CLINICAL TRIALS PROFILE FOR BYFAVO

All Clinical Trials for Byfavo

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05201300 ↗	Remimazolam and Propofol Anesthesia in Elderly Patients	Not yet recruiting	Ajou University School of Medicine	N/A	2022-02-01	Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability. A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results. The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.
NCT05412914 ↗	Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery	Not yet recruiting	Konkuk University Medical Center	Phase 4	2022-08-01	This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery. LV-GLS is analyzed by using speckle tracking technique of transthoracic echocardiography.
NCT05835713 ↗	Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam	Not yet recruiting	Samsung Medical Center	N/A	2023-05-01	Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Remimazolam, a recently developed anesthetics, showed faster recovery from anesthesia and stable hemodynamics compared to propofol, the most popular anesthetics. However, few studies have investigated the usefulness of remimazolam for rigid bronchoscopy. Therefore, the investigators compared the usefulness of propofol and remimazolam in total intravenous anesthesia for rigid bronchoscopy.
NCT05866315 ↗	The Effect of Remimazolam on Opioid Induced Hyperalgesia	Recruiting	Wonkwang University Hospital	N/A	2023-05-19	The goal of this prospective, randomized, controlled study is to investigate the effect of remimazolam on opioid-induced hyperalgesia (OIH) in patients undergoing single port-laparoscopically assisted urologic surgery. The main question[s] it aims to answer are: - [The mechanical hyperalgesia threshold] - [Area of hyperalgesia around the surgical incision 24 h after surgery (cm^2)] In three groups: Group RHR (Remimazolam- High-dose Remifentanil), Group DHR (Desflurane-low-dose Remifentanil) or Group DLR (Control).
NCT05907525 ↗	Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation	Recruiting	Pusan National University Yangsan Hospital	N/A	2023-06-29	The goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.

Clinical Trial Conditions for Byfavo

Condition Name

Condition Name for Byfavo
Intervention	Trials
Endobronchial Mass	1
Hemodynamics	1
Hyperalgesia, Mechanical	1
One-Lung Ventilation	1

Condition MeSH

Condition MeSH for Byfavo
Intervention	Trials
Respiration Disorders	1
Cataract	1
Hyperalgesia	1
Tracheal Stenosis	1

Clinical Trial Locations for Byfavo

Trials by Country

Trials by Country for Byfavo
Location	Trials
Korea, Republic of	4
United States	1

Trials by US State

Trials by US State for Byfavo
Location	Trials
California	1

Clinical Trial Progress for Byfavo

Clinical Trial Phase

Clinical Trial Phase for Byfavo
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Byfavo
Clinical Trial Phase	Trials
Not yet recruiting	5
Recruiting	3

Clinical Trial Sponsors for Byfavo

Sponsor Name

Sponsor Name for Byfavo
Sponsor	Trials
Ajou University School of Medicine	1
Konkuk University Medical Center	1
Samsung Medical Center	1

Sponsor Type

Sponsor Type for Byfavo
Sponsor	Trials
Other	8

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

Introduction to BYFAVO

BYFAVO, also known as remimazolam, is a benzodiazepine approved by the U.S. Food and Drug Administration (FDA) for the induction and maintenance of procedural sedation in adult patients undergoing procedures lasting 30 minutes or less. Here, we delve into the clinical trials, market performance, and future projections of this innovative drug.

Clinical Trials Overview

The approval of BYFAVO was based on three pivotal clinical trials that evaluated its efficacy and safety in various procedural settings.

Trial 1: Colonoscopy

In the first trial, BYFAVO demonstrated a high sedation success rate during colonoscopies. The results showed that 91.3% of patients who received BYFAVO achieved successful sedation, compared to only 1.7% in the placebo group[1].

Trial 2: Bronchoscopy

The second trial focused on bronchoscopy procedures and revealed that 80.6% of patients treated with BYFAVO achieved the primary endpoint of successful sedation, whereas only 4.8% of the placebo group did so[1].

Trial 3: Colonoscopy

The third trial, also involving colonoscopy, showed that 84.4% of patients receiving BYFAVO achieved successful sedation, in contrast to 15.6% in the placebo group[1].

