XTAMPZA ER (oxycodone)
XTAMPZA ER treats severe and persistent pain in patients who require daily, around-the-clock opioid therapy. It is used when alternative treatments, such as immediate-release opioids, are ineffective, not tolerated, or otherwise inadequate for pain management. This medication is intended for continuous use and is not used for as-needed pain relief.
How XTAMPZA ER Works
This medication works by binding to specific opioid receptors in the brain and spinal cord, primarily targeting the mu receptor. While the exact process is not fully understood, this binding action triggers the drug's analgesic effects to help manage pain. As a full opioid agonist, it provides pain relief that can be adjusted based on the patient's needs without a ceiling effect.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-04-26
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
XTAMPZA ER Approval History
What XTAMPZA ER Treats
1 indicationsXTAMPZA ER is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
XTAMPZA ER Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER See full prescribing information for complete boxed warning . XTAMPZA 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 these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur especially during initiati...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER See full prescribing information for complete boxed warning . XTAMPZA 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 these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of XTAMPZA ER are essential. ( 5.2 ) Accidental ingestion of XTAMPZA ER, especially by children, can result in fatal overdose of oxycodone. ( 5.2 ) 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 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 ) Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone from XTAMPZA ER. ( 5.6 , 12.3 ) Addiction, Abuse, and Misuse Because the use of XTAMPZA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly
XTAMPZA ER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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 XTAMPZA ER
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
119 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07223450 results posted | 2024-515461-34-00 2024-515461-34-00 | Ph 1 | completed | A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling |
| NCT03823534 | 28927 | Ph 3 | recruiting | Post-Op Pain Control for Prophylactic Intramedullary Nailing. |
| NCT03574792 results posted | I 61117 NCI-2018-01055, I 61117 | Ph 2 | completed | Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy |
| NCT03759028 | IRB# 18-001158 | Ph 4 | recruiting | Supracondylar Post-Operative Pain Study |
| NCT07435077 EASE | IRB00140421 | Ph 4 | not yet recruiting | Examining Analgesic Synergy and Efficacy in Trauma Care |
| NCT07153003 | 25-002295 | Ph 4 | enrolling by invitation | Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty |
| NCT05597878 | IRB00091354 WFBCCC 01122 | Ph 2, Ph 3 | suspended | Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy |
| NCT06232577 | 2023-0818 NCI-2024-00632 | Ph 2 | active not recruiting | 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial |
| NCT03978767 PANDA | 201901202 | Ph 2 | completed | Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial |
| NCT03888144 SKOPE results posted | 17-872 | Ph 4 | completed | Study of Ketorolac Versus Opioid for Pain After Endoscopy |
| NCT06505187 | 2023-1527 A539770, Protocol Version 7/5/24 | Ph 2 | recruiting | Celecoxib for ENT Pain Management |
| NCT01536301 | LOCAL/2011/PC-02 2011-004140-22 | Ph 4 | completed | Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery |
| NCT06434233 | IRB00308549 | Ph 4 | recruiting | Opioid Use After Laparoscopic Salpingectomy |
| NCT05842044 No-PAIN | 20220783 | Ph 2 | recruiting | NSAID Use After Robotic Partial Nephrectomy |
| NCT06186141 POPCORN | 91523 | Ph 4 | recruiting | Nausea and Vomiting in Postoperative Paediatric Patients With Patient-Controlled Analgesia (PCA): Morphine vs Oxycodone |
| NCT03893175 | 832417 | Ph 1 | completed | Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction |
| NCT05076110 | 21-003441 | Ph 4 | recruiting | Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures |
| NCT05965492 | 20230423 | Ph 3 | withdrawn | Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery |
