CLINICAL TRIALS PROFILE FOR NUCYNTA ER

All Clinical Trials for NUCYNTA ER

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.
NCT00986180 ↗	NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain	Completed	Grünenthal GmbH	Phase 3	2009-09-01	Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.

Clinical Trial Conditions for NUCYNTA ER

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for NUCYNTA ER

Trials by Country

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

Trials by US State

Trials by US State for NUCYNTA ER
Location	Trials
New York	2
Louisiana	2
Indiana	2
Florida	2
Ohio	2

Clinical Trial Progress for NUCYNTA ER

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for NUCYNTA ER

Sponsor Name

Sponsor Name for NUCYNTA ER
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 ER
Sponsor	Trials
Industry	9

NUCYNTA ER (tapentadol extended-release): Clinical-trial update, market analysis and projection

Last updated: May 1, 2026

What is NUCYNTA ER and how is it positioned in the opioid market?

NUCYNTA ER is tapentadol extended-release (ER), an oral opioid analgesic indicated for the management of chronic moderate to severe pain that requires daily, around-the-clock, long-term opioid treatment. It is marketed in the US by Depomed (legacy), now under Takeda’s stewardship for certain Depomed assets and branded pain portfolio items, and in other geographies through local partners (exact distributor varies by market).

Core product characteristics

• Drug: tapentadol ER
• Dosage form: oral ER tablets
• Indication (US label framing): chronic moderate to severe pain requiring daily, long-term opioid therapy
• Mechanism (as described in labeling): opioid receptor agonist and norepinephrine reuptake inhibition (dual mechanism; relevant for payer and prescriber profiling)

Competitive set (practical commercial comparison)

NUCYNTA ER sits inside the broader “extended-release opioids for chronic pain” competitive landscape. In commercial evaluations, it typically competes against:

• ER oxycodone (multiple brands and generics depending on jurisdiction)
• ER hydrocodone combinations and ER formulations
• ER morphine (brand and generic)
• ER fentanyl products (patches; different route but often compared in formulary and prescriber choices)

What is the clinical-trials update for NUCYNTA ER?

No current phase-advancement, pivotal registration trials can be confirmed from the provided dataset. NUCYNTA ER has an established label history, and the publicly tracked landscape is dominated by post-marketing safety studies, abuse-deterrence comparisons, and population-specific pharmacovigilance rather than new phase III readouts in recent cycles.

Last confirmed pivotal-era status (context)

• NUCYNTA ER is an established ER opioid product with prior clinical development that supported regulatory approval.
• Recent public-facing trial activity for tapentadol ER is generally late-stage observational or pharmacokinetic/pharmacodynamic work rather than new efficacy endpoints that materially change label scope.

What kinds of trials typically remain active (commercially relevant)

For ER opioids in mature markets, the recurring clinical-trial buckets are:

• Pharmacovigilance / post-marketing safety (real-world adverse event monitoring)
• Formulation and exposure work (bioequivalence, PK characterization in special populations)
• Abuse-deterrence or misuse-behavior evaluation (often observational or sponsor-sponsored studies with limited registrational intent)

Because a market projection depends on measurable label expansion (new indications, new dosing regimens, or route changes) and no registrational signal is confirmable from the available inputs, a conservative commercial stance is warranted: clinical development does not appear to be a near-term demand catalyst for NUCYNTA ER.

How does the market size and opioid policy regime shape NUCYNTA ER demand?

Macro demand: chronic pain opioids are contracting in branded share

Across major markets, ER opioid sales are pressured by:

• stricter prescribing rules and payer controls
• heightened scrutiny of long-term opioid therapy
• continued conversion toward non-opioid and multimodal pain strategies
• manufacturer behavior tied to risk management programs and REMS-like frameworks (US-centric dynamics)

Competitive pressure: generics compress margins and branded share

NUCYNTA ER competes against:

• generics of older ER opioids where available
• payer step-therapy pathways that favor lowest acquisition cost
• shifting formularies away from chronic opioid monotherapy

Branded ER growth, where it occurs, typically relies on:

• differentiated safety or tolerability perceptions
• payer contracting that maintains preferred formulary placement
• patient continuity after initiation

What do market benchmarks imply for NUCYNTA ER unit and revenue outlook?

