CLINICAL TRIALS PROFILE FOR BRIDION

All Clinical Trials for Bridion

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00751179 ↗	Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2008-11-01	A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.
NCT00953550 ↗	Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine	Completed	TrygFonden, Denmark	Phase 4	2009-09-01	Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol. Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.
NCT00953550 ↗	Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine	Completed	Rigshospitalet, Denmark	Phase 4	2009-09-01	Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol. Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.
NCT01213264 ↗	Observational Study to Evaluate the Current Neuromuscular Monitoring Practice Used After Different Types of Surgery, for Which Neuromuscular Blocking Agents Were Used, With or Without Blocking Reversal (P06556)	Completed	Merck Sharp & Dohme Corp.		2010-09-01	The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries). Secondarily the study will observe, for which surgical procedures neuromuscular blocking agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all drugs used during anesthesia) will be done in accordance with routine anesthesiology practice, and labeling guidelines. Neuromuscular transmission will be monitored according to routine anesthesiology practice by means of acceleromyography. The assignment of the participant to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.
NCT01424488 ↗	Sugammadex Efficacy and Safety for Reversal of Pipecuronium-induced Neuromuscular Blockade	Unknown status	Central Clinical Hospital #1 of LLC Russian Railways	Phase 4	2011-09-01	Primary objectives: 1. to investigate the efficacy of sugammadex in dose of 4 mg/kg administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade in subjects undergoing abdominal surgery under general anesthesia 2. to evaluate the safety and tolerability of a single dose of 4 mg/kg sugammadex administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade Secondary objectives: 1. to evaluate the time from the start of sugammadex or placebo administration to the time of extubation and to the time of recovery of TOF ratio to ≥ 0.9 Exploratory objectives: 1. to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay after the end of surgery in subjects with pipecuronium induced neuromuscular blockade reversed by 4.0 mg.kg-1 sugammadex compared to placebo (saline) 2. compare the number of patients extubated in the OR after the reversal by sugammadex or placebo, evaluate the TOF ratio at the time of extubation Clinical hypothesis: 1. Sugammadex has to be effective and well tolerated for reversal of pipecuronium-induced blockade
NCT01453530 ↗	Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade	Unknown status	Radboud University	Phase 4	2011-10-01	Rationale: Recovery from outpatient anesthesia includes dissipation of anesthetics agents, normalization of physiological function, observation for medical or surgical complications, treatment of immediate side effects of anesthesia and surgery and, ultimately, discharge and return home. Street fitness implies that the patient is not only ready to go home, but is also capable of safely taking part in the traffic. A full recovery of cognitive functions is part of this stage. Neuromuscular blocking agents (NMBAs) are commonly used during surgery to facilitate endotracheal intubation, allow assisted or controlled ventilation, and let surgery proceed easily. Sugammadex is approved in Europe for routine clinical use to reverse neuromuscular blockade induced by steroidal non-depolarizing muscle relaxants. Several anesthesiologists from all over the world, have independently reported that patients seem to be more alert in the early phase of recovery after reversal of NMB with sugammadex compared to reversal with a cholinesterase inhibitor or spontaneous recovery. However, these observations have not been substantiated in a clinical study. Objective: The main aim of the present study is to assess whether sugammadex has a positive effect on the post-operative alertness of the patients, to assess the nature, magnitude and the time of onset of this effect and if a clinically relevant effect has been observed to enable the sample size calculation for a formal well-powered efficacy study. Study design: Randomized, controlled observer-blind single centre phase IV study. Upon After stratification for type of surgery and age patients will be randomized to receive sugammadex (arm A), neostigmine/glycopyrrolate (Arm B) or no reversal agent (arm C). Study population: A total of 30 evaluable subjects, aged 18-65 years, with a medical need for general anesthesia and neuromuscular blockade, will be included in the study. Intervention: Anesthesia will be standardized according to the usual protocol. At the end of the surgery when TOF ratio is ~0,9, and approximately 70-80% of nicotine receptors are still blocked by rocuronium, patients will receive either sugammadex, neostigmine plus glycopyrrolate, or no reversal agent. Main study parameters: At 30, 60, and 120 minutes after the TOF ratio of ~0,9 has been reached, the following commonly used, and non-invasive cognitive evaluations/scoring lists will be carried out in a subsequent order to assess recovery and psychomotor function: Modified Aldrete Score, the trail making test, the Maddox wing test, and visual analogue scales from both observer and patient.

Clinical Trial Conditions for Bridion

Condition Name

Condition Name for Bridion
Intervention	Trials
Neuromuscular Blockade	17
Postoperative Complications	3
Pharmacokinetics	3
Reversal of Neuromuscular Blockade	2

Condition MeSH

Condition MeSH for Bridion
Intervention	Trials
Delayed Emergence from Anesthesia	5
Postoperative Complications	4
Nausea	2
Pain, Postoperative	2

Clinical Trial Locations for Bridion

Trials by Country

Trials by Country for Bridion
Location	Trials
United States	28
China	7
Netherlands	5
Belgium	4
Korea, Republic of	4

Trials by US State

Trials by US State for Bridion
Location	Trials
Pennsylvania	3
Florida	3
California	2
Missouri	2
New York	2

Clinical Trial Progress for Bridion

Clinical Trial Phase

Clinical Trial Phase for Bridion
Clinical Trial Phase	Trials
Phase 4	40
Phase 3	5
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Bridion
Clinical Trial Phase	Trials
Completed	37
Unknown status	11
Recruiting	7

Clinical Trial Sponsors for Bridion

Sponsor Name

Sponsor Name for Bridion
Sponsor	Trials
Merck Sharp & Dohme Corp.	15
Guangzhou General Hospital of Guangzhou Military Command	4
Seoul National University Bundang Hospital	3

Sponsor Type

Sponsor Type for Bridion
Sponsor	Trials
Other	79
Industry	22

BRIDION: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to BRIDION

BRIDION, also known as sugammadex, is a revolutionary drug approved by the US Food and Drug Administration (FDA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults and children undergoing surgery. This article delves into the clinical trials, market analysis, and future projections of BRIDION.

