CLINICAL TRIALS PROFILE FOR VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

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
OTC	NCT04674839 ↗	The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals	Completed	Microbio Co Ltd	N/A	2019-10-18	MicrSoy-20 (MS-20), a fermented soymilk product, has been approved as an Over the counter (OTC) drug in 2011. The therapeutic effect of MS-20 is to ameliorate symptoms such as fatigue and loss of appetite caused by cancer chemotherapy. Animal study revealed orally administration of MS-20 daily for 4 weeks altered the gut microbiota composition in mice. In addition, MS-20 could activate dendritic cell and improve immunotherapy response rate. Thus, it was hypothesis that MS-20 improves host immune activity thus ameliorate fatigue and increase weight is through alteration the gut microbiota composition. In this study, the ability of MS-20 in modulating gut microbiota and the subset of microbiome to be altered by MS-20 was investigated.
New Dosage	NCT01734694 ↗	Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients	Terminated	Henry Ford Health System	Phase 4	2011-10-01	For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.
New Dosage	NCT01162733 ↗	Loading Vancomycin Doses in the Emergency Department	Completed	Christiana Care Health Services	N/A	2010-07-01	In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.

All Clinical Trials for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00079976 ↗	Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2003-10-01	To evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.
NCT00037050 ↗	Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria	Completed	Pfizer	Phase 3	2002-04-01	This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)
NCT00034294 ↗	A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea	Completed	Genzyme, a Sanofi Company	Phase 2	2002-02-01	Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.
NCT00035854 ↗	New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)	Completed	Pfizer	Phase 3	2002-02-01	This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
NCT00035425 ↗	Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection	Completed	Pfizer	Phase 3	2001-11-01	This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
NCT00057369 ↗	Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections	Unknown status	Vicuron Pharmaceuticals	Phase 2	2001-02-01	This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.
NCT00003805 ↗	Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1997-11-01	RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.

Clinical Trial Conditions for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Condition Name

Condition Name for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Clostridium Difficile Infection	38
Surgical Site Infection	20
Infection	18
Clostridium Difficile	14

Condition MeSH

Condition MeSH for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Infections	160
Infection	141
Communicable Diseases	128
Clostridium Infections	77

Clinical Trial Locations for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Location	Trials
Canada	94
Spain	42
United Kingdom	34
Brazil	34
Italy	31

Trials by US State

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−

Trials by US State for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Location	Trials
California	62
Texas	61
Ohio	53
Florida	51
New York	49

Clinical Trial Progress for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	119
Phase 3	89
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	191
Recruiting	69
Terminated	48

Clinical Trial Sponsors for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Sponsor	Trials
Cubist Pharmaceuticals LLC	23
Pfizer	18
Forest Laboratories	11

Sponsor Type

Sponsor Type for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Sponsor	Trials
Other	538
Industry	171
U.S. Fed	17

Vancomycin Hydrochloride in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

Vancomycin hydrochloride is a crucial antibiotic in the treatment of serious bacterial infections, particularly those resistant to other antibiotics. Here, we will delve into the clinical trials, market analysis, and projections for vancomycin hydrochloride, especially when administered in plastic containers.

Clinical Pharmacology and Administration

Vancomycin hydrochloride is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis. When administered intravenously, it achieves significant plasma concentrations. For example, a 1 g dose infused over 60 minutes results in mean plasma concentrations of approximately 63 mcg/mL immediately after infusion[3][4].

Intravenous Administration

Vancomycin hydrochloride in plastic containers, such as the GALAXY plastic container (PL 2040), is designed for intravenous use only. The solution is frozen, iso-osmotic, sterile, and nonpyrogenic, containing 500 mg or 1 g of vancomycin hydrochloride per 100 mL or 200 mL, respectively. The pH of the solution is adjusted to a range of 3.0 to 5.0 after thawing[3].

Clinical Trials and Bioequivalence Studies

Bioequivalence Studies for Oral Capsules

For oral vancomycin hydrochloride capsules, bioequivalence (BE) studies have evolved over time. Initially, the FDA recommended in vivo BE studies with clinical endpoints due to the limited utility of pharmacokinetic (PK) measurements following oral administration. However, in 2006, the FDA revised its recommendation to include in vitro dissolution studies for generic vancomycin hydrochloride capsules that are qualitatively (Q1) and quantitatively (Q2) the same as the reference listed drug (RLD) with respect to inactive ingredients. This approach is more sensitive in detecting differences in product performance and provides information about drug availability at the site of action[1].

