CLINICAL TRIALS PROFILE FOR TEFLARO

505(b)(2) Clinical Trials for TEFLARO

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
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.

All Clinical Trials for TEFLARO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01524302 ↗	Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia	Completed	Forest Laboratories	Phase 4	2012-02-01	This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.
NCT01400867 ↗	Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections	Completed	AstraZeneca	Phase 2/Phase 3	2011-12-01	This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
NCT01400867 ↗	Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections	Completed	Forest Laboratories	Phase 2/Phase 3	2011-12-01	This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.

Clinical Trial Conditions for TEFLARO

Condition Name

Condition Name for TEFLARO
Intervention	Trials
Infections	3
Bacteremia	2
Osteomyelitis	1

Condition MeSH

Condition MeSH for TEFLARO
Intervention	Trials
Pneumonia	5
Infections	4
Infection	4

Clinical Trial Locations for TEFLARO

Trials by Country

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−

Trials by Country for TEFLARO
Location	Trials
United States	55
Georgia	4
Greece	4
Argentina	3
Romania	3

Trials by US State

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−

Trials by US State for TEFLARO
Location	Trials
California	5
Ohio	5
Michigan	5
Florida	4
West Virginia	3

Clinical Trial Progress for TEFLARO

Clinical Trial Phase

Clinical Trial Phase for TEFLARO
Clinical Trial Phase	Trials
Phase 4	8
Phase 2/Phase 3	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for TEFLARO
Clinical Trial Phase	Trials
Completed	7
Unknown status	3
Terminated	1

Clinical Trial Sponsors for TEFLARO

Sponsor Name

Sponsor Name for TEFLARO
Sponsor	Trials
Forest Laboratories	10
AstraZeneca	3
Henry Ford Health System	1

Sponsor Type

Sponsor Type for TEFLARO
Sponsor	Trials
Industry	13
Other	8

TEFLARO (Ceftaroline Fosamil): Clinical Trials, Market Analysis, and Projections

Introduction

TEFLARO (ceftaroline fosamil) is a cephalosporin antibiotic approved for the treatment of adult and pediatric patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Adult Studies

TEFLARO has been extensively studied in adult patients. In the FOCUS trials, which compared ceftaroline to ceftriaxone in treating CABP, TEFLARO demonstrated clinical cure rates comparable to ceftriaxone against common pathogens such as Streptococcus pneumoniae, Staphylococcus aureus (MSSA), Haemophilus influenzae, Klebsiella pneumoniae, and Escherichia coli[1][2].

• CABP Trials: TEFLARO showed pooled clinical cure rates of 85.7% against S. pneumoniae, 72.0% against S. aureus (MSSA), and 100% against K. pneumoniae, among other pathogens[1].
• ABSSSI Trials: TEFLARO was effective against MRSA and other susceptible bacteria, making it a valuable option for treating skin and skin structure infections[2].

Pediatric Studies

In 2016, the FDA approved TEFLARO for use in pediatric patients aged 2 months to less than 18 years for both ABSSSI and CABP. Clinical studies in pediatric patients showed efficacy and safety profiles similar to those in adults.

• Clinical Response: In pediatric CABP studies, the clinical response at Study Day 4 was 69.2% for TEFLARO, comparable to the comparator group. Clinical cure rates at the test of cure (TOC) visit were 87.9% for TEFLARO-treated patients[3].

Market Analysis

Market Size and Growth

The global ceftaroline fosamil market has seen significant growth. As of 2023, the market size was substantial, and it is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2031[5].

• Regional Analysis: The market is segmented into regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region contributes significantly to the overall market size and growth[5].

Market Trends and Drivers

Several factors drive the market for ceftaroline fosamil:

• Increasing Antibiotic Resistance: The rise in antibiotic-resistant bacteria, particularly MRSA, has increased the demand for effective antibiotics like TEFLARO[2].
• Expanded Indications: The approval for pediatric use has expanded the market potential for TEFLARO[3].
• Safety and Efficacy: TEFLARO's safety profile and efficacy against a broad spectrum of pathogens make it a preferred choice among healthcare providers[2].

Market Restraints

Despite its advantages, there are some restraints to the market growth:

• Generic Alternatives: The availability of generic alternatives to IV antibiotics could limit the commercial potential of TEFLARO[2].
• Limited Coverage: TEFLARO does not cover resistant gram-negative organisms, which might restrict its use in certain cases[2].

Market Projections

Revenue Forecast

The global ceftaroline fosamil market is expected to grow significantly from 2024 to 2031. The forecast includes revenue growth at the global, regional, and country levels[5].

• Peak Sales: Worldwide annual sales of TEFLARO could reach a peak of $650 million, according to some estimates[2].

Regional Growth

The market growth will be driven by various regions, with North America and Europe expected to be major contributors due to their advanced healthcare systems and higher adoption rates of new antibiotics.

• Emerging Markets: Asia Pacific and Latin America are also expected to show significant growth due to increasing healthcare spending and the need for effective antibiotics[5].

Safety and Dosage

Safety Profile

TEFLARO has a safety profile compatible with other cephalosporins. Common adverse reactions include GI upset, rash, and pseudomembranous colitis. It is also important to monitor for hemolytic anemia if a positive Coombs test occurs[2][4].

Dosage

TEFLARO is administered via IV infusion over 1 hour for adults and can be adjusted based on renal function. For pediatric patients, the dosage is based on age and weight[2][4].

Conclusion

TEFLARO (ceftaroline fosamil) is a valuable antibiotic in the treatment of CABP and ABSSSI, particularly due to its efficacy against MRSA and other susceptible pathogens. The drug has undergone extensive clinical trials, demonstrating its safety and efficacy in both adult and pediatric populations.

Key Takeaways

• Clinical Efficacy: TEFLARO has shown comparable clinical cure rates to ceftriaxone in treating CABP and is effective against MRSA in ABSSSI.
• Pediatric Approval: FDA approval for pediatric use has expanded the market potential.
• Market Growth: The global ceftaroline fosamil market is projected to grow significantly from 2024 to 2031.
• Safety Profile: TEFLARO has a safety profile consistent with other cephalosporins.

FAQs

Q: What are the approved indications for TEFLARO?

A: TEFLARO is approved for the treatment of adult and pediatric patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible pathogens[2][4].

Q: How does TEFLARO compare to other antibiotics in clinical trials?

A: TEFLARO has shown clinical cure rates comparable to ceftriaxone in treating CABP and is effective against MRSA in ABSSSI trials[1][2].

Q: What is the safety profile of TEFLARO?

A: Common adverse reactions include GI upset, rash, and pseudomembranous colitis. It is also important to monitor for hemolytic anemia if a positive Coombs test occurs[2][4].

Q: How is TEFLARO administered?

A: TEFLARO is administered via IV infusion over 1 hour for adults and can be adjusted based on renal function. For pediatric patients, the dosage is based on age and weight[2][4].

Q: What are the market projections for TEFLARO?

A: The global ceftaroline fosamil market is expected to grow significantly from 2024 to 2031, with projected peak sales of $650 million[2][5].

Sources

1. TEFLARO® (ceftaroline fosamil) Efficacy in CABP - TEFLARO.
2. Teflaro - MM+M - Medical Marketing and Media - MM+M.
3. Allergan Receives FDA Approval of TEFLARO® (ceftaroline fosamil) for Pediatric Patients - PR Newswire.
4. ABSSSI & CABP IV Therapy TEFLARO® (ceftaroline fosamil) - TEFLARO.
5. Ceftaroline Fosamil Market Report 2024 (Global Edition) - Cognitive Market Research.