CLINICAL TRIALS PROFILE FOR BRIXADI

All Clinical Trials for BRIXADI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04454411 ↗	Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder	Not yet recruiting	University of Pennsylvania	Phase 2	2021-08-02	This study will investigate the mechanisms of cognitive-behavioral response to medications used for relapse prevention in opioid use disorder (opioid addiction, OUD), through investigation of the neural circuits underlying key cognition functions. The study will use previously validated cognitive probes, functional Magnetic Resonance Imaging (fMRI), and novel extended-release injectable preparations of opioid partial agonist buprenorphine and antagonist naltrexone, in OUD patients to explain the individual heterogeneity of OUD treatment response.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Columbia University	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Columbia University Irving Medical Center	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Harvard Medical School	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Harvard Medical School (HMS and HSDM)	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Mclean Hospital	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.

Clinical Trial Conditions for BRIXADI

Condition Name

Condition Name for BRIXADI
Intervention	Trials
Opioid Dependence	1
Opioid Use Disorder	1
Opioid Use Disorder (OUD)	1

Condition MeSH

Condition MeSH for BRIXADI
Intervention	Trials
Opioid-Related Disorders	3
Substance-Related Disorders	2

Clinical Trial Locations for BRIXADI

Trials by Country

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−

Trials by Country for BRIXADI
Location	Trials
United States	16

Trials by US State

+

−

Trials by US State for BRIXADI
Location	Trials
Pennsylvania	2
West Virginia	1
Utah	1
South Carolina	1
Oregon	1

Clinical Trial Progress for BRIXADI

Clinical Trial Phase

Clinical Trial Phase for BRIXADI
Clinical Trial Phase	Trials
Phase 2	3

Clinical Trial Status

Clinical Trial Status for BRIXADI
Clinical Trial Phase	Trials
Not yet recruiting	2
Recruiting	1

Clinical Trial Sponsors for BRIXADI

Sponsor Name

Sponsor Name for BRIXADI
Sponsor	Trials
University of Pennsylvania	2
Columbia University	1
Columbia University Irving Medical Center	1

Sponsor Type

Sponsor Type for BRIXADI
Sponsor	Trials
Other	10
NIH	1
Industry	1

BRIXADI: A Revolutionary Treatment for Opioid Use Disorder

Introduction to BRIXADI

BRIXADI, developed by Braeburn Pharmaceuticals and licensed from Camurus, is a groundbreaking medication for the treatment of moderate to severe opioid use disorder (OUD). It is the first and only long-acting buprenorphine injectable available in both weekly and monthly doses, utilizing the innovative FluidCrystal® Injection Depot Technology.

Clinical Trials and Efficacy

Phase 3 Clinical Trials

BRIXADI has undergone rigorous clinical testing, including a 24-week Phase 3 double-blind study that randomized 428 adults with moderate to severe OUD. This study enrolled a diverse population, including patients who injected opioids, primarily used heroin, had evidence of fentanyl use, and used nonopioid substances at screening[1].

The trial demonstrated that BRIXADI met the primary endpoint of non-inferiority for responder rate compared to daily sublingual buprenorphine/naloxone (SL BPN/NX), with a responder rate of 16.9% for BRIXADI versus 14.0% for SL BPN/NX (p < 0.001). Additionally, BRIXADI showed superiority to SL BPN/NX based on the cumulative distribution function (CDF) of the percentage of negative opioid assessments from week 4 through week 24 (p = 0.004)[1].

Safety Profile

The safety of BRIXADI was evaluated in two Phase 3 clinical studies involving 440 opioid-dependent patients. These studies included one double-blind, active-control study and one open-label study. The results showed that adverse reactions led to premature discontinuation in 4.7% of patients receiving BRIXADI, compared to 2.3% in the sublingual buprenorphine/naloxone group. Common adverse reactions included those typical of buprenorphine treatment, such as injection site reactions and constipation[4].

Pharmacokinetics and Pharmacodynamics

In PK/PD trials, BRIXADI demonstrated a half-life sufficient to maintain adequate plasma levels throughout the dosing interval, reduced withdrawal symptoms, and successfully reduced the need for rescue buprenorphine doses. It also blocked the "liking" of hydromorphone challenge, indicating its efficacy in blocking opioid effects[3].