Safety and Efficacy in Specific Populations

Clinical studies have evaluated the safety and efficacy of vancomycin hydrochloride in various populations. For instance, a controlled clinical study assessed the potential ototoxic and nephrotoxic effects of vancomycin in infants, highlighting the need for careful administration in vulnerable populations[3].

Market Analysis

Market Size and Growth

The global market for vancomycin hydrochloride is projected to grow significantly. In 2023, the market was estimated at $396.7 million and is expected to reach $555.5 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of around 6%[5].

Market Drivers

Several factors drive the growth of the vancomycin hydrochloride market:

• Increasing Prevalence of Antibiotic-Resistant Infections: The emergence of multi-drug-resistant bacterial strains, such as MRSA, necessitates the use of vancomycin as a last-line treatment option[2][5].
• Advancements in Pharmaceutical Manufacturing: Innovations in manufacturing processes and formulations expand market opportunities[2][5].
• Rising Awareness of Infection Control: Enhanced awareness and regulatory support for infection control measures in healthcare settings fuel market growth[2][5].

Market Restraints

Despite the growth potential, the market faces several challenges:

• Adverse Side Effects: The potential for ototoxicity, nephrotoxicity, and other side effects poses significant challenges[3][4].
• Stringent Regulatory Framework: The strict regulatory environment for new antibiotic approvals can impede market expansion[2].

Regional Analysis

The market is diverse across different regions:

• U.S. Market: Estimated at $103.9 million in 2023, the U.S. market is a significant segment[5].
• Asia-Pacific Market: Emerging markets in this region show promising growth potential, with China forecasted to grow at an impressive 8.2% CAGR to reach $130.4 million by 2030[5].

Market Opportunities

Unmet Demand for Oral Dosage Forms

The increasing prevalence of antibiotic-resistant infections creates an unmet demand for oral dosage forms of vancomycin hydrochloride, presenting a growth opportunity[2].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, offer promising growth potential due to favorable government policies and increasing healthcare needs[2][5].

Competitive Assessment and Intelligence

The competitive landscape of the vancomycin hydrochloride market is characterized by:

• Market Share and Strategic Approaches: Leading market players focus on strategic investments, product innovation, and regulatory approvals to maintain market share[2].
• Product Development and Innovation: Ongoing research and development in formulations and applications are crucial for sustaining market expansion[2].

Key Takeaways

• Clinical Trials and Bioequivalence: In vitro dissolution studies are recommended for generic vancomycin hydrochloride capsules that are Q1 and Q2 the same as the RLD, while in vivo BE studies with clinical endpoints are recommended for formulations that differ in inactive ingredients.
• Market Growth: The global vancomycin hydrochloride market is expected to grow from $396.7 million in 2023 to $555.5 million by 2030, driven by the increasing prevalence of antibiotic-resistant infections and advancements in pharmaceutical manufacturing.
• Regional Analysis: The U.S. and Asia-Pacific regions are significant markets, with China showing particularly strong growth potential.
• Market Opportunities: Unmet demand for oral dosage forms and emerging markets in the Asia-Pacific region present key growth opportunities.

FAQs

What is the primary use of vancomycin hydrochloride in healthcare settings?

Vancomycin hydrochloride is primarily used to treat serious bacterial infections resistant to other antibiotics, particularly those caused by MRSA.

How is vancomycin hydrochloride administered intravenously?

Vancomycin hydrochloride is administered intravenously in a frozen, iso-osmotic, sterile, and nonpyrogenic solution contained in plastic containers like the GALAXY plastic container (PL 2040).

What are the key drivers of the vancomycin hydrochloride market growth?

The key drivers include the increasing prevalence of antibiotic-resistant infections, advancements in pharmaceutical manufacturing, and rising awareness of infection control measures.

What are the main challenges facing the vancomycin hydrochloride market?

The main challenges include the potential for adverse side effects and the stringent regulatory framework for new antibiotic approvals.

Which regions are expected to show significant growth in the vancomycin hydrochloride market?

The U.S. and Asia-Pacific regions, particularly China, are expected to show significant growth in the coming years.

Sources

1. FDA Draft Guidance on Vancomycin Hydrochloride: accessdata.fda.gov
2. Vancomycin Hydrochloride Capsules Market Report: 360iresearch.com
3. Vancomycin Injection, USP in GALAXY Plastic Container: accessdata.fda.gov
4. Vancomycin Hydrochloride, USP VIAL Clinical Pharmacology: pfizermedicalinformation.com
5. Vancomycin Markets - Global Strategic Business Report Q4, 2024: globenewswire.com