CLINICAL TRIALS PROFILE FOR FLOXIN

All Clinical Trials for Floxin

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.
NCT00563394 ↗	MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers	Completed	Genaera Corporation	Phase 3	1994-08-01	224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.
NCT00563394 ↗	MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers	Completed	Abeona Therapeutics, Inc	Phase 3	1994-08-01	224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

Clinical Trial Conditions for Floxin

Condition Name

Condition Name for Floxin
Intervention	Trials
Otitis Media	2
Diabetic Foot Ulcers	2
Keratoplasty	1
Keratoplasty, Lamellar	1

Condition MeSH

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

Clinical Trial Locations for Floxin

Trials by Country

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

Trials by US State

Trials by US State for Floxin
Location	Trials
Washington	3
Oregon	2
New York	2
California	1
Colorado	1

Clinical Trial Progress for Floxin

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Floxin

Sponsor Name

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

Sponsor Type

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

Clinical Trials, Market Analysis, and Projections for Floxin (Ofloxacin)

Introduction to Floxin (Ofloxacin)

Floxin, also known as ofloxacin, is a fluoroquinolone antibiotic used to treat various bacterial infections. It is available in several forms, including oral tablets, injectable solutions, and otic (ear) drops. Here, we will delve into the clinical trials, market analysis, and projections for Floxin.

Clinical Trials and Safety Profile

Historical Clinical Trials

Floxin has undergone extensive clinical trials, particularly in its phase III stages, which formed the basis for its approval. In these trials, the drug was evaluated for its efficacy and safety in treating conditions such as acute otitis media with tympanostomy tubes (AOM TT) and chronic suppurative otitis media (CSOM)[4].

Adverse Events

The clinical trials revealed several treatment-related adverse events. For instance, in phase III trials involving 656 subjects with non-intact tympanic membranes, common adverse events included taste perversion (7%), earache (1%), pruritus (1%), paraesthesia (1%), rash (1%), and dizziness (1%)[4].

FDA Safety Updates

The FDA has issued several safety updates regarding fluoroquinolones, including Floxin. These updates highlight the risk of disabling side effects such as tendinitis, tendon rupture, and peripheral neuropathy. The FDA has also noted that these side effects can occur within hours to weeks after starting the medication and may persist for months or even years after discontinuation[1].

Market Analysis

Global Market for Fluoroquinolones

The market for fluoroquinolones, including Floxin, is influenced by several factors, including the prevalence of bacterial infections and the availability of alternative antibiotics. The global Levofloxacin Hemihydrate market, another fluoroquinolone, provides some insight into the broader market trends. For example, the global Levofloxacin Hemihydrate market volume was approximately 36 thousand tonnes in 2023 and is expected to grow at a CAGR of 5% during the forecast period[2].

Regional Market Dynamics

North America is a significant consumer of fluoroquinolones, including Floxin. The region's demand is driven by the high incidence of bacterial infections and the well-established healthcare infrastructure[2].

Market Projections

Pharmaceutical Market Outlook

The overall pharmaceutical market, including antibiotics like Floxin, is expected to see stable growth. According to the Pharmacy Market Outlook for 2025, the projected overall drug price inflation rate is expected to be around 0%, indicating a stable pricing environment for pharmaceuticals[5].

Specific Projections for Floxin

While specific projections for Floxin are not readily available, the general trend for fluoroquinolones suggests a steady demand due to their efficacy in treating bacterial infections. However, the market growth may be tempered by the increasing awareness and regulatory scrutiny of the side effects associated with these drugs.

Impact of Gene Therapy and Advanced Treatments

The emergence of gene therapies and other advanced treatments may also influence the market dynamics for traditional antibiotics like Floxin. With over 280 gene therapies in various stages of development, there is a potential shift towards more innovative and possibly curative treatments, which could impact the long-term demand for antibiotics[5].

Regulatory Environment

FDA Oversight

Clinical trials for Floxin and other fluoroquinolones are rigorously regulated by the FDA to ensure patient safety and data integrity. The FDA's updates on safety warnings and the re-evaluation of the risks and benefits of these drugs are critical in shaping their market presence[1][3].

Key Takeaways

• Clinical Trials: Floxin has undergone extensive clinical trials, highlighting its efficacy but also revealing potential adverse events.
• Market Analysis: The global market for fluoroquinolones is significant, with North America being a major consumer.
• Market Projections: The market for Floxin is expected to remain stable, though it may be influenced by regulatory scrutiny and the emergence of advanced treatments.
• Regulatory Environment: The FDA plays a crucial role in regulating and monitoring the safety of fluoroquinolones.

FAQs

What are the common adverse events associated with Floxin?

Common adverse events include taste perversion, earache, pruritus, paraesthesia, rash, and dizziness[4].

How does the FDA regulate fluoroquinolones like Floxin?

The FDA rigorously regulates these drugs, issuing safety updates and re-evaluating their risks and benefits to ensure patient safety[1].

What is the projected market growth for fluoroquinolones like Floxin?

The market is expected to grow steadily, though at a moderate rate, influenced by regulatory scrutiny and the emergence of advanced treatments[2][5].

Are there any regional differences in the consumption of Floxin?

Yes, North America is a significant consumer of fluoroquinolones, driven by the high incidence of bacterial infections and a well-established healthcare infrastructure[2].

How do gene therapies impact the market for traditional antibiotics like Floxin?

Gene therapies could potentially reduce the demand for traditional antibiotics by offering more innovative and curative treatments for chronic diseases[5].

Sources

1. FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. FDA, 26 July 2016.
2. Levofloxacin Hemihydrate Market Size, Share & Forecast 2034. ChemAnalyst.
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033. BioSpace, 26 April 2024.
4. FLOXIN® Otic - MDEdge. MDEdge.
5. Pharmacy Market Outlook Summer 2024 - Vizient Inc. Vizient Inc.