Indivior Announces Publication of Data Showing Psychosocial Benefits from a 4-year Post-Clinical Trial Outcomes Study
Published in Drug and Alcohol Dependence, patients in the long-term RECOVER observational study following participation in an extended-release buprenorphine injections treatment trial reported high levels of psychosocial functioning and abstinence
Richmond, VA, May 26, 2022 – Indivior PLC (LON: INDV) announced today a new analysis of a long-term study highlighting the nature of opioid use disorder (OUD) treatment and recovery. The study titled “Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study” was published in the May 2022 issue of Drug and Alcohol Dependence (DAD), a peer-reviewed journal.
Individuals who participated in the RECOVER Study (Remission from Chronic Opioid Use-Studying Environmental and SocioEconomic Factors on Recovery; NCT03604861)1 were examined for long-term recovery following their transition from long-acting buprenorphine subcutaneous injection clinical trials into a real-world setting.
Study results include:
- After 12-months in the original RECOVER study, abstinence was over 62 percent at each visit, with over 50 percent of participants reporting sustained abstinence for the full 12-month period.2 In this follow-up study, high opioid abstinence rates were also reported (55 percent from the last RECOVER study assessment and 69 percent over the past 30 days).3
- Elevated psychosocial functioning was reported at longer term recovery from OUD with 68.1 percent of patients reporting minimal depression and 90.3 percent reporting no serious psychological distress, and low levels of functional impairment (4.02 [7.17]; range: 0-30; SDS)3.
- Positive associations were reported between depression and past 30-day opioid misuse. Higher odds of misuse were also associated with psychological distress, delay discounting, opioid craving, opioid withdrawal and OUD symptoms.3
- Lower odds of misuse were associated with higher quality of life and treatment effectiveness.3
Of the 533 participants who enrolled in the RECOVER study and 216 completed this follow-up study, averaging 4.2 years after their original participation in the clinical program.3 Similar to other long-term studies, more than half of the patients dropped out between the original RECOVER study and the follow-up study.4 Among the 216 who completed the follow-up study, 56% were using at least one type of substance use disorder treatment and 35.2% specifically used Medications for OUD (MOUD).3
“The RECOVER™ study continues to bridge the knowledge gap in the recovery journey in patients who received up to 18 months of extended-release buprenorphine in a controlled clinical trial setting,” said Dr. Warren K. Bickel, principal investigator and research professor at Fralin Biomedical Research Institute at Virginia Tech Carilion. “We were pleased to see that the majority of patients enrolled in RECOVER-LT, more than 4 years after their participation in the clinical trial, were able to maintain high levels of psychosocial functioning and sustain their recovery.”
RECOVER-LT assessed a broad range of outcomes relevant to OUD and allowed for a multidimensional understanding of recovery for individuals who received MOUD. These results highlight the high levels of psychosocial functioning, improvements in lifestyle, health, and community measures, and high rates of abstinence from opioids among long-term RECOVER participants.
About SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.
SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.
HIGHLIGHTED SAFETY INFORMATION
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION;
SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY
- Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously.
- Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.
Prescription use of this product is limited under the Drug Addiction Treatment Act.
CONTRAINDICATIONS
SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.
Opioids can cause sleep-related breathing disorders e.g., central sleep apnea (CSA), sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. Consider decreasing the opioid using best practices for opioid taper if CSA occurs.
Strongly consider prescribing naloxone at SUBLOCADE initiation or renewal because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Educate patients and caregivers on how to recognize respiratory depression and how to treat with naloxone if prescribed.
Risk of Serious Injection Site Reactions: The most common injection site reactions are pain, erythema and pruritis with some involving abscess, ulceration, and necrosis. The likelihood of serious injection site reactions may increase with inadvertent intramuscular or intradermal administration.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy.
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.
Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.
Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE.
Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.
ADVERSE REACTIONS
Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.
For more information about SUBLOCADE, the full Prescribing Information including BOXED WARNING, and Medication Guide, visit www.sublocade.com.
About Opioid Use Disorder (OUD)
Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences.5 OUD may affect the parts of the brain that are necessary for life-sustaining functions.5
About Indivior
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD) 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 co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD 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 SUD, including alcohol use disorder and cannabis use disorder. 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. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
Media Contacts:
UK
Tulchan Communications
+44 207-353-4200
US
IndiviorMediaContacts@indivior.com
+1 804-594-0836
Investor Contact:
Jason Thompson
Vice President, Investor Relations
Indivior PLC (LON: INDV)
Mobile: 804-402-7123
References:
- Ling W, Nadipelli V, Ronquest N, Albright V, Aldridge A, Learned S, Mehra V, Heidbreder C (2019) Remission from Chronic Opioid Use—Studying Environmental and Socio-economic Factors on Recovery (RECOVER): study design and participant characteristics. Contemp. Clin. Trials, 76: 93-103. https://doi.org/10.1016/j.cct.2018.11.015
- Ling, W. et al. (2020). Recovery from opioid use disorder (OUD) after monthly long-acting buprenorphine treatment: 12-month longitudinal outcomes from RECOVER, an observational study. J Addict Med;14(5):e233-e240. https://doi.org/10.1097/ADM.0000000000000647
- Craft, W. H. et al. (2022). Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug and Alcohol Dependence. Published online March 9, 2022
https://doi.org/10.1016/j.drugalcdep.2022.109389 - Nadipelli V.R. (2019). What is the optimal duration of treatment in opioid use disorder? Presented at Addictions Toxicomanies Hèpatitties Sida (ATHS), Biarritz, France. [Data on File]
- U.S. Department of Health and Human Services (HHS), National Institute on Drug Abuse, National Institutes of Health. Drugs, Brains, and Behavior: The Science of Addiction. HHS Publication No. (SMA) 18-5063PT5, Printed 2018.