| NCT06757140 | 97946 R01DA016718 | Ph 1, Ph 2 | recruiting | Opioid Drug Interaction Study |
| NCT05447286 | 2000033008 UG3DA050322, NYX-783-1009 | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics of NYX-783 and Oxycodone DDI Study |
| NCT06864312 | ANKLE 2023 | Ph 4 | completed | Rebound Pain Following Regional Anaesthesia for Ankle Fracture Surgery |
| NCT05974501 results posted | 20230147 | Ph 4 | completed | Pre vs Post Block in Total Knee Arthroplasty (TKA) |
| NCT03679949 | 7647 | Ph 1 | completed | Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia |
| NCT06669650 | 5226 CORNET Award | Ph 4 | active not recruiting | Personalized Post-Operative Pain Management |
| NCT05567354 | PF614-103 | Ph 1 | completed | A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103) |
| NCT03859024 results posted | IRB-300002992 | Ph 4 | completed | Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty |
| NCT04791761 results posted | STUDY19040036 (Part 2) | Ph 1, Ph 2 | terminated | Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy |
| NCT04015908 results posted | 121505 | Ph 4 | completed | A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery |
| NCT04396587 | NAESHO | Ph 4 | completed | Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone |
| NCT05363436 | 19D.688Panc | Ph 4 | suspended | Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed |
| NCT03789318 results posted | CA-PS-204 | Ph 2 | completed | Study in Subjects Undergoing Complete Abdominoplasty |
| NCT04122443 results posted | 2019-10592 | Ph 4 | completed | Acetaminophen (APAP) +/- Oxycodone |
| NCT06041425 | 2023-SR-093 | Ph 4 | completed | The Effects of Oxycodone Versus Sufentanil on Pain and Inflammatory Response After TACE |
| NCT02892591 | 14-1909 | Ph 3 | completed | Cannabis Versus Oxycodone for Pain Relief |
| NCT03415555 | KE-0254/26/2018 | Ph 4 | completed | Postoperative Analgesia After Minithoracotomy |
| NCT04285853 results posted | IRB00116728 | Ph 4 | completed | Are Opioids Needed After ACL Reconstruction |
| NCT04246697 | 00025711 | Ph 4 | completed | Multimodal Pain Study in Free Flap Patients |
| NCT04429022 RA-TLH results posted | STUDY00004549 | Ph 3 | completed | Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy |
| NCT05327777 results posted | 19D.688 | Ph 4 | completed | Toward Zero Prescribed Opioids for Outpatient General Surgery |
| NCT03253133 NIPOX | ICM-URC2015/34 | Ph 1 | completed | Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC |
| NCT04223609 results posted | 19-004883 | Ph 1, Ph 2 | completed | Non-intrusive Detection of Temporary Neurologic Impairment By Opioids |
| NCT01959204 results posted | 2012O004 | Ph 4 | completed | Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent Subjects |
| NCT05468671 | IRB-2020-406 | Ph 4 | completed | Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy |
| NCT03906721 | 2017P001673 | Ph 2 | completed | Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury |
| NCT03088826 results posted | 2017-01-05 | Ph 2 | completed | Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) |
| NCT00820027 results posted | 0663-098 2009_502 | Ph 3 | completed | Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098) |
| NCT02728648 | 20162-2143 | Ph 4 | completed | Population Pharmacokinetic-Pharmacodynamic Study of Intravenous Oxycodone in Malaysian Population |
| NCT02604446 | TPO-150 2015-000295-94 | Ph 3 | completed | Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo |
| NCT03618823 results posted | STUDY19040036 (Part 1) | Ph 1, Ph 2 | terminated | Non-opioids for Analgesia After Adenotonsillectomy in Children |
| NCT04726878 | KE-0254/92/2018 | Ph 4 | completed | ESP in Breast Surgery Due to Cancer |
Showing 50 of 119 trials
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.
XTAMPZA ER FDA Label Details
Indications & Usage
FDA Label (PDF)XTAMPZA ER is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER See full prescribing information for complete boxed warning . XTAMPZA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death....
XTAMPZA ER Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for XTAMPZA ER
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 200 active patents
Trial Analysis
- • 146 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