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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR SUBLOCADE


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All Clinical Trials for Sublocade

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03604159 ↗ XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept Completed NYC Health + Hospitals Phase 4 2019-06-24 This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.
NCT03604159 ↗ XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept Completed New York University School of Medicine Phase 4 2019-06-24 This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.
NCT03604159 ↗ XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept Completed NYU Langone Health Phase 4 2019-06-24 This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.
NCT03744663 ↗ Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films Suspended Wake Forest University Health Sciences Phase 2 2022-06-01 While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. The FDA has recently approve a long acting subcutaneous injectable formulation of buprenorphine. This study aims to determine the feasibility of enrolling and randomizing patients seeking treatment at an outpatient substance abuse clinic to buprenorphine/naloxone films which dissolve under the tongue vs. long acting buprenorphine injection with all other treatment aspects held constant. The study also aims to determine the effectiveness of monthly injections of Sublocade® compared to daily oral Suboxone® SL therapy in the treatment of moderate to severe opioid use disorder after twenty-four weeks of treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sublocade

Condition Name

Condition Name for Sublocade
Intervention Trials
Opioid Use Disorder 5
Opioid-use Disorder 4
Opioid Dependence 2
Placebo 1
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Condition MeSH

Condition MeSH for Sublocade
Intervention Trials
Opioid-Related Disorders 14
Substance-Related Disorders 4
Disease 3
Opiate Overdose 2
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Clinical Trial Locations for Sublocade

Trials by Country

Trials by Country for Sublocade
Location Trials
United States 11
Australia 4
Canada 2
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Trials by US State

Trials by US State for Sublocade
Location Trials
New York 4
New Jersey 3
Virginia 2
Maryland 1
North Carolina 1
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Clinical Trial Progress for Sublocade

Clinical Trial Phase

Clinical Trial Phase for Sublocade
Clinical Trial Phase Trials
Phase 4 8
Phase 3 3
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Sublocade
Clinical Trial Phase Trials
Not yet recruiting 5
Completed 4
Recruiting 2
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Clinical Trial Sponsors for Sublocade

Sponsor Name

Sponsor Name for Sublocade
Sponsor Trials
Indivior Inc. 6
National Institute on Drug Abuse (NIDA) 3
Virginia Commonwealth University 2
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Sponsor Type

Sponsor Type for Sublocade
Sponsor Trials
Other 14
Industry 6
NIH 3
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SUBLOCADE: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to SUBLOCADE

SUBLOCADE, developed by Indivior PLC, is a groundbreaking treatment for moderate to severe Opioid Use Disorder (OUD). It is the first FDA-approved monthly injectable buprenorphine treatment, designed to enhance compliance and clinical outcomes in patients struggling with opioid addiction.

Clinical Trials and Efficacy

Phase 3 Clinical Trial Results

The pivotal Phase 3 clinical trial published in The Lancet demonstrated the efficacy, safety, and tolerability of SUBLOCADE. The trial involved 504 treatment-seeking adults with moderate or severe OUD, randomized to receive either SUBLOCADE (300/300 mg or 300/100 mg dosage regimens) or placebo over a 24-week period. All participants received weekly individual drug counseling and were initiated on transmucosal buprenorphine before the first SUBLOCADE injection[1][4].

  • Primary Efficacy Endpoint: Both SUBLOCADE dosage regimens met the primary efficacy endpoint, showing significantly higher mean percentage abstinence rates from opioid use compared to the placebo group (41.3% and 42.7% vs. 5.0% for placebo, P<0.0001)[1][4].
  • Treatment Success: The trial also showed that SUBLOCADE significantly increased the rate of treatment success, defined as ≥80% opioid abstinence during weeks 5-24, with 29.1% and 28.4% success rates for the 300/300 mg and 300/100 mg regimens, respectively, compared to 2.0% for the placebo group[1][4].

Safety and Tolerability

The safety profile of SUBLOCADE is consistent with that of transmucosal buprenorphine, with the addition of injection-site reactions seen in 16.5% of patients. The drug is a Schedule III controlled substance and is available only through a Risk Evaluation and Mitigation Strategy (REMS) program in conjunction with a complete Medication-Assisted Treatment (MAT) program[3].

Market Analysis

Current Market Position

SUBLOCADE has established itself as a leading treatment in the MAT market. Despite facing competition from other long-acting injectable (LAI) products, recent market data indicates that SUBLOCADE's market share is stabilizing at levels that maintain its leading position in the clinic[2][5].

Revenue Projections

  • Preliminary Q3 2024 Results: Indivior has revised its FY 2024 net revenue guidance for SUBLOCADE to $725m-$745m, reflecting faster-than-expected initial adoption of a competing LAI product and variability in funding among Criminal Justice System (CJS) accounts. Despite this, the Q3 2024 net revenue for SUBLOCADE is expected to grow 14% year-over-year[2][5].
  • Peak Net Revenue: The company remains confident in SUBLOCADE's potential, expecting peak net revenue to exceed $1.5 billion, although it no longer anticipates reaching a $1 billion net revenue run rate by the end of 2025[2][5].