With no confirmable new registrational trial activity and no confirmed label expansion in the accessible dataset, projection must follow the mature-product pattern: low growth or gradual decline driven by policy, generic substitution, and utilization management.

Projection framework (how the forecast is constructed)

A credible projection for an established ER opioid uses these drivers:

1. Total addressable chronic pain opioid demand trend (policy and substitution pressure)
2. Branded share retention (formulary placement and contracting outcomes)
3. Pricing dynamics (post-contract net price vs. list price erosion)
4. Competitor substitution (generic ER opioids and non-opioid growth)
5. Safety and utilization friction (prior authorization, duration limits, prescriber steering)

Given that the clinical-trial catalyst is not evident, the forecast is anchored to share retention rather than growth.

Revenue trajectory (scenario-based, directional)

• Base case: modest decline in revenue over the forecast horizon as branded ER share is eroded and payer controls tighten.
• Downside case: faster decline if formulary restrictions expand or if prescriber behavior shifts more aggressively to non-opioid pathways.
• Upside case: stabilization if NUCYNTA ER maintains preferred status in key managed-care contracts and if tolerability positioning sustains patient retention after switch.

Because no quantified sales history, current brand revenues, or contract coverage inputs are provided here, the forecast is constrained to directional outcomes rather than numeric year-by-year revenue.

What commercial signals should be monitored to validate the projection?

Even without a registrational pipeline catalyst, near-term outcomes track to execution and access.

Formulary and access indicators

• Preferred vs non-preferred placement in large PBMs and state Medicaid programs
• Step therapy uptake: proportion of scripts requiring prior authorization
• Duration limits and dose escalation controls
• Payer edits tied to risk criteria and concurrent benzodiazepine or comorbidity flags

Clinical utilization indicators

• Persistence on therapy after initiation (patient retention drives steady-state volume)
• Switch rates to alternative ER opioids or non-opioid regimens
• Adverse event signals that trigger formulary removals or restrictions

What is the likely impact of generic competition on NUCYNTA ER?

In mature ER opioid classes, generic entry and incremental price competition typically produce:

• lower brand net price
• reduced initiation volume due to access restrictions
• reliance on continuity-of-care cohorts

For NUCYNTA ER, the commercial implication is that growth requires either:

• sustained differentiation in access (preferred contracts), or
• strong tolerability perception translating into persistence and reduced discontinuation

Without a confirmable label-expansion trial signal, brand momentum is unlikely to overcome generic-driven pressure.

Key Takeaways

• NUCYNTA ER is a mature, established ER opioid for chronic moderate to severe pain requiring continuous long-term opioid therapy.
• No confirmable registrational clinical trial catalyst is available from the supplied dataset; recent activity appears consistent with post-marketing and non-pivotal studies rather than label-expanding phase advancement.
• Market outlook is constrained by policy and generic compression: the most likely path is stabilization at best or gradual revenue decline as formulary restrictions and non-opioid substitution continue.
• Forecast validation hinges on access: preferred formulary placement, prior authorization behavior, and patient persistence are the primary levers that determine whether branded share holds.

FAQs

1) Does NUCYNTA ER have new trial data that could expand its label soon?
No confirmable registrational label-expansion readouts are supported by the available input set.

2) What most affects near-term NUCYNTA ER sales: clinical development or payer access?
Payer access and formulary placement are the dominant near-term drivers for a mature branded ER opioid in a tightening policy environment.

3) How does generic competition typically change branded ER opioid revenue?
It usually compresses net pricing, reduces initiation volume through step edits, and shifts growth to continuity-of-care cohorts.

4) What safety or compliance factors can change formulary outcomes?
Adverse event patterns that trigger restrictions, plus utilization controls such as prior authorization and therapy duration edits.

5) What should investors watch to judge whether the base-case decline holds?
Preferred contract retention, changes in step-therapy and prior-authorization rates, and therapy persistence after initiation.

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References

1. FDA. NUCYNTA ER (tapentadol extended-release) Prescribing Information (accessed via FDA label repository).
2. ClinicalTrials.gov. NUCYNTA ER and tapentadol extended-release study records (accessed via database query).
3. FDA. Opioid-related safety communications and regulatory frameworks impacting chronic opioid prescribing (accessed via FDA opioid safety resources).