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CLINICAL TRIALS PROFILE FOR NUCYNTA

All Clinical Trials for NUCYNTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00472303 ↗	A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2007-07-01	The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR). *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.
NCT00472303 ↗	A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine	Completed	Grünenthal GmbH	Phase 3	2007-07-01	The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR). *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.
NCT00505414 ↗	A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine	Terminated	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2007-06-01	The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
NCT00505414 ↗	A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine	Terminated	Grünenthal GmbH	Phase 3	2007-06-01	The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
NCT00982280 ↗	Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability.	Terminated	Grünenthal GmbH	Phase 3	2009-09-01	The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride PR treatment during defined periods of evaluation.
NCT00983073 ↗	Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic	Completed	Grünenthal GmbH	Phase 3	2009-09-01	The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

Clinical Trial Conditions for NUCYNTA

Condition Name

Condition Name for NUCYNTA
Intervention	Trials
Pain	3
Chronic Pain	2
Low Back Pain	2
Osteoarthritis	2

Condition MeSH

Condition MeSH for NUCYNTA
Intervention	Trials
Cancer Pain	2
Low Back Pain	2
Back Pain	2
Osteoarthritis	2

Clinical Trial Locations for NUCYNTA

Trials by Country

Trials by Country for NUCYNTA
Location	Trials
United States	33
Argentina	4
Germany	4
Spain	4
Poland	3

Trials by US State

Trials by US State for NUCYNTA
Location	Trials
Ohio	2
North Carolina	2
New York	2
Louisiana	2
Indiana	2

Clinical Trial Progress for NUCYNTA

Clinical Trial Phase

Clinical Trial Phase for NUCYNTA
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5

Clinical Trial Status

Clinical Trial Status for NUCYNTA
Clinical Trial Phase	Trials
Completed	4
Terminated	2

Clinical Trial Sponsors for NUCYNTA

Sponsor Name

Sponsor Name for NUCYNTA
Sponsor	Trials
Grünenthal GmbH	6
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2
Ortho-McNeil Janssen Scientific Affairs, LLC	1

Sponsor Type

Sponsor Type for NUCYNTA
Sponsor	Trials
Industry	9

NUCYNTA Market Analysis and Financial Projection

NUCYNTA: Clinical Trials, Market Analysis, and Projections

Introduction to NUCYNTA

NUCYNTA, known generically as tapentadol, is an opioid medication designed to manage acute and chronic pain. It is available in two formulations: NUCYNTA for short-term pain management and NUCYNTA ER (extended-release) for the management of severe and persistent pain in adults[2].

Clinical Trials and Efficacy

Phase 3 Clinical Trials for Diabetic Peripheral Neuropathy (DPN)

Significant clinical trials have demonstrated the efficacy of NUCYNTA ER in managing chronic pain associated with diabetic peripheral neuropathy (DPN). A Phase 3 randomized-withdrawal, placebo-controlled study presented at the 31st Annual Scientific Meeting of the American Pain Society showed that NUCYNTA ER was significantly more effective than placebo in reducing pain intensity in adults with moderate to severe, chronic painful DPN.

• The study involved an open-label phase with a 3-week titration period to determine the optimal dose for each patient, followed by a 12-week double-blind maintenance phase.
• The primary efficacy endpoint was the mean change in average pain intensity from baseline to the last week of the maintenance phase, measured using an 11-point pain rating scale.
• Results indicated that pain increased in the placebo group, while the tapentadol ER group maintained efficacy, with a least-squares mean difference of -0.95 favoring tapentadol ER (p < 0.001)[1][4].

Safety and Tolerability

Safety assessments were performed throughout the study, monitoring treatment-emergent adverse events (TEAEs). The data from these studies also provided evidence of the long-term safety and tolerability of NUCYNTA ER[4].

Market Analysis

Market Position and Exclusivity

As of 2024, NUCYNTA and NUCYNTA ER have been granted pediatric exclusivity by the U.S. Food and Drug Administration (FDA), extending their brand exclusivity. This extension delays the entry of generic versions until December 27, 2025, for NUCYNTA ER and January 3, 2027, for NUCYNTA[2][5].

Current Pricing and Cost

The current prices of NUCYNTA are substantial, with recent increases reflecting broader trends in the pharmaceutical industry. For example, a supply of 100 tablets of NUCYNTA 50 mg can cost around $1,124, while 100 tablets of NUCYNTA 75 mg and 100 mg cost approximately $1,311 and $1,745, respectively[2].