Clinical Trials and Efficacy

FDA Approval and Clinical Studies

BRIDION was approved based on the results of three Phase 3 clinical trials involving 456 participants. These trials demonstrated that BRIDION significantly reduced the recovery time from neuromuscular blockade compared to traditional reversal agents. Most participants recovered within 5 minutes of BRIDION administration, highlighting its rapid efficacy[1].

Special Patient Populations

BRIDION has been studied in various special patient populations, including geriatric, cardiac, and pulmonary patients. In geriatric patients, BRIDION showed comparable recovery times to other treatment groups, indicating its safety and efficacy in this demographic[4].

For cardiac patients, particularly those with ischemic disease, chronic heart failure, or arrhythmia, BRIDION demonstrated safe and effective reversal of neuromuscular blockade without significant adverse effects[4].

In pulmonary patients with moderate block, BRIDION achieved rapid reversal, with the time from administration to a train-of-four (TOF) ratio of 0.9 being a key efficacy endpoint. These studies underscore BRIDION's versatility and safety across diverse patient groups[4].

Dosage and Administration

Recommended Dosing

The recommended dose of BRIDION depends on the level of neuromuscular blockade. For patients with 1 to 2 post-tetanic counts (PTC) and no twitch responses to train-of-four (TOF) stimulation, a dose of 4 mg/kg is recommended. For patients with spontaneous recovery to the reappearance of T2, a dose of 2 mg/kg is suggested[3].

Safety Considerations

BRIDION has been associated with increases in coagulation parameters such as activated partial thromboplastin time (aPTT) and prothrombin time/international normalized ratio (PT(INR)), particularly in patients undergoing major orthopedic surgery and receiving heparin or low molecular weight heparin. However, these increases did not result in significant clinical bleeding or anemia[3].

Market Analysis

Sales Performance

BRIDION has shown mixed sales performance in recent years. In the full year of 2023, BRIDION sales were $1.842 billion, representing a 9% increase over the previous year. However, in certain ex-U.S. markets, particularly in Europe, BRIDION faced a decline due to generic competition, which was partially offset by higher demand in the U.S.[2].

Market Trends

The pharmaceutical market, especially the segment related to hospital acute care, has seen significant growth. BRIDION benefits from this trend as it is a critical component in surgical procedures. Despite competition from generics, BRIDION's unique mechanism of action and rapid reversal capabilities maintain its market relevance[2].

Projections and Future Outlook

Market Projections

Given the ongoing demand for efficient and safe neuromuscular blockade reversal agents, BRIDION is expected to continue playing a significant role in the market. While generic competition may impact sales in some regions, the drug's performance in the U.S. and other markets where it remains a preferred choice is likely to sustain its overall market presence[2].

Regulatory and Patent Considerations

The value of BRIDION is also influenced by regulatory and patent factors. GlobalData's NPV models take into account these factors, including patent law and regulatory approval processes, to evaluate the drug's future value. As the patent landscape evolves, BRIDION's market position will be closely monitored[5].

Key Takeaways

• Rapid Efficacy: BRIDION significantly reduces recovery time from neuromuscular blockade, with most patients recovering within 5 minutes.
• Broad Applicability: Effective in various patient populations, including geriatric, cardiac, and pulmonary patients.
• Safety Profile: Generally safe, with manageable increases in coagulation parameters in certain clinical contexts.
• Market Performance: Mixed sales performance due to generic competition, but sustained demand in key markets.
• Future Outlook: Expected to remain a critical component in surgical care despite competitive pressures.

FAQs

What is BRIDION used for?

BRIDION is used to reverse the effects of neuromuscular blockade induced by rocuronium or vecuronium in adults and children undergoing surgery.

How quickly does BRIDION work?

Most patients recover within 5 minutes of BRIDION administration.

Is BRIDION safe for special patient populations?

Yes, BRIDION has been shown to be safe and effective in geriatric, cardiac, and pulmonary patients.

What are the recommended doses of BRIDION?

The recommended doses are 4 mg/kg for patients with 1 to 2 post-tetanic counts and no twitch responses to TOF stimulation, and 2 mg/kg for patients with spontaneous recovery to the reappearance of T2.

How has BRIDION performed in the market?

BRIDION has seen a 9% increase in sales in 2023, though it faces competition from generics in some markets.

Sources

1. FDA Approves Bridion to Reverse Effects of Neuromuscular Blocking Drugs Used During Surgery. JHOP Online.
2. Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results. Merck.
3. BRIDION® (sugammadex) Injection. FDA.
4. Recovery in special patient populations - Merck Connect. Merck Connect.
5. Net Present Value Model: Bridion. GlobalData.

Last updated: 2025-01-01