CLINICAL TRIALS PROFILE FOR BUPRENORPHINE

505(b)(2) Clinical Trials for Buprenorphine

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.
New Dosage	NCT03608696 ↗	Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure	Completed	Chiesi Farmaceutici S.p.A.	Phase 1/Phase 2	2018-08-29	Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.
New Dosage	NCT03608696 ↗	Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure	Completed	Thomas Jefferson University	Phase 1/Phase 2	2018-08-29	Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.

All Clinical Trials for Buprenorphine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000200 ↗	Cocaine Effects in Humans: Physiology and Behavior - 1	Completed	Columbia University	Phase 2	1997-01-01	The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.
NCT00000200 ↗	Cocaine Effects in Humans: Physiology and Behavior - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1997-01-01	The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.
NCT00000202 ↗	Buprenorphine Maintenance for Opioid Addicts - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1988-08-01	The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in treatment of opiate and cocaine dependence.

Clinical Trial Conditions for Buprenorphine

Condition Name

Condition Name for Buprenorphine
Intervention	Trials
Opioid-Related Disorders	94
Opioid Use Disorder	46
Opioid-use Disorder	45

Condition MeSH

Condition MeSH for Buprenorphine
Intervention	Trials
Opioid-Related Disorders	275
Substance-Related Disorders	81
Disease	51

Clinical Trial Locations for Buprenorphine

Trials by Country

Trials by Country for Buprenorphine
Location	Trials
Japan	29
United Kingdom	28
Germany	12
Canada	12
Australia	8

Trials by US State

Trials by US State for Buprenorphine
Location	Trials
New York	92
California	74
Maryland	68
Pennsylvania	67
Florida	64

Clinical Trial Progress for Buprenorphine

Clinical Trial Phase

Clinical Trial Phase for Buprenorphine
Clinical Trial Phase	Trials
Phase 4	94
Phase 3	104
Phase 2/Phase 3	16

Clinical Trial Status

Clinical Trial Status for Buprenorphine
Clinical Trial Phase	Trials
Completed	303
Recruiting	66
Not yet recruiting	43

Clinical Trial Sponsors for Buprenorphine

Sponsor Name

Sponsor Name for Buprenorphine
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	166
Yale University	37
Indivior Inc.	30

Sponsor Type

Sponsor Type for Buprenorphine
Sponsor	Trials
Other	500
Industry	201
NIH	178

Buprenorphine: Clinical Trials, Market Analysis, and Projections

Introduction to Buprenorphine

Buprenorphine is a medication widely used in the treatment of opioid use disorder (OUD) and chronic pain. Its efficacy in managing withdrawal symptoms and cravings has made it a crucial component in addiction treatment. Here, we will delve into the current clinical trials, market analysis, and future projections for buprenorphine.

Clinical Trials Update

High Dose Buprenorphine Induction in Emergency Departments

A significant clinical trial currently underway involves the evaluation of high dose buprenorphine induction in emergency departments (EDs). This Phase 3 trial, conducted by Mount Sinai, compares the safety, tolerability, and feasibility of high dose buprenorphine induction (32 mg) against the standard dose (12 mg)[1].

• Trial Design: The study includes two cohorts: one receiving the standard 12 mg dose and another receiving the high dose of 32 mg. If the 32 mg dose is intolerable, a 24 mg dose may be evaluated.
• Objectives: The primary goal is to determine if high dose buprenorphine induction can increase the proportion of patients who engage in comprehensive addiction services within 7 days of induction.
• Collaboration: This research is conducted in collaboration with the National Institute on Drug Abuse (NIDA) and aims to achieve a minimum increase of 15% in engagement in comprehensive addiction treatment in the high dose induction group to justify larger future trials.

Injectable Long-Acting Buprenorphine Formulations

Another notable study is the Project COMMIT, which evaluates the use of an injectable long-acting monthly formulation of buprenorphine (LAB) in hospital settings. This study compares LAB initiated during hospitalization against standard addiction treatment for patients with OUD and related infections[4].

• Objective: The goal is to assess whether LAB can effectively initiate MOUD treatment within hospital settings and bridge to treatment after discharge.
• Significance: This approach has the potential to improve treatment outcomes by ensuring continuous care from hospitalization to post-discharge.