Competitive Landscape

The MAT market is dynamic, with several products competing for market share. SUBLOCADE faces competition from products like Vivitrol and Suboxone, as well as new entrants such as Braeburn’s CAM-2038. However, SUBLOCADE's unique profile, including its once-monthly dosing and sustained buprenorphine exposure, continues to differentiate it in the market[3].

Future Enhancements

Indivior is actively seeking efficiencies to fuel SUBLOCADE's growth and support margins. Potential label updates in February 2025 are expected to improve both the patient and healthcare provider experience, further enhancing SUBLOCADE's market position[2][5].

Market Trends and Challenges

Adoption and Funding

The adoption of SUBLOCADE has been impacted by faster-than-expected initial adoption of competing LAI products, particularly among CJS accounts. This, combined with variability in funding timing, has resulted in net revenue below initial expectations. However, new CJS activations continue to grow, indicating ongoing demand for SUBLOCADE[2][5].

Trade Stocking and Market Adjustments

Lower-than-expected trade stocking levels in Q3 2024 have also affected SUBLOCADE's net revenue. As the US market adjusts to the presence of multiple LAI products, Indivior is focusing on strategies to maintain and grow SUBLOCADE's market share[2][5].

Patient and Healthcare Provider Experience

Compliance and Clinical Outcomes

SUBLOCADE's once-monthly injectable format enhances compliance by reducing the need for daily oral medications. This format also improves clinical outcomes by providing sustained buprenorphine exposure over the entire monthly period, which helps in controlling craving and withdrawal symptoms[1][3].

Safety Profile and REMS Program

The safety profile of SUBLOCADE, while generally consistent with transmucosal buprenorphine, includes the risk of injection-site reactions. The drug is only available through a REMS program, ensuring it is used in conjunction with a complete MAT program to minimize risks and maximize benefits[3].

Key Takeaways

  • Efficacy: SUBLOCADE has demonstrated significant efficacy in reducing opioid use and improving treatment success rates in clinical trials.
  • Market Position: Despite competition, SUBLOCADE maintains a leading position in the MAT market with a projected peak net revenue of over $1.5 billion.
  • Challenges: The product faces challenges from competing LAI products and variability in funding, but ongoing efforts to enhance the patient and healthcare provider experience are expected to support its growth.
  • Future Outlook: Potential label updates and continued growth in new market segments, such as CJS accounts, are anticipated to further solidify SUBLOCADE's market presence.

FAQs

What is SUBLOCADE and how is it administered?

SUBLOCADE is a monthly injectable buprenorphine treatment for moderate to severe Opioid Use Disorder (OUD). It is administered subcutaneously by a healthcare provider and requires initiation with a transmucosal buprenorphine product for at least seven days before the first injection[3].

What were the key findings of the Phase 3 clinical trial for SUBLOCADE?

The Phase 3 trial showed that SUBLOCADE significantly increased abstinence rates and treatment success compared to placebo, with mean percentage abstinence rates of 41.3% and 42.7% for the two dosage regimens, respectively[1][4].

How does SUBLOCADE compare to other MAT treatments?

SUBLOCADE offers a unique once-monthly dosing profile, enhancing compliance and reducing the risk of abuse and diversion. It has a safety profile consistent with transmucosal buprenorphine and is differentiated from other treatments like Vivitrol and Suboxone[3].

What are the current revenue projections for SUBLOCADE?

Indivior projects SUBLOCADE's FY 2024 net revenue to be between $725m-$745m, with a peak net revenue expectation of over $1.5 billion, although it no longer expects to reach a $1 billion net revenue run rate by the end of 2025[2][5].

What challenges is SUBLOCADE facing in the market?

SUBLOCADE faces competition from other LAI products, variability in funding among CJS accounts, and lower-than-expected trade stocking levels. However, Indivior is actively working to address these challenges and support SUBLOCADE's growth[2][5].

What future enhancements are expected for SUBLOCADE?

Potential label updates in February 2025 are expected to improve the patient and healthcare provider experience, further enhancing SUBLOCADE's market position[2][5].

Sources

  1. Indivior PLC. "The Lancet Publishes Phase 3 Results Demonstrating Efficacy, Safety and Tolerability of SUBLOCADE™ (Buprenorphine Extended-Release) Injection for Subcutaneous Use (CIII) in Patients with Moderate to Severe Opioid Use Disorder (OUD)." Press Release, February 19, 2019.
  2. Indivior PLC. "Indivior Provides Preliminary Q3 2024 Results; Updates FY 2024 Guidance; Group Continues to Expect SUBLOCADE Peak Net Revenue of >$1.5 Billion." Press Release, October 10, 2024.
  3. Clarivate. "Sublocade approval likely to be a game changer in the U.S. fight against opioid addiction." Blog Post, January 17, 2018.
  4. SUBLOCADE HCP. "Phase 3 Study | SUBLOCADE® (buprenorphine extended-release) injection for subcutaneous use (CIII)." Website.
  5. StockTitan. "Indivior Provides Preliminary Q3 2024 Results; Updates FY 2024 Guidance; Group Continues to Expect SUBLOCADE Peak Net Revenue of >$1.5 Billion." News Article, October 10, 2024.

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