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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR SUBUTEX


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505(b)(2) Clinical Trials for Subutex

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00637000 ↗ Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone Completed Indivior Inc. Phase 2 2008-03-01 The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Subutex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000320 ↗ Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1 Completed National Institute on Drug Abuse (NIDA) Phase 1/Phase 2 1997-10-01 The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."
NCT00398008 ↗ HIV Risk Reduction and Drug Abuse Treatment in Iran Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 2004-10-01 A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.
NCT00398008 ↗ HIV Risk Reduction and Drug Abuse Treatment in Iran Withdrawn Yale University Phase 2 2004-10-01 A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Subutex

Condition Name

Condition Name for Subutex
Intervention Trials
Opioid-Related Disorders 9
Opiate Dependence 6
Drug Abuse 6
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Condition MeSH

Condition MeSH for Subutex
Intervention Trials
Opioid-Related Disorders 23
Substance-Related Disorders 13
Disease 7
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Clinical Trial Locations for Subutex

Trials by Country

Trials by Country for Subutex
Location Trials
United States 59
United Kingdom 2
Sweden 2
Austria 2
Germany 1
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Trials by US State

Trials by US State for Subutex
Location Trials
Pennsylvania 5
Maryland 5
Kentucky 4
Florida 4
Utah 4
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Clinical Trial Progress for Subutex

Clinical Trial Phase

Clinical Trial Phase for Subutex
Clinical Trial Phase Trials
Phase 4 7
Phase 3 9
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Subutex
Clinical Trial Phase Trials
Completed 28
Recruiting 5
Unknown status 3
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Clinical Trial Sponsors for Subutex

Sponsor Name

Sponsor Name for Subutex
Sponsor Trials
Indivior Inc. 12
National Institute on Drug Abuse (NIDA) 10
Johns Hopkins University 4
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Sponsor Type

Sponsor Type for Subutex
Sponsor Trials
Other 38
Industry 26
NIH 11
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SUBUTEX (Buprenorphine): Clinical Trials, Market Analysis, and Projections

Introduction to SUBUTEX (Buprenorphine)

SUBUTEX, a brand name for buprenorphine, is a medication widely used in the treatment of opioid use disorder (OUD). It is part of a broader class of medications known as medication-assisted treatment (MAT) and has been instrumental in helping individuals manage opioid addiction.

Clinical Trials Update

VA-BRAVE Study

One significant clinical trial involving buprenorphine is the VA-BRAVE study. This study compares the efficacy of oral sublingual (SL) buprenorphine with injectable subcutaneous buprenorphine. Participants are inducted on daily SL buprenorphine and then randomized to receive either a 28-day take-home supply of SL buprenorphine or injectable subcutaneous buprenorphine administered in the clinic. The study includes a 52-week intervention and 52-week active assessment period, followed by up to a 10-year passive follow-up[1].

Extended-Release Buprenorphine Trials

Another notable trial involves extended-release buprenorphine (BUP-XR). A pragmatic, parallel-group, open-label trial conducted in England and Scotland compared the effectiveness of monthly BUP-XR (Sublocade®) with standard-of-care (SoC) medications like liquid methadone or sublingual/transmucosal buprenorphine. The results showed that participants receiving BUP-XR had a higher mean number of days abstinent from opioids compared to those on SoC medications[4].

Market Analysis

Global Buprenorphine Market

The global buprenorphine market is experiencing significant growth driven by increasing approvals of buprenorphine treatments for OUD by regulatory authorities. As of 2023, the global buprenorphine market was valued at US$ 5.52 billion and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 14.9% during the forecast period. This growth is largely attributed to the approval of new formulations such as extended-release injections like Brixadi and Sublocade®[3].

Regional Market Dynamics

North America is currently the largest market for buprenorphine, while the Asia Pacific region is the fastest-growing market. This growth in the Asia Pacific is driven by increasing awareness of addiction recovery options and government initiatives to address the opioid crisis[2][5].

Market Size and Projections

The buprenorphine market, including naltrexone and buprenorphine combinations, is projected to expand significantly. By 2035, the naltrexone and buprenorphine market is estimated to reach USD 9.56 billion, growing at a CAGR of 8.65% between 2025 and 2035. The overall opioid use disorder treatment market is expected to reach USD 14.36 billion by 2035, with a CAGR of 9.75% between 2025 and 2035[2][5].

