Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oxymorphone IR · 2 trials · 2 indications
Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet
Percentages are based on the number of subjects in each treatment group.
| Arm | Type | Description |
|---|---|---|
| Oxymorphone IR | EXPERIMENTAL | Open-Label, 2 part ascending-dose multicenter study |
| Oxymorphone | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Oxymorphone IR | DRUG | Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs |
Inclusion Criteria: * Male or female \> 12 to 17 years of age, inclusive * Weigh at least 50 kg * Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia * Are expected to be hospitalized for the duration of the study Exclusion C...
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Oxymorphone IR is an immediate-release small molecule opioid being studied for the treatment of postoperative pain and post-operative pain. It is currently in Phase 3 clinical development and is not yet approved by the FDA.
Oxymorphone IR is being developed by BrainsWay Ltd., a company publicly traded under the ticker BWAY. The drug is in Phase 3 clinical trials for postoperative pain.
Oxymorphone IR is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials have been completed for postoperative pain.
Oxymorphone IR has been studied in two completed Phase 3 trials: NCT00801398, an open-label safety study in pediatric subjects with postoperative pain, and NCT00904085, a post-operative efficacy and safety study in adults.
Oxymorphone IR is an immediate-release formulation of oxymorphone, an opioid analgesic. The drug is being studied for acute postoperative pain, with trials including a pediatric safety study and an adult efficacy study.