CLINICAL TRIALS PROFILE FOR BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

505(b)(2) Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride

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.

All Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000243 ↗	Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone	Terminated	National Institute on Drug Abuse (NIDA)	N/A	2002-09-01	Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.
NCT00000298 ↗	Buprenorphine Combination Tablet Feasibility - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-08-01	The purpose of this study is to determine target dose range of buprenorphine/naloxone combination tablet that provides therapeutic response in opiate addicts with low to moderate dependence, and to identify appropriate initial induction dose in opiate addicts with low to moderate dependence."
NCT00000326 ↗	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1997-04-01	The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
NCT00000326 ↗	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1	Withdrawn	University of Colorado, Denver	Phase 2	1997-04-01	The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
NCT00000327 ↗	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1997-06-01	The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.
NCT00000327 ↗	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2	Withdrawn	University of Colorado, Denver	Phase 2	1997-06-01	The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.

Clinical Trial Conditions for buprenorphine hydrochloride; naloxone hydrochloride

Condition Name

Condition Name for buprenorphine hydrochloride; naloxone hydrochloride
Intervention	Trials
Opioid-Related Disorders	31
Opioid Use Disorder	25
Opioid Dependence	20
Opioid-use Disorder	16

Condition MeSH

Condition MeSH for buprenorphine hydrochloride; naloxone hydrochloride
Intervention	Trials
Opioid-Related Disorders	107
Substance-Related Disorders	25
Heroin Dependence	15
Disease	15

Clinical Trial Locations for buprenorphine hydrochloride; naloxone hydrochloride

Trials by Country

Trials by Country for buprenorphine hydrochloride; naloxone hydrochloride
Location	Trials
United States	252
Canada	9
Norway	6
Australia	4
Taiwan	3

Trials by US State

Trials by US State for buprenorphine hydrochloride; naloxone hydrochloride
Location	Trials
New York	27
Maryland	25
California	22
Pennsylvania	12
Florida	12

Clinical Trial Progress for buprenorphine hydrochloride; naloxone hydrochloride

Clinical Trial Phase

Clinical Trial Phase for buprenorphine hydrochloride; naloxone hydrochloride
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	2
PHASE2	1

Clinical Trial Status

Clinical Trial Status for buprenorphine hydrochloride; naloxone hydrochloride
Clinical Trial Phase	Trials
Completed	75
Recruiting	21
Not yet recruiting	15

Clinical Trial Sponsors for buprenorphine hydrochloride; naloxone hydrochloride

Sponsor Name

Sponsor Name for buprenorphine hydrochloride; naloxone hydrochloride
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	48
Indivior Inc.	13
University of California, Los Angeles	10

Sponsor Type

Sponsor Type for buprenorphine hydrochloride; naloxone hydrochloride
Sponsor	Trials
Other	152
Industry	53
NIH	51

Clinical Trials Update, Market Analysis, and Projection for Buprenorphine Hydrochloride/Naloxone Hydrochloride

Last updated: October 29, 2025

Introduction

The combination of Buprenorphine Hydrochloride and Naloxone Hydrochloride (hereafter BUP/NAL), has become a cornerstone in the opioid dependency treatment landscape. Marketed under brand names such as Suboxone, this medication is critical in addressing the opioid crisis globally. This article provides an in-depth review of recent clinical trials, analyzes the current market landscape, and offers a future projection grounded in industry data and trends.

Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past two years, clinical research on BUP/NAL has primarily focused on optimizing treatment efficacy, minimizing misuse, and expanding indications. Major trials include:

• Efficacy in Opioid Use Disorder (OUD):
  Multiple Phase III trials validate the drug’s efficacy. A notable study by the National Institute on Drug Abuse (NIDA) demonstrated that BUP/NAL significantly reduces cravings and withdrawal symptoms, facilitating sustained abstinence when combined with behavioral therapies [1].

• Extended-Release Formulations:
  Several studies, including those published in The Lancet (2022), evaluate the safety and efficacy of once-monthly subcutaneous extended-release formulations. Results indicate comparable efficacy to daily sublingual administration, improving adherence and reducing diversion risks [2].

• Safety Profile and Misuse Prevention:
  Trials confirm that Naloxone inclusion effectively deters intravenous misuse. Data from a 2021 randomized controlled trial show a sharp decline in misuse instances among participants using BUP/NAL versus BUP alone [3].

• Special Populations and Comorbidities:
  Recent trials extend to pregnant women and adolescents. Emerging evidence suggests safe use with careful monitoring, although further research remains necessary for these cohorts [4].

Current Clinical Trials Pipeline

Numerous ongoing trials are exploring:

• Comparisons between BUP/NAL and other MAT options such as Methadone and extended-release naltrexone.
• Long-term safety assessments.
• Efficacy of BUP/NAL in treating opioid addiction linked to synthetic opioids like fentanyl.

ClinicalTrials.gov lists approximately 25 active studies focusing on BUP/NAL, indicating sustained scientific interest.

Market Analysis

Market Size and Growth Trends

The global opioid dependence treatment market, valued at approximately USD 2.2 billion in 2022, is projected to grow at a CAGR of around 5.2% through 2030, driven by the increasing prevalence of opioid use disorder (OUD) and expanding regulatory acceptance of BUP/NAL [5].

Key Market Drivers

• Rising Opioid Crisis:
  The CDC reports over 100,000 drug overdose deaths in the US in 2021, primarily linked to opioids, catalyzing demand for effective MAT options [6].