Drivers of Market Growth

Regulatory Approvals

Recent approvals by regulatory authorities, such as the U.S. Food and Drug Administration (FDA), have significantly boosted the market. For instance, the FDA approved Brixadi (buprenorphine) extended-release injection for subcutaneous use in 2023, which has expanded treatment options for OUD patients[3].

Increasing Prevalence of OUD

The rising prevalence of opioid use disorder globally is a major driver of the buprenorphine market. As more individuals seek treatment, the demand for effective medications like buprenorphine increases[5].

Advanced Formulations

The development of extended-release formulations, such as weekly and monthly injections, has enhanced treatment efficiency and patient compliance. These formulations, like Buvidal® and Sublocade®, offer more convenient and effective treatment options[4].

Telemedicine and Access

Telemedicine has played a crucial role in increasing access to buprenorphine treatment, especially in underserved areas. This has further driven the market growth by ensuring that more patients can receive necessary care[5].

Barriers to Growth

Stigma and Regulatory Complexity

Despite the growth, the market faces challenges such as stigma associated with opioid addiction and regulatory complexities. These barriers can limit access to treatment and affect market expansion[5].

Cost of Treatment

The cost of buprenorphine treatment, particularly for extended-release formulations, can be a significant barrier for many patients. This cost factor can impact market growth and patient adherence to treatment[5].

Expert Insights

"The increasing approval of buprenorphine treatment for opioid use disorder by regulatory authorities is expected to drive the growth of the global buprenorphine market over the forecast period." - Analysts at Coherent Market Insights[3].

Illustrative Statistics

  • By 2035, the naltrexone and buprenorphine market is estimated to reach USD 9.56 billion, growing at a CAGR of 8.65% between 2025 and 2035[5].
  • The global buprenorphine market is expected to exhibit a CAGR of 14.9% during the forecast period, reaching a value of over USD 5.52 billion in 2023[3].
  • In a clinical trial, participants receiving monthly extended-release buprenorphine (BUP-XR) had a higher mean number of days abstinent from opioids compared to those on standard-of-care medications[4].

Key Takeaways

  • Clinical Trials: Ongoing trials like VA-BRAVE and those involving extended-release buprenorphine are providing valuable insights into the efficacy and safety of buprenorphine treatments.
  • Market Growth: The global buprenorphine market is expected to grow significantly, driven by regulatory approvals, increasing prevalence of OUD, and advanced formulations.
  • Regional Dynamics: North America is the largest market, while the Asia Pacific region is the fastest-growing due to increasing awareness and government initiatives.
  • Barriers: Stigma, regulatory complexity, and the cost of treatment remain significant challenges to market growth.

FAQs

What is the current market size of the global buprenorphine market?

The global buprenorphine market was valued at US$ 5.52 billion in 2023[3].

What is the projected growth rate of the naltrexone and buprenorphine market?

The naltrexone and buprenorphine market is expected to grow at a CAGR of 8.65% between 2025 and 2035[5].

Which region is the fastest-growing market for buprenorphine?

The Asia Pacific region is the fastest-growing market for buprenorphine[2][5].

What are the main drivers of the buprenorphine market growth?

The main drivers include regulatory approvals, increasing prevalence of OUD, and the development of advanced formulations like extended-release injections[3][5].

What are the significant barriers to the growth of the buprenorphine market?

Significant barriers include stigma associated with opioid addiction, regulatory complexity, and the cost of treatment[5].

Sources

  1. UCSF Opioid Use Trial: Comparing Oral Buprenorphine and Injectable Subcutaneous Buprenorphine.
  2. Metatech Insights: Opioid Use Disorder Treatment Market Share & Size 2025-2035.
  3. Coherent Market Insights: Buprenorphine Market Size, Trends and Forecast to 2030.
  4. The Lancet: Superiority and cost-effectiveness of monthly extended-release buprenorphine.
  5. Metatech Insights: Naltrexone and Buprenorphine Market Size & Share 2025-2035.

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