NUCYNTA ER
Details
- Status
- Prescription
- First Approved
- 2011-08-25
- 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
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Active Pipeline
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Key Completed Trials
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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
ProIndications & Usage
FDA Label (PDF)NUCYNTA ER (tapentadol) is indicated for the management of: Severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. NUCYNTA ER is an opioid agonist indicated for the management of: severe and persistent pain in adults that requires an opioid analg...
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 (125 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.