Impact of Generic Alternatives

The entry of generic versions of NUCYNTA is expected to significantly reduce the market share and revenue of the brand-name medication. Generic medications typically cost 80-85% less than their brand-name equivalents, which could lead to substantial cost savings for patients and a shift in market dynamics[2].

Competitive Landscape

The opioid market is highly competitive, with various branded and generic options available. NUCYNTA's unique formulation and extended exclusivity period give it a competitive edge. However, the market will become more competitive as generic versions enter, potentially leading to increased competition among manufacturers and lower prices overall[2].

Market Projections

Generic Entry and Price Reduction

After the exclusivity period ends in 2025 and 2027 for NUCYNTA ER and NUCYNTA, respectively, generic versions are expected to enter the market. This will likely lead to a significant reduction in prices, making the medication more affordable for patients[2].

Revenue and Sales Forecasts

GlobalData provides detailed forecasts and valuation models for pharmaceutical assets, including NUCYNTA. Despite the impending generic competition, NUCYNTA continues to be a valuable asset, with forecasts indicating ongoing revenue and sales, albeit at a reduced level once generics are available[2].

Patient Assistance and Discount Programs

To mitigate the high costs of NUCYNTA, various patient assistance programs and discount cards are available. For instance, the Drugs.com Discount Card can save patients up to 80% on prescription medications, including NUCYNTA. These programs help make the medication more accessible to patients who might otherwise struggle with the costs[2].

Future Outlook

Neuropathic Pain Market Growth

The global neuropathic pain market, which includes treatments like NUCYNTA, is expected to grow significantly. By 2034, the market is projected to reach USD 8.1 billion, driven by advancements in pain management solutions and increasing demand for effective treatments[3].

Regulatory Changes and Market Dynamics

Industry experts emphasize the importance of monitoring regulatory changes and market dynamics. The entry of generic versions, changes in exclusivity periods, and advancements in pain management technologies will continue to shape the market for NUCYNTA and similar medications[2].

Key Takeaways

• Clinical Efficacy: NUCYNTA ER has demonstrated significant efficacy in managing chronic pain associated with DPN in clinical trials.
• Market Exclusivity: NUCYNTA and NUCYNTA ER have extended brand exclusivity due to FDA grants for pediatric use.
• High Current Prices: The current prices of NUCYNTA are substantial, with recent increases reflecting broader industry trends.
• Generic Impact: The entry of generic versions is expected to reduce market share and revenue for the brand-name medication and lower prices.
• Patient Assistance: Various patient assistance programs and discount cards are available to help mitigate the high costs of NUCYNTA.
• Market Growth: The neuropathic pain market is expected to grow, driven by advancements in pain management solutions.

FAQs

What is NUCYNTA used for?

NUCYNTA is used to manage acute and chronic pain. The extended-release formulation, NUCYNTA ER, is specifically designed for the management of severe and persistent pain in adults, including neuropathic pain associated with diabetic peripheral neuropathy (DPN)[2].

When are generic versions of NUCYNTA expected to enter the market?

Generic versions of NUCYNTA ER are expected to enter the market after December 27, 2025, and generic versions of NUCYNTA after January 3, 2027, following the end of their brand exclusivity periods[2][5].

How much does NUCYNTA cost?

The cost of NUCYNTA is substantial, with a supply of 100 tablets of NUCYNTA 50 mg costing around $1,124, and higher doses costing up to $1,745 for 100 tablets[2].

What are the potential cost savings with generic versions of NUCYNTA?

Generic medications typically cost 80-85% less than their brand-name equivalents, which could lead to significant cost savings for patients once generics are available[2].

Are there patient assistance programs for NUCYNTA?

Yes, various patient assistance programs and discount cards are available to help mitigate the high costs of NUCYNTA. For example, the Drugs.com Discount Card can save patients up to 80% on prescription medications, including NUCYNTA[2].

Sources

1. Janssen Pharmaceuticals, Inc. - Phase 3 Data Show NUCYNTA® ER (tapentadol) Extended-Release Tablets Provide Pain Management for Patients with Diabetic Peripheral Neuropathy (DPN)[1].
2. DrugPatentWatch - Pharmaceutical drug prices and trends for NUCYNTA[2].
3. Biospace - Neuropathic Pain Market Size to Reach USD 8.1 Billion by 2034[3].
4. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. - Supplemental New Drug Application Submitted To FDA For NUCYNTA® ER (tapentadol) Extended-Release Tablets For Diabetic Peripheral Neuropathic Pain[4].
5. Biospace - Collegium Obtains Six Month Extension of U.S. Pediatric Exclusivity for Nucynta Franchise[5].