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Last Updated: April 30, 2025

CLINICAL TRIALS PROFILE FOR BREVIBLOC


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All Clinical Trials for Brevibloc

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01114971 ↗ Labetalol and Esmolol: Vital Signs and Post Operative Pain Management Completed Cedars-Sinai Medical Center Phase 4 2009-09-03 This study proposes to investigate the effects of labetalol or esmolol on managing the vital signs (like blood pressure and heart rate) during surgery, on pain management, and on the later recovery after surgery. It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.
NCT01179113 ↗ Esmolol Infusion During Laminectomy: Effect on Quality of Recovery Terminated Cedars-Sinai Medical Center Phase 4 2011-06-01 The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly administered during surgery to help control blood pressure and heart rate, on postoperative pain levels and requirements for pain medication.
NCT01208402 ↗ Esmolol for Treatment of Perioperative Tachycardia Terminated Baxter Healthcare Corporation Phase 3 2010-09-01 The purpose of this study is to find out if Esmolol is a safe and effective alternative treatment compared to standard treatment using a long acting beta blocker drug, in controlling abnormal heart rate before, during and immediately after surgery.
NCT01208402 ↗ Esmolol for Treatment of Perioperative Tachycardia Terminated Duke University Phase 3 2010-09-01 The purpose of this study is to find out if Esmolol is a safe and effective alternative treatment compared to standard treatment using a long acting beta blocker drug, in controlling abnormal heart rate before, during and immediately after surgery.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Brevibloc

Condition Name

Condition Name for Brevibloc
Intervention Trials
Septic Shock 3
Hemorrhagic Stroke 1
Subarachnoid Hemorrhage 1
High-risk, Non-cardiovascular Surgeries 1
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Condition MeSH

Condition MeSH for Brevibloc
Intervention Trials
Shock, Septic 3
Shock 3
Tachycardia 2
Hernia 1
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Clinical Trial Locations for Brevibloc

Trials by Country

Trials by Country for Brevibloc
Location Trials
United States 8
Brazil 6
Turkey 3
China 1
Egypt 1
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Trials by US State

Trials by US State for Brevibloc
Location Trials
Utah 2
California 2
Maryland 1
Michigan 1
Ohio 1
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Clinical Trial Progress for Brevibloc

Clinical Trial Phase

Clinical Trial Phase for Brevibloc
Clinical Trial Phase Trials
Phase 4 7
Phase 3 1
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Brevibloc
Clinical Trial Phase Trials
Completed 7
Unknown status 3
Withdrawn 3
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Clinical Trial Sponsors for Brevibloc

Sponsor Name

Sponsor Name for Brevibloc
Sponsor Trials
Cedars-Sinai Medical Center 2
Baxter Healthcare Corporation 2
Beth Israel Deaconess Medical Center 2
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Sponsor Type

Sponsor Type for Brevibloc
Sponsor Trials
Other 19
Industry 4
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BREVIBLOC (Esmolol Hydrochloride): Clinical Trials, Market Analysis, and Projections

Introduction

BREVIBLOC, or esmolol hydrochloride, is a cardioselective beta blocker widely used for the short-term management of various cardiac conditions. This article will delve into recent clinical trials, market analysis, and projections for this drug.

Clinical Indications and Usage

BREVIBLOC is indicated for the rapid control of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter, as well as noncompensatory sinus tachycardia. It is also used for the short-term treatment of perioperative tachycardia and hypertension[1].

Clinical Trials Update

Supraventricular Tachycardia and Noncompensatory Sinus Tachycardia

Clinical trials have shown that BREVIBLOC is effective in controlling ventricular rate in patients with supraventricular tachycardia and noncompensatory sinus tachycardia. The drug is administered intravenously, often with a loading dose followed by a continuous infusion, which allows for rapid titration to achieve the desired heart rate[1].

Adverse Reactions

In clinical trials, the most common adverse reactions to BREVIBLOC include hypotension, which resolved in 63% of patients during the infusion and in 80% of the remaining patients within 30 minutes after discontinuation. Other common adverse effects include infusion site reactions, nausea, dizziness, and somnolence[1].