Efficacy and Safety Profile

Procedural Sedation Success

BYFAVO has consistently demonstrated high procedural sedation success rates across various procedures, including colonoscopies and bronchoscopies. The drug's efficacy is defined by the completion of the procedure without the need for rescue medication and with no more than 5 top-up doses within any 15-minute window[4].

Rapid Onset and Offset

One of the key benefits of BYFAVO is its rapid onset and offset of action. The median time to peak sedation is 3.0-3.5 minutes, and the median time to being fully alert after the last dose is 11.0-14.0 minutes. This quick recovery time is particularly advantageous in clinical settings[4].

Safety Profile

The safety profile of BYFAVO is comparable to that of midazolam, with similar incidence rates of cardio-respiratory and other adverse reactions. The drug is designed to maintain a predictable level of sedation, reducing the risk of over-sedation and associated complications[3].

Market Analysis

Commercial Performance

Since its approval, BYFAVO has shown promising commercial performance. Eagle Pharmaceuticals, which acquired the rights to commercialize BYFAVO in the U.S., reported that sales of BYFAVO, along with another product Barhemsys, exceeded $1 million in the first quarter of 2023 and continued to grow in the second quarter. The company expects strong year-over-year and sequential growth for these products throughout 2023[2].

Market Share and Growth

BYFAVO is part of Eagle Pharmaceuticals' growing portfolio of hospital products. The company's well-trained sales force has been instrumental in driving the uptake of BYFAVO in hospitals. As of the second quarter of 2023, BYFAVO and Barhemsys were reflecting the anticipated growth pace, indicating a strong market reception[2].

Financial Projections

Revenue and Royalties

PAION AG, the developer of BYFAVO, is entitled to tiered royalties on net sales in the U.S., ranging from 20% to 25%, which can be adjusted under certain conditions but cannot fall below 15% of net sales. This royalty structure suggests a significant potential for revenue generation as BYFAVO's market presence expands[3].

Net Present Value (NPV) Model

GlobalData's NPV model for BYFAVO takes into account various factors including patent law, regulatory approvals, cash flows, and potential success rates. This model helps in evaluating the drug's value and predicting its future financial performance. While the exact NPV figures are not publicly disclosed, the model indicates a positive outlook for BYFAVO's financial prospects[5].

Key Takeaways

• High Efficacy: BYFAVO has demonstrated high sedation success rates in clinical trials across different procedures.
• Rapid Onset and Offset: The drug offers quick onset and recovery times, making it ideal for short procedures.
• Safety Profile: BYFAVO's safety profile is comparable to midazolam, with a predictable level of sedation.
• Market Growth: The drug has shown strong commercial performance and is expected to continue growing in the market.
• Financial Projections: BYFAVO is projected to generate significant revenue through sales and royalties.

FAQs

What is BYFAVO used for?

BYFAVO is used for the induction and maintenance of procedural sedation in adult patients undergoing procedures lasting 30 minutes or less.

How effective is BYFAVO in clinical trials?

BYFAVO has shown high efficacy in clinical trials, with success rates ranging from 80.6% to 91.3% across different procedures, significantly outperforming the placebo groups[1][4].

What are the key benefits of BYFAVO?

The key benefits include rapid onset and offset of action, a predictable level of sedation, and a safety profile comparable to midazolam[3][4].

Who commercializes BYFAVO in the U.S.?

BYFAVO is commercialized in the U.S. by Eagle Pharmaceuticals, which acquired the rights from Acacia Pharma[2].

What are the financial projections for BYFAVO?

BYFAVO is expected to generate significant revenue through sales and royalties, with a positive outlook based on GlobalData's NPV model[5].

Sources

1. FDA: Drug Trials Snapshots: BYFAVO - FDA
2. Biospace: Eagle Pharmaceuticals Provides Business Update and Reiterates 2023 Guidance
3. PAION: PAION announces US FDA approval of remimazolam (BYFAVO TM) for the induction and maintenance of procedural sedation
4. Byfavo: Procedural sedation for a broad range of patients - Byfavo
5. GlobalData: Net Present Value Model: Byfavo - GlobalData