CLINICAL TRIALS PROFILE FOR FLOXIN OTIC

All Clinical Trials for Floxin Otic

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Eastern Cooperative Oncology Group	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Gary Morrow	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00419380 ↗	Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)	Completed	Genentech, Inc.	Phase 4	2007-01-01	The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the new drug for any problems related to the medication. Patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes. This problem occasionally is improved with ear drops like Floxin®. However, it is frequently not improved even after this standard ear drop treatment.
NCT00419380 ↗	Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)	Completed	University of Colorado, Denver	Phase 4	2007-01-01	The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the new drug for any problems related to the medication. Patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes. This problem occasionally is improved with ear drops like Floxin®. However, it is frequently not improved even after this standard ear drop treatment.

Clinical Trial Conditions for Floxin Otic

Condition Name

Condition Name for Floxin Otic
Intervention	Trials
Diabetic Foot Ulcers	2
Otitis Media	2
Transplantation, Corneal	1
Acute Otitis Media	1

Condition MeSH

Condition MeSH for Floxin Otic
Intervention	Trials
Otitis Media	3
Ulcer	2
Foot Ulcer	2
Diabetic Foot	2

Clinical Trial Locations for Floxin Otic

Trials by Country

Trials by Country for Floxin Otic
Location	Trials
United States	23
Peru	1
South Africa	1

Trials by US State

Trials by US State for Floxin Otic
Location	Trials
Washington	3
New York	2
Oregon	2
North Carolina	1
New Jersey	1

Clinical Trial Progress for Floxin Otic

Clinical Trial Phase

Clinical Trial Phase for Floxin Otic
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6

Clinical Trial Status

Clinical Trial Status for Floxin Otic
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	1
Enrolling by invitation	1

Clinical Trial Sponsors for Floxin Otic

Sponsor Name

Sponsor Name for Floxin Otic
Sponsor	Trials
Genaera Corporation	2
Abeona Therapeutics, Inc	2
MacroChem Corporation	2

Sponsor Type

Sponsor Type for Floxin Otic
Sponsor	Trials
Industry	10
Other	8
NIH	1

FLOXIN OTIC: Clinical Trials, Market Analysis, and Projections

Introduction

FLOXIN OTIC, which contains ofloxacin, a synthetic fluoroquinolone antibacterial agent, is widely used for the treatment of various ear infections, including otitis externa and otitis media. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Efficacy and Safety of FLOXIN OTIC

Clinical Trials Overview

Clinical trials have consistently shown that ofloxacin otic solution is highly effective in treating ear infections. A Phase III study demonstrated that ofloxacin otic 0.3% solution administered once daily for 7 days was well tolerated and effective in achieving both clinical and microbiologic cure of otitis externa (OE)[4].

• Efficacy: The study involved 489 patients and showed a cure rate of 91% among clinically evaluable patients, with 95% of children and 88% of adolescents/adults achieving cure. The eradication rate for potentially pathogenic strains was 96% overall[4].
• Safety: The solution was well tolerated, with minor adverse events experienced by only 3% of the patients. The most common adverse events were pruritus, increased earache, and application-site reactions[4].

Another study compared ofloxacin otic 0.3% solution to neomycin/polymyxin B/hydrocortisone preparations and found that ofloxacin was as effective, with a clinical cure rate of over 80% in adults and over 95% in children[3].

Comparison with Other Treatments

Ofloxacin otic solution has been compared to other topical and oral antibiotics. It was found to be as effective as neomycin/polymyxin B/hydrocortisone preparations and oral amoxicillin/clavulanic acid in treating otitis media and otitis externa[3].

Market Analysis

Global Market Size and Growth

The global ofloxacin market, which includes FLOXIN OTIC, has seen significant growth in recent years and is expected to continue this trend. The market size was robust in 2020 and is projected to register double-digit revenue growth over the forecast period[5].