Market Analysis and Projections

Current Market and Launch

BRIXADI was approved by the FDA in May 2023 and became available in the U.S. in September 2023. The launch has been significant, with the product now available in all 50 U.S. states, often with unrestricted access through Medicaid and increasingly through private payers. The product is distributed through a restricted program called the BRIXADI REMS Program and is administered only by healthcare providers[2].

Financial Performance and Revenue

The launch of BRIXADI has contributed to strong financial performance for Camurus, Braeburn's licensing partner. Camurus received a one-time payment of USD 35 million from Braeburn for the U.S. approval of BRIXADI and reported the first royalty revenue for the product. This has led to a significant increase in Camurus' revenues and operating results, with total revenues amounting to SEK 1,342 million, an increase of 95% compared to the previous year[2].

Global Buprenorphine Market

The global buprenorphine market, in which BRIXADI is a key player, is estimated to be valued at US$ 5.52 billion in 2023. This market is expected to exhibit a Compound Annual Growth Rate (CAGR) of 14.9% during the forecast period from 2023 to 2030, reaching a projected value of US$ 14.64 billion by 2030. This growth is driven by increasing demand for effective treatments for opioid use disorder and the expanding use of buprenorphine-based medications[5].

Advantages and Unique Features

Dosing Flexibility

BRIXADI offers the unique advantage of both weekly and monthly dosing options, allowing for individualized treatment plans that align with current treatment guidelines. This flexibility is particularly beneficial for patients who may have varying needs and preferences[1][2].

Administration and Convenience

The medication is administered subcutaneously by healthcare providers, which can reduce the risk of diversion and misuse. BRIXADI also features smaller needle and dose volumes and multiple injection sites, enhancing patient comfort and convenience[2].

Integration into Treatment Plans

BRIXADI can be initiated on the first day of treatment after a test dose of oral buprenorphine, making it a seamless addition to existing treatment protocols. It is recommended to be used as part of a complete treatment plan that includes counseling and psychosocial support[1].

Key Takeaways

• Clinical Efficacy: BRIXADI has demonstrated non-inferiority and superiority to sublingual buprenorphine/naloxone in clinical trials.
• Safety Profile: The medication has a manageable safety profile with adverse reactions typical of buprenorphine treatment.
• Market Impact: BRIXADI's launch has contributed significantly to the financial performance of Camurus and is expected to grow the global buprenorphine market.
• Unique Features: Offers both weekly and monthly dosing, smaller needle and dose volumes, and can be initiated on the first day of treatment.
• Administration: Administered only by healthcare providers in a healthcare setting through the BRIXADI REMS Program.

FAQs

Q: What is BRIXADI and how is it administered?

BRIXADI is a long-acting buprenorphine injectable for the treatment of moderate to severe opioid use disorder. It is administered subcutaneously by healthcare providers in a healthcare setting.

Q: What are the dosing options available for BRIXADI?

BRIXADI is available in both weekly and monthly doses, allowing for individualized treatment plans.

Q: How does BRIXADI compare to other buprenorphine treatments?

BRIXADI has been shown to be non-inferior and superior to sublingual buprenorphine/naloxone in clinical trials and offers the unique advantage of both weekly and monthly dosing options.

Q: What are the common adverse reactions associated with BRIXADI?

Common adverse reactions include injection site reactions, constipation, and other typical buprenorphine-related side effects.

Q: Is BRIXADI available in all U.S. states?

Yes, BRIXADI is available in all 50 U.S. states, often with unrestricted access through Medicaid and increasingly through private payers.

Sources

1. Braeburn Pharmaceuticals. Braeburn’s BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder. [Press Release]. May 23, 2023.
2. Camurus. Strong financial performance and launch of Brixadi™ in the US. [Interim Report]. November 9, 2023.
3. VA.gov. Buprenorphine Subcutaneous Injection SA (BRIXADI)* Mini Monograph. [PDF]. September 2023.
4. Brixadihcp.com. Clinical Safety | BRIXADI® (buprenorphine) extended-release injection.
5. Coherent Market Insights. Buprenorphine Market Size, Trends and Forecast to 2030. [Report]. 2023.