CLINICAL TRIALS PROFILE FOR FIRVANQ KIT

All Clinical Trials for firvanq kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06148025 ↗	Antibiotics and Vaccine Immune Responses Study	Recruiting	Centenary Institute of Cancer Medicine and Cell Biology	Phase 4	2023-11-23	The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?
NCT06148025 ↗	Antibiotics and Vaccine Immune Responses Study	Recruiting	Flinders University	Phase 4	2023-11-23	The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?
NCT06148025 ↗	Antibiotics and Vaccine Immune Responses Study	Recruiting	Royal Adelaide Hospital	Phase 4	2023-11-23	The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?
NCT06148025 ↗	Antibiotics and Vaccine Immune Responses Study	Recruiting	Telethon Kids Institute	Phase 4	2023-11-23	The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?
NCT06148025 ↗	Antibiotics and Vaccine Immune Responses Study	Recruiting	University of Sydney	Phase 4	2023-11-23	The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?
NCT06148025 ↗	Antibiotics and Vaccine Immune Responses Study	Recruiting	South Australian Health and Medical Research Institute	Phase 4	2023-11-23	The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?

Clinical Trial Conditions for firvanq kit

Condition Name

Condition Name for firvanq kit
Intervention	Trials
Vaccine Response Impaired	1

Condition MeSH

Condition MeSH for firvanq kit
Intervention	Trials

Clinical Trial Locations for firvanq kit

Trials by Country

Trials by Country for firvanq kit
Location	Trials
Australia	1

Clinical Trial Progress for firvanq kit

Clinical Trial Phase

Clinical Trial Phase for firvanq kit
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for firvanq kit
Clinical Trial Phase	Trials
Recruiting	1

Clinical Trial Sponsors for firvanq kit

Sponsor Name

Sponsor Name for firvanq kit
Sponsor	Trials
Centenary Institute of Cancer Medicine and Cell Biology	1
Flinders University	1
Royal Adelaide Hospital	1

Sponsor Type

Sponsor Type for firvanq kit
Sponsor	Trials
Other	6

Firvanq kit Market Analysis and Financial Projection

Firvanq Kit: Clinical Trials, Market Analysis, and Projections

Introduction

Firvanq, a vancomycin hydrochloride oral solution, is a crucial medication for treating Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Here, we delve into the clinical trials, market analysis, and future projections for Firvanq.

Clinical Trials and Approval

Approval Process

Firvanq was approved by the FDA without additional clinical trials beyond those already conducted for vancomycin. It shares the same contraindications, warnings, and precautions as vancomycin. The drug is indicated for use in adults and pediatric patients for the specified infections[1].

Efficacy and Safety

The efficacy of Firvanq is based on the established efficacy of vancomycin. Guidelines from IDSA/SHEA 2017 recommend vancomycin or fidaxomicin over metronidazole for the initial episode of C. difficile in adults. For children, vancomycin is recommended for severe cases of C. difficile infection[1].

Market Analysis

Current Market Position

Firvanq is the only FDA-approved vancomycin hydrochloride for oral solution, making it a unique product in the market. It is supplied as kits containing vancomycin powder and a grape-flavored diluent, which must be reconstituted by healthcare providers[1].

Pricing

The cost for Firvanq (50 mg/mL) oral powder for reconstitution is approximately $159 for a 150 milliliter supply, depending on the pharmacy. This price is for cash-paying customers and does not apply to insurance plans. Generic versions of vancomycin are also available, which can affect the pricing dynamics[5].

Recall and Safety Concerns

Recent Recall

In 2021, Azurity Pharmaceuticals Inc. issued a voluntary nationwide recall of one lot of Firvanq due to the incorrect inclusion of a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent. This could lead to inappropriate doses of vancomycin, potentially causing severe complications, especially in elderly and immunocompromised patients[2][4].

Market Projections

Global Antibiotic Market

The global antibiotic market, within which Firvanq operates, is expected to grow due to increasing antibiotic resistance and the need for effective treatments. The specific segment for Clostridium difficile treatments is particularly relevant given the rising incidence of C. difficile infections.

Clinical Trial Kits Market

While Firvanq itself is not primarily a clinical trial kit, the broader market for clinical trial kits is growing. This market was valued at $2.3 billion in 2020 and is expected to grow at a CAGR of 12.5% to reach $5.1 billion by 2030. The growth is driven by the globalization of clinical trials, increasing demand for remote services, and rising clinical trial complexity[3].

Competitive Landscape

Key Players

Although Firvanq is a unique product, the broader antibiotic and clinical trial markets involve several key players. In the clinical trial kits market, companies like Brooks Life Science, Q2 Solutions, Patheon (Thermo Fisher Scientific), and others are significant players. However, Firvanq's market is more niche, focusing on vancomycin treatments for specific infections[3].

Regional Market Analysis

Asia Pacific

The Asia Pacific region is expected to witness significant growth in the pharmaceutical market, including antibiotics. With over 60% of the world's population, this region has a vast patient pool, many of whom remain treatment-naive due to limited access to affordable medical alternatives. This could drive demand for antibiotics like Firvanq in the future[3].

Key Takeaways

• Clinical Trials: Firvanq was approved based on existing vancomycin trials.
• Market Position: It is the only FDA-approved vancomycin hydrochloride for oral solution.
• Pricing: Approximately $159 for a 150 milliliter supply.
• Recall: Recent recall due to incorrect diluent, highlighting safety concerns.
• Market Projections: Growth expected in the antibiotic market, driven by increasing resistance and need for effective treatments.
• Regional Growth: Asia Pacific region expected to see significant growth due to a large patient pool.

FAQs

What is Firvanq used for?

Firvanq is used for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains[1].

Why was Firvanq recalled in 2021?

Firvanq was recalled in 2021 because some products in the affected lot contained an incorrect diluent, which could lead to inappropriate doses of vancomycin and severe complications[2][4].

How much does Firvanq cost?

The cost for Firvanq (50 mg/mL) oral powder for reconstitution is approximately $159 for a 150 milliliter supply, depending on the pharmacy[5].

Is Firvanq available in generic form?

Yes, a generic version of vancomycin is available, which can affect the pricing dynamics of Firvanq[5].

What are the potential risks associated with the incorrect diluent in Firvanq?

The incorrect diluent could lead to doses above or below the recommended levels, resulting in persistent diarrhea, dehydration, electrolyte abnormalities, recurrence of C. difficile infection, and potentially severe colitis or death, especially in vulnerable patients[2].

Sources

1. Geisinger Health Plan Family Pharmaceutical and Therapy Committee Meeting Minutes, September 18, 2018.
2. FDA Recall Notice: Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Firvanq, September 8, 2021.
3. Clinical Trial Kits Market 2021 by Size, Share, Regions, Type and Application, Forecast to 2030, Biospace, May 19, 2022.
4. Recall of Firvanq Oral Solution 50mg/mL Kit, Horizon NJ Health, October 13, 2021.
5. Firvanq Prices, Coupons, Copay Cards & Patient Assistance, Drugs.com.