CLINICAL TRIALS PROFILE FOR GELNIQUE 3%

All Clinical Trials for GELNIQUE 3%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01192568 ↗	Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder	Recruiting	Allergan	Phase 4	2011-05-02	This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
NCT01192568 ↗	Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder	Recruiting	Watson Pharmaceuticals	Phase 4	2011-05-02	This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
NCT02386072 ↗	A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)	Completed	Astellas Scientific & Medical Affairs, Inc.		2015-01-05	A study to identify factors that are associated with improved effectiveness in pharmacologic therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF (Overactive Bladder Questionnaire Short Form)
NCT02633371 ↗	A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults	Completed	Society for Pediatric Dermatology	N/A	2016-02-01	This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
NCT02633371 ↗	A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults	Completed	University of Colorado, Denver	N/A	2016-02-01	This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
NCT02961790 ↗	Oxybutynin Chloride in Managing Hot Flashes	Completed	National Cancer Institute (NCI)	Phase 3	2016-12-09	This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects. ADAM-VTE
NCT02961790 ↗	Oxybutynin Chloride in Managing Hot Flashes	Completed	Academic and Community Cancer Research United	Phase 3	2016-12-09	This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects. ADAM-VTE

Clinical Trial Conditions for GELNIQUE 3%

Condition Name

Condition Name for GELNIQUE 3%
Intervention	Trials
No Evidence of Disease	1
Overactive Bladder	1
Overactive Detrusor	1
Bothered by Hot Flashes	1

Condition MeSH

Condition MeSH for GELNIQUE 3%
Intervention	Trials
Urinary Bladder, Overactive	2
Polyneuropathies	1
Carcinoma	1
Diabetic Neuropathies	1

Clinical Trial Locations for GELNIQUE 3%

Trials by Country

Trials by Country for GELNIQUE 3%
Location	Trials
United States	58
Canada	4

Trials by US State

Trials by US State for GELNIQUE 3%
Location	Trials
North Carolina	3
Michigan	3
Colorado	3
Virginia	3
Ohio	2

Clinical Trial Progress for GELNIQUE 3%

Clinical Trial Phase

Clinical Trial Phase for GELNIQUE 3%
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
N/A	1

Clinical Trial Status

Clinical Trial Status for GELNIQUE 3%
Clinical Trial Phase	Trials
Completed	4
Recruiting	1

Clinical Trial Sponsors for GELNIQUE 3%

Sponsor Name

Sponsor Name for GELNIQUE 3%
Sponsor	Trials
Eastern Virginia Medical School	1
Allergan	1
Watson Pharmaceuticals	1

Sponsor Type

Sponsor Type for GELNIQUE 3%
Sponsor	Trials
Industry	4
Other	4
NIH	2

GELNIQUE 3%: Clinical Trials, Market Analysis, and Projections

Last updated: January 3, 2025

Introduction

GELNIQUE 3% (oxybutynin) gel is a groundbreaking treatment for overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and frequency. Developed by Antares Pharma and marketed by Watson Pharmaceuticals (now part of Teva Pharmaceutical Industries), this topical gel has shown significant efficacy and safety in clinical trials.

Clinical Trials Overview

Efficacy and Safety

The efficacy and safety of GELNIQUE 3% were evaluated in a randomized, double-blind, placebo-controlled, multicenter 12-week study, followed by an open-label safety extension. The study involved 626 patients, with 214 receiving 84 mg/day of oxybutynin, 210 receiving 56 mg/day, and 202 receiving a placebo. The primary efficacy endpoint was the change from baseline to week 12 in the number of urinary incontinence episodes (UIE) per week.

Patients treated with the 84 mg/day dose of GELNIQUE 3% experienced a statistically significant decrease in UIE per week compared to the placebo group. Additionally, significant improvements in daily urinary frequency and urinary void volume were observed[1][4].

Key Findings

• Reduction in Urinary Incontinence Episodes: Patients treated with GELNIQUE 3% (84 mg/day) showed a median reduction of 67% in UIE at week 12, compared to a 50% reduction in the placebo group[4].
• Early Treatment Effect: Significant reductions in incontinence episodes were seen as early as one week after starting the treatment[4].
• Secondary Endpoints: The treatment also resulted in significant reductions in daily urinary frequency and increases in urinary void volume compared to the placebo group[1][4].

