CLINICAL TRIALS PROFILE FOR OXYTROL

505(b)(2) Clinical Trials for Oxytrol

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	NCT04534491 ↗	Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream.	Completed	Bayer	Phase 3	2010-05-25	With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. An area of focus was on the potential benefits of an over-the-counter status for Oxytrol and on the ongoing use behavior of the consumers. Oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive bladder a disease characterized by a collection of symptoms, including urinary frequency, urgency, and urge incontinence. The adhesive patch is placed on the skin to deliver Oxytrol through the skin into the bloodstream.

All Clinical Trials for Oxytrol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00224016 ↗	Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition	Completed	Watson Pharmaceuticals	Phase 4	2004-12-01	This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
NCT00224029 ↗	A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition	Completed	Watson Pharmaceuticals	Phase 4	2004-12-01	This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
NCT00224146 ↗	Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder	Completed	Watson Pharmaceuticals	Phase 4	2004-05-01	This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)
NCT01050114 ↗	OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER	Unknown status	Christopher Patrick Smith	Phase 3	2013-08-01	Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine). OnaBoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold. This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases. Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg capsule twice a day. The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo contains no active medicine. Participation in this study will be about 6-7 months and involve 5 visits to the clinic. The risks of bladder onaBoNT-A

Clinical Trial Conditions for Oxytrol

Condition Name

Condition Name for Oxytrol
Intervention	Trials
Overactive Bladder	4
Detrusor Hyperreflexia	2
Quality of Life	1
Urinary Bladder Diseases	1

Condition MeSH

Condition MeSH for Oxytrol
Intervention	Trials
Urinary Bladder, Overactive	4
Urinary Incontinence	2
Enuresis	2
Reflex, Abnormal	2

Clinical Trial Locations for Oxytrol

Trials by Country

Trials by Country for Oxytrol
Location	Trials
United States	66
Canada	4

Trials by US State

Trials by US State for Oxytrol
Location	Trials
Texas	5
North Carolina	4
New York	4
Georgia	3
Missouri	3

Clinical Trial Progress for Oxytrol

Clinical Trial Phase

Clinical Trial Phase for Oxytrol
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2

Clinical Trial Status

Clinical Trial Status for Oxytrol
Clinical Trial Phase	Trials
Completed	6
Unknown status	1

Clinical Trial Sponsors for Oxytrol

Sponsor Name

Sponsor Name for Oxytrol
Sponsor	Trials
Watson Pharmaceuticals	3
Astellas Scientific & Medical Affairs, Inc.	1
Bayer	1

Sponsor Type

Sponsor Type for Oxytrol
Sponsor	Trials
Industry	5
Other	4

OXYTROL: Clinical Trials, Market Analysis, and Projections

Introduction to OXYTROL

OXYTROL, a transdermal system containing oxybutynin, is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and frequency. Here, we will delve into the clinical trials, market analysis, and projections for this medication.

Clinical Trials Overview

Phase I Clinical Trials

The initial Phase I clinical trial of OXYTROL was conducted between September 2008 and January 2009. This randomized, double-blind study enrolled over 60 women with OAB, aged between 40 and 75 years. The primary outcome measure was the comparison of maximum cystometric capacity at steady state after four hours of treatment with OXYTROL or placebo. Secondary outcomes included comparisons of maximum cystometric capacity four hours post-dose of OXYTROL versus placebo[4].

Phase III Clinical Trials

The FDA approval of OXYTROL for Women was based on two Phase III controlled clinical studies and one open-label study.

First Phase III Study

This randomized, double-blind, placebo-controlled study involved 520 subjects. Patients were administered OXYTROL at dose levels of 1.3 mg, 2.6 mg, and 3.9 mg/day or placebo. The results showed significant reductions in weekly incontinence episodes, urinary frequency, and urinary void volume in patients treated with OXYTROL compared to placebo. The study was extended with an open-label treatment for up to an additional 40 weeks, further confirming the efficacy of OXYTROL in reducing urge or mixed incontinence episodes[4].

