NUCYNTA ER (tapentadol hydrochloride)
NUCYNTA ER (tapentadol) is an opioid agonist indicated for the management of severe and persistent pain in adults, as well as neuropathic pain associated with diabetic peripheral neuropathy (DPN), that requires an opioid analgesic and cannot be adequately treated with alternative options, including immediate-release opioids. Because of the risks of addiction, abuse, misuse, overdose, and death, NUCYNTA ER is reserved for patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate. It is intended for continuous, around-the-clock pain management and is not indicated for use as an as-needed (prn) analgesic.
How NUCYNTA ER Works
Tapentadol is a centrally-acting synthetic analgesic. While its exact mechanism of action in humans is unknown, preclinical studies demonstrate that it acts as a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Data from animal models suggest that its analgesic activity is derived from both of these properties, although the clinical relevance of these preclinical findings is unclear.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-08-25
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
NUCYNTA ER Approval History
What NUCYNTA ER Treats
3 indicationsNUCYNTA ER is approved for 3 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Neuropathic Pain
- Diabetic Neuropathy
NUCYNTA ER Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NUCYNTA ER WARNING: SERIOUS LIFE-THREATENING RISKS FROM USE OF NUCYNTA ER See FULL PRESCRIBING INFORMATION for complete boxed warning . NUCYNTA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and reassess regularly for development of these behaviors or conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially upon...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NUCYNTA ER WARNING: SERIOUS LIFE-THREATENING RISKS FROM USE OF NUCYNTA ER See FULL PRESCRIBING INFORMATION for complete boxed warning . NUCYNTA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and reassess regularly for development of these behaviors or conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially upon initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of NUCYNTA ER are essential. Instruct patients to swallow NUCYNTA ER tablets whole to avoid exposure to a potentially fatal dose of tapentadol. ( 2.1 , 5.2 ) Accidental ingestion of NUCYNTA ER, especially in children, can result in fatal overdose of tapentadol. ( 5.2 ) Instruct patients not to consume alcohol or any products containing alcohol while taking NUCYNTA ER because co-ingestion can result in fatal plasma tapentadol levels. ( 5.3 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.4 ) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription. ( 5.5 ) Addiction, Abuse, and Misuse Because the use of NUCYNTA ER exposes patients and other users to the risks of op
NUCYNTA ER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NUCYNTA ER
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05999890 | KIMS/IEC/A035/D/2021 | Ph 4 | completed | Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol |
| NCT01631513 | CR100757 R331333PAI4005 | Ph 4 | withdrawn | An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR) |
| NCT01124604 results posted | CR016999 JNS024ER-JPN-N21 | Ph 2 | completed | An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NUCYNTA ER FDA Label Details
Indications & Usage
FDA Label (PDF)NUCYNTA ER is indicated for the treatment of Pain; Neuropathic Pain; Diabetic Neuropathy.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NUCYNTA ER WARNING: SERIOUS LIFE-THREATENING RISKS FROM USE OF NUCYNTA ER See FULL PRESCRIBING INFORMATION for complete boxed warning . NUCYNTA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Ass...
NUCYNTA ER Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for NUCYNTA ER
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 125 active patents
Trial Analysis
- • 11 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment