ROXYBOND (oxycodone hydrochloride)
ROXYBOND is an opioid medication used for patients experiencing severe pain that cannot be managed with other treatment options. It helps patients who have not found relief from alternative therapies or who cannot tolerate other types of pain management. Because of the serious risks associated with opioids, such as addiction and overdose, this drug is reserved for cases where other treatments are inadequate to provide sufficient pain control.
How ROXYBOND Works
This drug works by acting as a full opioid agonist that primarily targets mu-opioid receptors in the central nervous system. When it binds to these receptors in the brain and spinal cord, it mimics the activity of natural opioid-like compounds to produce its pain-relieving effects. There is no ceiling effect for its analgesic action, though the dosage is often limited by potential side effects like respiratory depression.
Details
- Status
- Prescription
- First Approved
- 2017-04-20
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
ROXYBOND Approval History
What ROXYBOND Treats
1 indicationsROXYBOND is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
ROXYBOND Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXYBOND WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXYBOND See full prescribing information for complete boxed warning. ROXYBOND exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess 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 follo...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXYBOND WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXYBOND See full prescribing information for complete boxed warning. ROXYBOND exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess 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 ROXYBOND are essential. ( 5.2 ) Accidental ingestion of ROXYBOND, especially by children, can result in a 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 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 ) Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone. ( 5.6 , 7 , 12.3 ) Addiction, Abuse, and Misuse Because the use of ROXYBOND 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 for the development o
ROXYBOND 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 ROXYBOND
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02536209 | MT-8554-E03 | Ph 1 | completed | A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects |
| NCT04240626 | 1452523 | Ph 4 | active not recruiting | Multimodal Analgesia Effect on Post Surgical Patient |
| NCT03685188 | WCH2018086 | Ph 4 | enrolling by invitation | Oxycodone and Sufentanil for Analgesia in Hip Surgery |
| NCT06444997 | B2024-161R | Ph 4 | not yet recruiting | Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients |
| NCT02531906 | I 262314 NCI-2015-01338, I 262314 | Ph 1 | completed | Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation |
| NCT03586934 | ORA 17071004 | Ph 3 | withdrawn | Multimodal Analgesia in Shoulder Arthroplasty |
| NCT01643772 results posted | OXYC09-CN-102 | Ph 1 | completed | OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study |
| NCT02660229 SWITCH results posted | OXI15-KR-401 | Ph 4 | completed | An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion. |
| NCT03254459 results posted | INS005-17-111 | Ph 2 | completed | Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain |
| NCT00626600 | OXI3001 2007-005101-21 | Ph 3 | terminated | A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion |
| NCT00801788 | OC-EG-001 | Ph 1 | completed | Single Dose Pharmacokinetics of Egalet® Oxycodone |
| NCT01530542 | K234-10-1001 B4501006 | Ph 1 | completed | A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers |
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.
ROXYBOND FDA Label Details
Indications & Usage
FDA Label (PDF)ROXYBOND is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXYBOND WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXYBOND See full prescribing information for complete boxed warning. ROXYBOND exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess...
ROXYBOND Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for ROXYBOND
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 32 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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.