Novel Uses: Topical Esmolol

A recent phase 3 clinical trial explored the use of topical esmolol hydrochloride for treating diabetic foot ulcers. The study, conducted across 27 tertiary care centers in India, indicated that topical esmolol may be an effective addition to standard care for wound closure. The trial showed promising results in terms of ulcer closure rates and safety profile[5].

Market Analysis

Market Status and Availability

BREVIBLOC is currently marketed by Baxter Corporation and is available in various formulations, including a premixed injection. However, there have been reports of disruptions in manufacturing, leading to potential shortages[2].

Pricing and Cost

The cost of BREVIBLOC can vary significantly depending on the pharmacy and the specific formulation. For instance, a 250 mL supply of the 10 mg/mL intravenous solution can cost around $571 for cash-paying customers. Generic versions of esmolol are also available, which can be more affordable, starting from $83.88 for 100 milliliters[3].

Market Trends

The market for cardioselective beta blockers, including BREVIBLOC, is influenced by the demand for effective and safe treatments for cardiac conditions. The refractory angina treatment market, for example, is expected to grow, with new drugs entering clinical trials. However, BREVIBLOC's niche in short-term cardiac management remains stable due to its rapid onset and short duration of action[4].

Market Projections

Demand and Growth

The demand for BREVIBLOC is expected to remain steady due to its established role in managing acute cardiac conditions. The growing need for effective perioperative and postoperative cardiac management will continue to drive the market for this drug.

Competitive Landscape

While BREVIBLOC faces competition from other beta blockers, its unique pharmacokinetic profile, which allows for rapid titration and short duration of action, maintains its position in the market. The availability of generic versions may impact the market share of the branded product but is unlikely to significantly alter the overall demand for esmolol hydrochloride.

Challenges and Opportunities

One of the challenges facing BREVIBLOC is the potential for manufacturing disruptions, which can lead to shortages. However, this also presents an opportunity for other manufacturers to enter the market with generic or alternative formulations. The exploration of novel uses, such as topical applications, could further expand the market for esmolol hydrochloride.

Key Takeaways

  • Clinical Indications: BREVIBLOC is used for the short-term management of supraventricular tachycardia, noncompensatory sinus tachycardia, and perioperative tachycardia and hypertension.
  • Clinical Trials: Recent trials have reaffirmed its efficacy and safety profile, with novel uses being explored, such as topical application for diabetic foot ulcers.
  • Market Analysis: The drug is marketed by Baxter Corporation, with pricing varying by formulation and pharmacy. Generic versions are available and can be more affordable.
  • Market Projections: Steady demand is expected due to its established role in cardiac management, despite potential competition and manufacturing challenges.

FAQs

What are the primary indications for BREVIBLOC?

BREVIBLOC is indicated for the rapid control of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter, as well as noncompensatory sinus tachycardia. It is also used for the short-term treatment of perioperative tachycardia and hypertension[1].

What are the common adverse reactions to BREVIBLOC?

Common adverse reactions include hypotension, infusion site reactions, nausea, dizziness, and somnolence[1].

Is BREVIBLOC available in generic form?

Yes, generic versions of esmolol hydrochloride are available and can be more affordable than the branded product[3].

What is the current market status of BREVIBLOC?

BREVIBLOC is currently marketed by Baxter Corporation, but there have been reports of manufacturing disruptions leading to potential shortages[2].

Are there any novel uses being explored for BREVIBLOC?

Yes, recent clinical trials have explored the use of topical esmolol hydrochloride for treating diabetic foot ulcers, showing promising results[5].

How does the pricing of BREVIBLOC vary?

The cost of BREVIBLOC can vary significantly depending on the pharmacy and the specific formulation. For example, a 250 mL supply of the 10 mg/mL intravenous solution can cost around $571 for cash-paying customers[3].

Sources

  1. BREVIBLOC injection - accessdata.fda.gov
  2. Drug Shortage Report for BREVIBLOC PREMIXED INJECTION - drugshortagescanada.ca
  3. Brevibloc Prices, Coupons, Copay Cards & Patient Assistance - drugs.com
  4. Refractory Angina Treatment Market - Trends, Size, Share - coherentmi.com
  5. Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers - jamanetwork.com

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