCADE dosing regimens were designed to deliver sustained buprenorphine plasma concentrations of at least 2 ng/mL that are needed to block the subjective effects of opioids in most subjects,” according to Dr. Heidbreder, “But years of experience working to improve outcomes for patients with opioid use disorder have taught us that treatment options are not one-size-fits-all. Indivior is planning additional studies to further characterize the patients who may benefit from the higher maintenance dose of SUBLOCADE.”

https://www.biospace.com/article/releases/new-data-from-the-recover-study-reports-on-abstinence-drug-craving-and-psychosocial-outcomes-in-people-with-opioid-use-disorder-following-transition-from-a-clinical-trial-to-the-real-world-setting/