ROXYBOND
ROXYBOND is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ROXYBOND is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve op...
Details
- Status
- Prescription
- First Approved
- 2017-04-20
- 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
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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
ProIndications & Usage
FDA Label (PDF)ROXYBOND is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ROXYBOND is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ROXYBOND, for use in patients for whom alternative treatment options are ineffe...
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.