Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
oxymorphone · 4 trials · 6 indications
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain).
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID was calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain)
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID is calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.
Rescue Medication Use in Multiple Dose Phase
| Arm | Type | Description |
|---|---|---|
| CII Drug | EXPERIMENTAL | Open Label |
| Single Arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| oxymorphone HCl | DRUG | Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone |
| Oxymorphone Extended Release | DRUG | - |
Inclusion Criteria: 1. Males or females between 2 to ≤12 years of age. Females of child-bearing potential must be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, a...
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Oxymorphone is used for post operative pain. It is being studied as an immediate release oral liquid formulation for post surgical pediatric subjects. The drug is in Phase 3 clinical development and is considered investigational for this use.
Oxymorphone is being developed by BrainsWay Ltd. (NASDAQ: BWAY). The company is conducting clinical trials to evaluate the drug for the treatment of post operative pain.
Oxymorphone is in Phase 3 clinical development. It is an investigational drug and has not been approved for the treatment of post operative pain. One Phase 3 trial has been completed.
Oxymorphone has one completed clinical trial, NCT01210352, titled "Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects." The trial enrolled 61 participants in the United States.
Oxymorphone is not FDA approved for the indication of post operative pain. It is an investigational drug currently in Phase 3 clinical development. The completed trial NCT01210352 evaluated its effectiveness, safety, and tolerability in pediatric subjects.