Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DepoDur · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | No test dose + DepoDur + flush with 1 mL normal saline |
| 2 | EXPERIMENTAL | Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline |
| 3 | EXPERIMENTAL | Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline |
| 4 | EXPERIMENTAL | Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline |
| 5 | EXPERIMENTAL | Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline |
| Name | Type | Description |
|---|---|---|
| DepoDur (extended-release epidural morphine) | DRUG | DepoDur with on demand boluses of IV fentanyl PCA |
Inclusion Criteria: * Males and females ≥ 18 years of age at Screening * Negative pregnancy test in females of childbearing potential * Scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia * American Society of Anesthesiology (ASA) Physical Class 1, 2, ...
DepoDur is an investigational small molecule being developed for postoperative pain. It is an extended-release epidural morphine formulation studied in patients undergoing upper abdominal surgery. The drug is designed to provide pain relief following surgical procedures, with a completed Phase 1 pharmacokinetic study evaluating its effects.
DepoDur is being developed by Pacira BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PCRX. The company is responsible for the clinical development of this extended-release epidural morphine product for postoperative pain management.
DepoDur is in Phase 1 clinical development. A single Phase 1 study has been completed, which focused on the pharmacokinetics of extended-release epidural morphine in upper abdominal surgery patients. The drug remains investigational and has not been approved by regulatory authorities.
DepoDur has one completed clinical trial registered as NCT00728832, titled "A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery." This Phase 1 study enrolled 39 participants with postoperative pain and was actively controlled, though it was not double-blinded.
DepoDur is an extended-release formulation of morphine, an opioid analgesic. It is administered epidurally to provide prolonged pain relief after surgery. The extended-release mechanism allows for sustained delivery of morphine, which acts on opioid receptors in the central nervous system to reduce pain perception.