Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
oxymorphone · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz) |
| 2 | ACTIVE_COMPARATOR | Opana 40 mg extended release tablets |
| Name | Type | Description |
|---|---|---|
| oxymorphone hydrochloride | DRUG | - |
| Opana | DRUG | - |
| oxymorphone | DRUG | Tablets |
Inclusion Criteria: * No clinically significant abnormal findings on physical exam, nonmedical history or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C * Treatment for drug or alcohol abuse * Allergy to opiates
Oxymorphone is a small molecule drug being developed for the treatment of pain. It is currently in Phase 1 clinical development, with studies evaluating the bioavailability of extended release tablets under fed and fasted conditions.
Oxymorphone is being developed by Novartis AG, which is listed on the stock exchange under the ticker NVS. The company is conducting clinical trials to evaluate the drug's bioavailability in healthy volunteers.
Oxymorphone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with no active trials currently ongoing.
Oxymorphone has been studied in two completed Phase 1 clinical trials: NCT00857142, which evaluated the bioavailability of oxymorphone hydrochloride 40 mg extended release tablets under fed conditions, and NCT00857428, which evaluated the same under fasted conditions. Both trials enrolled healthy volunteers aged 18 years and older.
Oxymorphone is the active pharmaceutical ingredient, and oxymorphone hydrochloride is the salt form used in the extended release tablets being studied. The clinical trials evaluate oxymorphone hydrochloride 40 mg extended release tablets.