Key Drivers

Several factors are driving the growth of the ofloxacin market:

• Increasing Prevalence of Bacterial Infections: The rising prevalence of bacterial infections, including those caused by multidrug-resistant bacterial species, is a major driver[5].
• Therapeutic Effectiveness: Ofloxacin's broad-spectrum activity and high efficacy in treating various infections, including lower respiratory tract infections, skin and skin structure infections, urinary tract infections, and sexually transmitted diseases, contribute to its market growth[5].
• Regional Health Infrastructure: North America is expected to register significant revenue growth due to the availability of state-of-the-art healthcare infrastructure and increasing concerns regarding health[5].

Market Segmentation

The global ofloxacin market is segmented based on type, applications, distribution channels, and geography:

• Type: Oral, intravenous therapy (IV), and topical (eye drops and ear drops). The oral segment holds the largest share due to its high bioavailability[2].
• Distribution Channels: Hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to account for a significant revenue share due to the prescription nature of the drug[5].

Market Projections

Regional Analysis

• North America: Expected to hold the largest market share due to the advanced healthcare system and high demand for branded products[2][5].
• Asia Pacific: Expected to grow at the highest CAGR due to the increasing prevalence of infectious diseases and a large population base[2].

Future Trends

• Increasing Use in Various Infections: Ofloxacin is expected to replace other antibacterial drugs to some extent due to its beneficial properties, such as good oral absorption, easy tissue penetration, and broad-spectrum activity[2].
• Emergence of New Infectious Diseases: Growing awareness and the emergence of new infectious diseases with bacterial resistance are expected to generate huge opportunities for the ofloxacin market[2].

Challenges and Limitations

Adverse Events

While ofloxacin otic solution is generally well tolerated, there are some adverse events to consider:

• Systemic Adverse Events: Although rare, systemic adverse events such as tendon rupture, especially in older patients taking corticosteroids, and muscle weakness in myasthenia gravis patients, can occur[2].
• Local Adverse Events: Common local adverse events include bitter taste, primarily in patients with non-intact tympanic membranes, and pruritus[3].

Key Takeaways

• Clinical Efficacy: FLOXIN OTIC has been shown to be highly effective in treating otitis externa and otitis media with high clinical and microbiologic cure rates.
• Market Growth: The global ofloxacin market is expected to grow significantly due to the increasing prevalence of bacterial infections and the drug's broad-spectrum activity.
• Regional Trends: North America and the Asia Pacific region are key markets, with the latter expected to grow at the highest CAGR.
• Challenges: While generally well tolerated, ofloxacin can have systemic and local adverse events that need to be considered.

FAQs

What is FLOXIN OTIC used for?

FLOXIN OTIC is used for the treatment of otitis externa and otitis media, including infections of the external auditory canal and middle ear.

How effective is FLOXIN OTIC in clinical trials?

Clinical trials have shown that FLOXIN OTIC achieves high clinical and microbiologic cure rates, with a cure rate of 91% among clinically evaluable patients[4].

What are the common adverse events associated with FLOXIN OTIC?

Common adverse events include pruritus, increased earache, and application-site reactions. Systemic adverse events such as tendon rupture can occur, especially in older patients taking corticosteroids[2][3].

Which regions are expected to drive the growth of the ofloxacin market?

North America and the Asia Pacific region are expected to drive the growth of the ofloxacin market, with the latter growing at the highest CAGR[2][5].

Why is the ofloxacin market growing?

The ofloxacin market is growing due to the increasing prevalence of bacterial infections, the emergence of multidrug-resistant bacterial strains, and the drug's broad-spectrum activity and high efficacy[5].

Sources

1. Chu L, Acosta AM, Aazami H, et al. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(7):e2221699. doi:10.1001/jamanetworkopen.2022.21699
2. Verified Market Research. Ofloxacin Market Size | Share | Industry Analysis | Trends | Forecast.
3. PubMed. Ofloxacin otic solution: a review of its use in the management of ear infections.
4. PubMed. Efficacy of ofloxacin otic solution once daily for 7 days in the treatment of otitis externa.
5. Reports and Data. Ofloxacin Market Share, Trends & Analysis | Global Report.