Breakthrough Clinical Results
Indivior presented new data at the College on Problems of Drug Dependence (CPDD) meeting, showing that a higher dose (300mg) of SUBLOCADE (buprenorphine extended-release) may improve outcomes for opioid use disorder (OUD) patients with high fentanyl use. While not statistically significant across the entire study population, the 300mg dose showed clinically meaningful improvements in opioid abstinence in this subgroup. Additional research highlighted barriers to OUD treatment access among American Indian/Alaska Native populations, emphasizing the need for culturally appropriate care and improved access to medication for opioid use disorder (MOUD). No new safety concerns were identified with the higher SUBLOCADE dose.
Key Highlights
- Higher dose (300mg) of SUBLOCADE may improve outcomes for OUD patients with high fentanyl use.
- Significant reductions in opioid use observed with both 100mg and 300mg SUBLOCADE doses.
- Research highlights barriers to OUD treatment access in American Indian/Alaska Native populations.
- No new safety concerns identified with the 300mg SUBLOCADE dose.
Incidence and Prevalence
Global Burden of Opioid Use Disorder (OUD)
The global burden of OUD remains substantial. Here's a summary of the latest estimates based on available data:
-
2021 Estimates (GBD 2021 Study):
-
Total Cases: 16,164,876
-
Prevalence: 154.59 cases per 100,000 population (95% UI: 131.06-181.26)
-
Incidence: 1,942,525 cases (95% UI: 1,643,342-2,328,363)
-
Mortality: 99,555 deaths (95% UI: 92,948-108,050)
-
Disability-Adjusted Life Years (DALYs): 11,218,519 (95% UI: 9,188,658-13,159,551)
-
Regional Disparities: High-SDI regions, particularly High-income North America, exhibited the greatest burden.
-
Country-Specific Data (2021): The United States faced the most severe burden with the highest prevalence (2014.62 per 100,000), incidence (151.84 per 100,000), mortality (15.37 per 100,000), and DALYs (1594.63 per 100,000).
-
Demographic Trends: Males aged 20-39 years were most affected in 2021. However, forecasts indicate a significant increase in OUD burden among females over the next two decades, with prevalence and incidence projected to rise by 39% and 49%, respectively.
-
2017 Estimates (GBD 2017 Study):
-
Opioid Dependence: 40.5 million people (95% UI 34.3-47.9 million)
-
Overdose Deaths: 109,500 (105,800-113,600)
-
2010 Estimates (GBD Study):
-
Opioid Dependence: 15.5 million people globally (0.22%, 95% UI = 0.20-0.25%)
-
DALYs: 9.2 million globally (0.37% of global DALYs), a 73% increase from 1990.
It's important to note that estimates can vary depending on the methodology and data sources used in each study. The GBD studies provide the most comprehensive global estimates, while other studies offer insights into specific populations or time periods.
Unmet Needs and Target Populations in Opioid Use Disorder (OUD) Research (Past 3 Years)
Recent PubMed publications highlight several unmet needs and target populations in OUD research, emphasizing the need for improved access, tailored interventions, and addressing social determinants of health.
1. Expanding Access to Evidence-Based Treatment:
- Medications for Opioid Use Disorder (MOUD): Despite the proven effectiveness of MOUD (methadone, buprenorphine, naltrexone), access remains limited. Studies reveal substantial gaps between OUD prevalence and MOUD receipt, with estimates suggesting a majority of individuals with OUD do not receive it. Barriers include geographic disparities, provider stigma, and lack of training and resources. Innovations like telemedicine, bridge clinics, and expanded access models for methadone are being explored to address these barriers.
- Community Pharmacy-Based MOUD: Community pharmacies are recognized as underutilized resources for MOUD access. Policy changes to allow pharmacists to prescribe and dispense MOUD are advocated to improve access and address the opioid epidemic.
- Treatment for People Experiencing Homelessness (PEH): PEH face significant barriers to OUD treatment, including lack of stable housing, limited access to healthcare, and higher rates of co-occurring disorders. Low-barrier and targeted interventions, including housing interventions, are crucial for improving engagement and retention in treatment.
2. Tailoring Interventions to Specific Populations:
- Older Adults: OUD among older adults is a growing concern, with prevalence increasing significantly in recent years. This population may have unique treatment needs and co-morbidities that require specialized care.
- Pregnant Women: Opioid use during pregnancy necessitates a multidisciplinary approach, including universal screening, brief intervention, and referral for treatment. Long-term follow-up and support for both mother and infant are essential.
- Young Adults: Young adults with cancer report high levels of unmet psychological and informational needs related to opioid use for pain management. Regular screening and targeted support are needed in acute and follow-up care settings.
- Patients with Acute Pain: Even short courses of opioid therapy for acute pain can be challenging for patients. Improved patient education and engagement in their care plan are needed.
- Patients with Co-occurring Disorders: Co-occurring mental health and substance use disorders are common among individuals with OUD. Integrated treatment models that address both OUD and co-occurring conditions are essential for improving outcomes.
3. Addressing Social Determinants of Health:
- Social-Ecological Factors: A broader public health approach recognizes the influence of social and contextual factors on opioid misuse. Interventions should consider individual, interpersonal, community, and societal levels of influence.
- Unmet Social Needs: Addressing unmet social needs, such as housing, employment, and social support, is crucial for improving OUD treatment outcomes and reducing health disparities.
4. Improving Treatment Strategies:
- Addressing Opioid-Induced Hyperalgesia (OIH): OIH, a paradoxical increase in pain sensitivity caused by opioid exposure, can hinder pain management and contribute to opioid escalation. Research is focused on understanding the mechanisms of OIH and developing strategies for prevention and management.
- Developing Novel Non-Opioid Analgesics: The search for effective non-opioid pain relievers continues, with promising candidates including nerve growth factor (NGF) monoclonal antibodies, transient receptor potential vanilloid 1 (TRPV1) antagonists, and selective sodium channel blockers.
- Optimizing MOUD for High-Potency Synthetic Opioids (HPSOs): The emergence of HPSOs like fentanyl requires individualized strategies for buprenorphine initiation, stabilization, and long-term treatment. Proactive management of opioid withdrawal is essential.
5. Reducing Stigma and Misinformation:
- Patient and Provider Education: Stigma and misinformation about MOUD are prevalent among both patients and providers. Educational initiatives are needed to address these barriers and promote the use of evidence-based treatment.
By addressing these unmet needs and focusing on vulnerable populations, research can contribute to more effective prevention, treatment, and harm reduction strategies for OUD.
Drug used in other indications
While the provided text extensively discusses the use of SUBLOCADE (BUP-XR) for Opioid Use Disorder (OUD), it does not mention any other indications for which it is being trialled. The information focuses on its efficacy, safety, and various aspects of its use in OUD treatment, including different dosing regimens, patient experiences, and comparisons with other OUD medications like sublingual buprenorphine-naloxone and extended-release naltrexone.
One article mentions the use of buprenorphine (not specifically BUP-XR) in the treatment of chronic pain. However, this is in the context of switching patients from full opioid agonists to buprenorphine for pain management, not a separate trial for a new indication. Another article mentions buprenorphine's effectiveness in reducing cocaine self-administration, but this research is dated and predates the development of BUP-XR. It does not indicate ongoing trials of BUP-XR for cocaine dependence.
Therefore, based on the provided information, no trials for SUBLOCADE (BUP-XR) outside of OUD are mentioned.