Safety Profile

The safety profile of GELNIQUE 3% is favorable, with the most commonly reported adverse events being dry mouth (12.1%), application site erythema (3.7%), and application site rash (3.3%). The transdermal delivery mechanism reduces the formation of the N-desethyloxybutynin metabolite, which is associated with side effects like dry mouth and constipation seen with oral oxybutynin formulations[1][4].

Market Analysis

Market Size and Growth

Overactive bladder affects more than 33 million Americans, making it a significant market. The U.S. OAB treatment market exceeds $2.0 billion annually, providing a substantial opportunity for GELNIQUE 3% to capture market share[4].

Competitive Advantage

GELNIQUE 3% offers several competitive advantages:

• Convenient Dosing: The product is available in a metered pump dispenser, allowing for once-daily dosing and precise application[2][4].
• Low Side Effects: The transdermal delivery system minimizes systemic side effects common with oral OAB medications, such as dry mouth and constipation[2][4].
• Early Treatment Effect: Significant improvements in symptoms are observed as early as one week after starting treatment, which can enhance patient compliance and satisfaction[4].

Marketing and Distribution

Watson Pharmaceuticals, with its extensive experience and commitment to urology, has been instrumental in marketing and distributing GELNIQUE 3%. The partnership with Antares Pharma leverages Watson's well-established commercial team, enhancing the product's market reach and penetration[2][4].

Market Projections

Market Penetration

Given its efficacy, safety profile, and convenience, GELNIQUE 3% is expected to gain significant market penetration. The product's ability to provide early treatment effects and reduce common side effects associated with oral medications will likely attract a substantial patient base.

Revenue Growth

With the U.S. OAB treatment market valued at over $2.0 billion annually, GELNIQUE 3% is poised to capture a considerable share. The product's unique benefits and the growing demand for effective OAB treatments suggest strong revenue growth potential.

Future Developments

As more data from ongoing and future clinical trials become available, GELNIQUE 3% may expand its indications or improve its formulation, further enhancing its market position. Additionally, increasing awareness about OAB and the availability of effective treatments will drive market growth.

Expert Insights

Roger R. Dmochowski, M.D., professor of urologic surgery at Vanderbilt University Medical Center, highlighted the importance of GELNIQUE 3% for women with OAB, noting its strong efficacy and excellent tolerability[5].

Paul K. Wotton, Ph.D., President and CEO of Antares Pharma, emphasized the strategic partnership with Watson Pharmaceuticals, which has been crucial in bringing this innovative product to the market[2][4].

Key Takeaways

• Efficacy: GELNIQUE 3% significantly reduces urinary incontinence episodes, daily urinary frequency, and increases urinary void volume.
• Safety: The product has a favorable safety profile with minimal systemic side effects due to its transdermal delivery.
• Market Potential: With a large and growing OAB treatment market, GELNIQUE 3% is well-positioned for significant market penetration and revenue growth.
• Competitive Advantage: Convenient once-daily dosing, low side effects, and early treatment effects make GELNIQUE 3% a preferred option for patients.

FAQs

Q: What is GELNIQUE 3% used for?

A: GELNIQUE 3% is used for the treatment of overactive bladder symptoms, including urge urinary incontinence, urgency, and frequency.

Q: How is GELNIQUE 3% administered?

A: GELNIQUE 3% is administered topically using a metered pump dispenser, with three pumps (84 mg) applied once daily to clean, dry skin on the abdomen, upper arms/shoulders, or thighs.

Q: What are the common side effects of GELNIQUE 3%?

A: The most commonly reported side effects include dry mouth, application site erythema, and application site rash.

Q: Is GELNIQUE 3% suitable for all patients?

A: GELNIQUE 3% is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and should be used with caution in patients with certain other conditions.

Q: How does GELNIQUE 3% compare to oral OAB medications?

A: GELNIQUE 3% has a lower incidence of systemic side effects such as dry mouth and constipation due to its transdermal delivery mechanism.

Sources

1. FDA Label: GELNIQUE 3% (oxybutynin) gel 3% - accessdata.fda.gov
2. World Pharma Today: Antares, Watson Pharmaceuticals launch Gelnique 3% in US
3. Wiley Online Library: Transdermal patches: history, development and pharmacology
4. PR Newswire: Watson and Antares Announce the Introduction of Gelnique 3% for the Treatment of Overactive Bladder
5. BioSpace: Watson Pharmaceuticals, Inc. New Data Presented at American Urological Association’s Annual Conference Prove GELNIQUE(TM) Oxybutynin Chloride 10% Gel Effective in Treating OAB Symptoms