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NCT00000326 ↗	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1997-04-01	The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone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.

Clinical Trial Conditions for Buprenorphine Hydrochloride; Naloxone Hydrochloride

Condition Name

Condition Name for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Intervention	Trials
Opioid-Related Disorders	30
Opioid Use Disorder	21
Opioid Dependence	20
Opioid-use Disorder	16

Condition MeSH

Condition MeSH for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Intervention	Trials
Opioid-Related Disorders	102
Substance-Related Disorders	24
Disease	15
Heroin Dependence	15

Clinical Trial Locations for Buprenorphine Hydrochloride; Naloxone Hydrochloride

Trials by Country

Trials by Country for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Location	Trials
United States	235
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	26
Maryland	24
California	19
Florida	12
Pennsylvania	12

Clinical Trial Progress for Buprenorphine Hydrochloride; Naloxone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Clinical Trial Phase	Trials
Phase 4	35
Phase 3	20
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Clinical Trial Phase	Trials
Completed	75
Recruiting	17
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)	45
Indivior Inc.	13
University of California, Los Angeles	9

Sponsor Type

Sponsor Type for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Sponsor	Trials
Other	139
Industry	49
NIH	47

Buprenorphine Hydrochloride and Naloxone Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Buprenorphine hydrochloride and naloxone hydrochloride are crucial components in the treatment of opioid use disorder (OUD). This article delves into the recent clinical trials, market analysis, and future projections for these medications.

Clinical Trials: Efficacy and Safety

Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations

A significant randomized clinical trial compared the efficacy of weekly and monthly subcutaneous buprenorphine depot formulations with daily sublingual buprenorphine-naloxone in treating OUD. Conducted at 35 outpatient sites in the United States from December 2015 to October 2016, this trial involved 428 participants with moderate-to-severe OUD.

• Outcomes: The trial demonstrated that the subcutaneous buprenorphine group had a higher proportion of opioid-negative urine samples (35.1% vs 28.4%) and a higher response rate (17.4% vs 14.4%) compared to the sublingual buprenorphine-naloxone group. Both primary outcomes showed noninferiority, indicating that long-acting buprenorphine depot formulations are efficacious for OUD treatment[1][4].

Extended-Release Injection vs Sublingual Buprenorphine

A post hoc analysis of a 24-week trial further supported the effectiveness of extended-release subcutaneous buprenorphine injections. This analysis, conducted from March 2022 to August 2023, compared urine-based opioid outcomes in participants receiving subcutaneous buprenorphine versus sublingual buprenorphine-naloxone, stratified by fentanyl use at baseline. The results suggested that extended-release injected formulations may provide an advantage, especially in patients with fentanyl use[4].

Market Analysis

Global Buprenorphine Hydrochloride Market

The global buprenorphine hydrochloride market is valued at USD 148.55 million in 2023 and is projected to reach USD 178.09 million by 2032, growing at a CAGR of 2.3% from 2024 to 2032. This market growth is driven by the increasing demand for effective treatments for OUD and the advantages of sustained-release formulations[2].

Opioid Use Disorder (OUD) Market

The global OUD market, which includes buprenorphine hydrochloride, is expected to grow from $3.62 billion in 2024 to $7.48 billion by 2032, at a CAGR of 9.5%. The buprenorphine segment dominates this market due to its widespread adoption in developed regions like the U.S. and France. Key products such as SUBLOCADE, SUBOXONE, and ZUBSOLV contribute significantly to this segment[3].

Suboxone Market

The global Suboxone market, which is a combination of buprenorphine and naloxone, is expected to exhibit a CAGR of 4.0% during the forecast period, driven by the increasing launches of generic Suboxone drugs. For instance, Alkem Labs received FDA approval for a generic version of Suboxone in June 2021, contributing to market growth[5].

Market Segments and Trends

By Application

Buprenorphine hydrochloride is used as an analgesic and opioid antagonist. The opioid antagonist application is particularly significant in the context of OUD treatment[2].