Market Analysis

Current Market Size and Growth

The global buprenorphine market is experiencing significant growth driven by several factors:

• Market Size: In 2023, the global buprenorphine market was valued at approximately $5.52 billion and is expected to grow at a CAGR of 14.9% during the forecast period[3].
• Forecast: By 2037, the market is projected to reach $35.75 billion, with a CAGR of around 14.4% between 2025 and 2037[2].

Growth Drivers

Several factors are driving the growth of the buprenorphine market:

• Increasing Opioid Addiction: The rising prevalence of opioid addiction globally is a major driver. As more people seek treatment, the demand for buprenorphine increases[5].
• Government Initiatives: Government investments in healthcare and initiatives to combat the opioid crisis are boosting the adoption of buprenorphine-based treatments[5].
• Diverse Formulations: The availability of buprenorphine in various formulations such as sublingual, transdermal, and buccal is enhancing its accessibility and effectiveness[2].
• Regulatory Approvals: Recent approvals by regulatory authorities, such as the FDA approval of Brixadi (buprenorphine) extended-release injection, are further driving market growth[3].

Market Segmentation

The buprenorphine market is segmented by route of administration, with the sublingual segment anticipated to hold the largest share due to its rapid drug absorption and quick onset of action. The buccal dosage segment is also expected to witness notable growth[2].

Market Projections

Future Growth and Trends

The future of the buprenorphine market looks promising, driven by several trends and factors:

• Expanding Applications: The growing use of buprenorphine patches and other formulations for chronic pain management, in addition to OUD treatment, is expected to drive market growth[2].
• Technological Advancements: Developing technologies and new delivery methods, such as injectable forms, are enhancing the drug's effectiveness and accessibility[5].
• Legislative Support: Government initiatives and regulatory approvals are expected to continue supporting the market's growth[3].

Key Players

Major players in the global buprenorphine market include:

• Mallinckrodt
• Noramco
• Unichem Laboratories Ltd.
• Sanofi
• Johnson Matthey
• Indivior PLC
• Titan Pharmaceuticals, Inc.
• Hikma Pharmaceuticals PLC[3].

Challenges and Restraints

Despite the positive outlook, the buprenorphine market faces some challenges:

• Regulatory Hurdles: Strict regulatory requirements and potential side effects can act as restraints to market growth[3].
• Competition: The presence of other opioid addiction treatments and generic versions of buprenorphine can pose competitive challenges[5].

Key Takeaways

• Clinical Trials: Ongoing clinical trials are evaluating the safety and efficacy of high dose buprenorphine induction and injectable long-acting formulations.
• Market Growth: The global buprenorphine market is expected to grow significantly, driven by increasing opioid addiction, government initiatives, and diverse formulations.
• Future Trends: Technological advancements, legislative support, and expanding applications will continue to drive market growth.

FAQs

What is the current focus of clinical trials involving buprenorphine?

The current clinical trials are focused on evaluating the safety and efficacy of high dose buprenorphine induction in emergency departments and the use of injectable long-acting buprenorphine formulations in hospital settings.

What are the key drivers of the buprenorphine market?

The key drivers include the increasing prevalence of opioid addiction, government initiatives to combat the opioid crisis, and the availability of diverse formulations such as sublingual, transdermal, and buccal.

What is the projected market size of buprenorphine by 2037?

The global buprenorphine market is projected to reach $35.75 billion by 2037, growing at a CAGR of around 14.4% between 2025 and 2037.

Which segment of the buprenorphine market is expected to hold the largest share?

The sublingual segment is anticipated to hold the largest share due to its rapid drug absorption and quick onset of action.

What are some of the challenges facing the buprenorphine market?

The market faces challenges such as regulatory hurdles, potential side effects, and competition from other opioid addiction treatments and generic versions of buprenorphine.

Sources

1. Mount Sinai: High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)[1].
2. Research Nester: Buprenorphine Market Size & Share, Growth Trends 2037[2].
3. Coherent Market Insights: Buprenorphine Market Size, Trends and Forecast to 2030[3].
4. Yale Program in Addiction Medicine: Current Studies[4].
5. GitHub: Buprenorphine Hydrochloride Sales Market Trends And Drivers[5].