• Regulatory Approvals and Policy Support:
  Governments worldwide are easing regulations to improve access. The U.S. Drug Enforcement Administration (DEA) has expanded prescribing rights for certified physicians, facilitating broader utilization.

• Designated Favorite for Prescribing Physicians:
  BUP/NAL's safety profile and misuse-deterrent properties make it preferred over methadone in outpatient settings, especially in primary care.

Market Players and Competitive Landscape

Major manufacturers include:

• Indivior PLC:
  Pioneers with Suboxone, with a robust R&D pipeline and global distribution network.

• Teva Pharmaceutical Industries:
  Offers generic BUP/NAL, capturing price-sensitive markets.

• Mundipharma:
  Engages in branded formulations in certain regions.

Emerging companies are developing novel formulations, including buccal films and depot injections, aiming to improve compliance and diversion control.

Regional Market Dynamics

• North America:
  Dominates the market with over 70% share, driven by high OUD prevalence and supportive policies.

• Europe:
  Growing adoption, with increasing reimbursement coverage and regulatory approvals.

• Asia-Pacific:
  Exhibiting rapid growth potential due to expanding healthcare infrastructure and rising awareness, though still in nascent stages regarding widespread adoption.

Barriers and Challenges

• Regulatory Hurdles:
  Variability in approval processes may delay entry into certain markets.

• Stigma and Access Issues:
  Social stigma associated with MAT and logistical barriers limit treatment access.

• Pricing and Reimbursement:
  Cost remains a barrier in low- and middle-income settings.

Market Projection

Short to Medium-Term Outlook (2023–2027)

• Growth Trajectory:
  The market is expected to expand at a CAGR of approximately 6%, with revenues exceeding USD 3.8 billion by 2027.

• Key Growth Areas:
  Increased adoption of long-acting formulations will propel revenue, particularly in developed markets. Expanded indications for prenatal and adolescent care will also contribute.

• Formulation Innovations:
  Depot injections and dissolvable films are anticipated to capture significant market share by improving adherence and safety.

Long-Term Outlook (2028–2033)

• Market Maturity and Consolidation:
  Biosimilar and generic entries will intensify competition, driving price reductions. However, continued innovation will sustain growth for premium formulations.

• Global Expansion:
  Emerging markets, notably Latin America and Southeast Asia, are expected to experience accelerated growth owing to increasing disease burden and favorable policies.

• Impact of Policy Changes:
  Regulatory shifts advocating for broader access, including telemedicine-enabled prescribing, will reshape the market landscape.

• Potential Disruptors:
  Advances in non-invasive brain stimulation therapies and novel pharmacological approaches could influence the demand dynamics.

Conclusion

Recent clinical trials affirm BUP/NAL’s position as the gold standard in OUD treatment, with ongoing studies promising further enhancements in delivery mechanisms and safety. The market is poised for steady growth driven by the global opioid crisis, evolving regulatory environments, and innovative formulations. Stakeholders should focus on expanding access, fostering innovation, and navigating regulatory pathways to capitalize on this expanding market.

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Key Takeaways

• Clinical Evidence Supports Efficacy:
  BUP/NAL remains highly effective in reducing opioid cravings, overdose risk, and misuse, validated through multiple recent clinical trials.

• Growing Market with Strong Demand:
  The global market is expanding at 6% CAGR, driven by rising opioid addiction rates and improved regulatory acceptance.

• Innovation Is Key to Future Growth:
  Long-acting depot formulations and novel delivery systems are expected to dominate future sales.

• Regional Opportunities Exist:
  North America leads, but emerging markets in Asia-Pacific and Latin America offer significant growth potential.

• Strategic Focus Areas:
  Companies should prioritize formulation innovation, expand access through policy advocacy, and navigate regulatory landscapes for sustained growth.

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FAQs

1. What are the main advantages of BUP/NAL over other opioid treatments?

BUP/NAL offers a favorable safety profile, lower diversion and misuse potential (due to Naloxone’s deterrent effect), and outpatient convenience, making it preferable over methadone and other treatments for many patients.

2. Are there any new formulations of BUP/NAL under clinical development?

Yes. Extended-release injections and dissolvable films are in advanced clinical stages, promising improved adherence and reduced diversion risk.

3. How has the COVID-19 pandemic influenced the BUP/NAL market?

The pandemic accelerated telemedicine adoption and regulatory relaxation, facilitating wider access to BUP/NAL, thus boosting consumption.

4. What regulatory challenges does BUP/NAL face globally?

Variability in prescribing regulations, scheduling classifications, and reimbursement policies can delay market entry and limit access, especially in emerging economies.

5. What future trends can be expected in the clinical research of BUP/NAL?

Focus areas include long-acting formulations, efficacy in special populations, and combination therapies addressing relapse prevention.

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Sources
[1] National Institute on Drug Abuse (NIDA). 2022. Efficacy of BUP/NAL in Opioid Use Disorder.
[2] The Lancet. 2022. Extended-Release Buprenorphine for Opioid Dependence.
[3] Journal of Addiction Medicine. 2021. Misuse Deterrence Measures in BUP/NAL.
[4] Obstetrics & Gynecology. 2022. BUP/NAL Use During Pregnancy.
[5] MarketsandMarkets. 2023. Opioid Dependence Treatment Market Analysis.
[6] CDC. 2022. Overdose Deaths in the United States.