By Type

The market includes various forms of buprenorphine hydrochloride, such as tablets and injections. The injection segment, particularly the subcutaneous depot formulations, is gaining traction due to its convenience and efficacy[2].

Regional Analysis

North America dominates the OUD market, including the buprenorphine segment, due to high demand and governmental initiatives to combat the opioid epidemic. Other regions, such as Europe and Asia Pacific, are also expected to contribute to the market growth[3].

Key Players and Competitive Landscape

Major players in the buprenorphine hydrochloride market include Resonance-labs, Unichemlabs, Noramco, Siegfried, Faranshimi, Johnson Matthey, Rusan Pharma, Mallinckrodt, Sanofi, Sun Pharma, Mocind, Sinopharm, and Arevipharma. Companies like Indivior PLC, Alkermes, and Orexo AB are also significant in the global OUD market[2][3].

Future Projections

Increasing Demand for Sustained-Release Formulations

The market is expected to grow due to the increasing demand for effective and convenient treatments for OUD. Sustained-release formulations, such as weekly and monthly subcutaneous buprenorphine depot injections, are anticipated to play a crucial role in this growth[1][3].

Governmental Initiatives and Awareness

Governmental involvement in tackling the opioid epidemic and increasing awareness about OUD treatment options are expected to drive the adoption of buprenorphine hydrochloride and naloxone hydrochloride treatments[3].

New Product Launches

The launch of generic versions of buprenorphine and naloxone products, as well as new product developments by major players, will continue to drive market growth[5].

Key Takeaways

• Clinical Efficacy: Weekly and monthly subcutaneous buprenorphine depot formulations have been shown to be noninferior to daily sublingual buprenorphine-naloxone in treating OUD.
• Market Growth: The global buprenorphine hydrochloride market and the OUD market are expected to grow significantly, driven by increasing demand for effective treatments and governmental initiatives.
• Regional Dominance: North America currently dominates the market, but other regions are expected to contribute to future growth.
• Key Players: Major pharmaceutical companies are investing in buprenorphine hydrochloride and naloxone hydrochloride products, including sustained-release formulations.

FAQs

Q: What are the primary outcomes of the clinical trial comparing subcutaneous buprenorphine depot formulations with sublingual buprenorphine-naloxone?

A: The primary outcomes showed that the subcutaneous buprenorphine group had a higher proportion of opioid-negative urine samples and a higher response rate compared to the sublingual buprenorphine-naloxone group, demonstrating noninferiority[1].

Q: What is the projected growth rate of the global buprenorphine hydrochloride market from 2024 to 2032?

A: The global buprenorphine hydrochloride market is projected to grow at a CAGR of 2.3% from 2024 to 2032[2].

Q: Which segment dominates the Opioid Use Disorder (OUD) market?

A: The buprenorphine segment dominates the OUD market due to its widespread adoption in developed regions and the presence of several branded products[3].

Q: What is the expected market size of the global Suboxone market by 2030?

A: The global Suboxone market is expected to surpass US$ 8,410.7 million by 2030, growing at a CAGR of 4.0% during the forecast period[5].

Q: Which regions are expected to contribute significantly to the growth of the buprenorphine hydrochloride market?

A: North America currently dominates the market, but other regions such as Europe and Asia Pacific are also expected to contribute to future growth[3].

Sources

1. Lofwall MR, Walsh SL, Nunes EV, et al. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018;178(6):764–773. doi:10.1001/jamainternmed.2018.1052
2. Vantage Market Research. Buprenorphine Hydrochloride Market: Trends & Size 2032.
3. Fortune Business Insights. Opioid Use Disorder [OUD] Market Size, Share | Growth, 2032.
4. JAMA Network Open. Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder.
5. GlobeNewswire. Global Suboxone Market to Surpass US$ 8,410.7 Million by 2030, Says Coherent Market Insights (CMI).