Second Phase III Study

This study was a randomized, double-blind, double-dummy trial comparing the safety and efficacy of OXYTROL 3.9 mg/day to active and placebo controls. It enrolled over 361 patients and demonstrated that OXYTROL-administered patients had significant reductions in daily incontinence episodes, urinary frequency, and urinary void volume compared to both placebo and active treatment groups[4].

Safety and Efficacy Findings

In both pivotal studies, OXYTROL was well-tolerated. The most common adverse reactions included application site pruritus, dry mouth, application site erythema, and other mild to moderate skin reactions. No deaths or serious adverse events related to treatment were reported. The studies also showed that OXYTROL significantly reduced daily incontinence episodes, urinary frequency, and increased urinary void volume compared to placebo[1][2].

Market Analysis

Current Market

The U.S. overactive bladder (OAB) market is substantial, exceeding $1.8 billion annually and continues to grow each year. OXYTROL, with its unique transdermal delivery system, has carved out a niche in this market by offering a convenient and effective treatment option for patients[5].

Competitive Landscape

OXYTROL competes with other anticholinergic medications and treatments for OAB. However, its transdermal system provides a distinct advantage by bypassing first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite and thereby minimizing side effects such as dry mouth, which are common with oral anticholinergics[2].

Consumer Acceptance

The transition of OXYTROL from a prescription (Rx) to an over-the-counter (OTC) product has been supported by consumer label comprehension and self-selection studies. These studies, including the actual use study (CL2008-13), have shown that consumers can effectively understand and use the product, indicating strong potential for market acceptance in the OTC segment[3].

Market Projections

Growth Potential

Given the growing demand for OAB treatments and the unique benefits of OXYTROL’s transdermal system, the market for this drug is expected to grow. The convenience and reduced side effect profile compared to oral medications make it an attractive option for patients, which could drive increased adoption and market share.

Demographic Trends

The majority of patients in clinical trials were Caucasian and female, with a mean age of 61-64 years. As the population ages, the incidence of OAB is likely to increase, providing a larger potential market for OXYTROL. Additionally, the product’s approval for women and potential future approvals for other demographics could further expand its market reach[1][2].

Regulatory Environment

The FDA approval process and subsequent label updates have been iterative, with a focus on ensuring consumer comprehension and safe use. This regulatory support is crucial for maintaining and expanding market presence, especially as the product transitions to OTC status[3].

Key Takeaways

• Clinical Efficacy: OXYTROL has demonstrated significant reductions in incontinence episodes, urinary frequency, and increased urinary void volume in clinical trials.
• Safety Profile: The drug is generally well-tolerated with mild to moderate adverse reactions, primarily related to the application site.
• Market Potential: The growing OAB market and the unique benefits of OXYTROL’s transdermal system position it for continued growth.
• Consumer Acceptance: Studies have shown strong consumer comprehension and acceptance, particularly as the product moves to OTC status.

FAQs

1. What is OXYTROL used for?

OXYTROL is used for the treatment of overactive bladder symptoms, including urge urinary incontinence, urgency, and frequency.

2. How is OXYTROL administered?

OXYTROL is administered via a transdermal system, applied twice weekly to dry, intact skin on the abdomen, hip, or buttocks.

3. What are the common side effects of OXYTROL?

Common side effects include application site pruritus, dry mouth, application site erythema, and other mild to moderate skin reactions.

4. Is OXYTROL available over-the-counter?

Yes, OXYTROL has been approved for transition from prescription to over-the-counter status, particularly for women aged 18 and older.

5. What demographic is most likely to use OXYTROL?

The majority of patients in clinical trials were Caucasian women with a mean age of 61-64 years, but the product is indicated for both men and women with OAB symptoms.

Cited Sources

1. FDA Prescribing Information: Highlights of Prescribing Information - OXYTROL.
2. Drugs.com: Oxytrol: Package Insert / Prescribing Information.
3. FDA Statistical Review: 202211s000 - OXYTROL for Women.
4. Clinical Trials Arena: Oxytrol (oxybutynin) for the Treatment of Overactive Bladder (OAB) in Women.
5. BioSpace: Watson Pharmaceuticals, Inc. New Data Presented at American Urological Association's Annual Conference.