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DepoDur

Phase 1FDA approved 2004

Postoperative Pain | Small molecule | Pain |Pacira BioSciences, Inc.|Trials Updated: Aug 14, 2008

DepoDur development status

FDA approval May 18, 2004
Approval holderPacira Pharms Inc
ApplicationNDA021671
Highest phase Phase 1

DepoDur target and mechanism

ModalitySmall molecule

Also known as DepoDur (extended-release epidural morphine)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

DepoDur clinical trials

DepoDur · 1 trial · 1 indication

Phase 1 1
NCT00728832A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal SurgeryPostoperative Pain
COMPLETED39 Analytics
PHASE1COMPLETED
A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery
Postoperative PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the serum pharmacokinetic profile of a single 15-mg dose of DepoDur administered at the lower thoracic epidural space with or without a prior lidocaine-epinephrine test dose

Secondary Endpoints

efficacy and safety profiles
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORNo test dose + DepoDur + flush with 1 mL normal saline
2EXPERIMENTALTest dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline
3EXPERIMENTALTest dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline
4EXPERIMENTALTest dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline
5EXPERIMENTALTest dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline

Interventions

NameTypeDescription
DepoDur (extended-release epidural morphine)DRUGDepoDur with on demand boluses of IV fentanyl PCA
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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, ...

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Frequently asked questions about DepoDur

What is DepoDur?

DepoDur is an extended-release epidural morphine formulation developed by Pacira BioSciences, Inc. (ticker PCRX). It is a small molecule product studied for postoperative pain, designed to deliver morphine into the epidural space. It is also known as extended-release epidural morphine.

What is DepoDur used for?

DepoDur is used for postoperative pain, meaning pain following surgery. Its clinical development has focused on managing pain after procedures such as upper abdominal surgery. It is administered as an extended-release epidural morphine formulation rather than as a conventional immediate-release morphine product.

Who makes DepoDur?

DepoDur is developed by Pacira BioSciences, Inc., which trades under the ticker PCRX. Pacira is the company associated with the asset and its clinical development program in postoperative pain.

What phase is DepoDur in?

DepoDur is in Phase 1 development based on its recorded clinical program. It is an investigational product and is not described as approved. Its development activity in postoperative pain has centered on early-phase study rather than late-stage or registrational trials.

What clinical trials is DepoDur in?

DepoDur has been studied in the Phase 1 trial NCT00728832, titled A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery. That trial enrolled 39 participants, was randomized and active-controlled, and is now completed. No active trials are currently listed for DepoDur.

Is DepoDur the same as extended-release epidural morphine?

Yes. DepoDur is the brand name for extended-release epidural morphine, so searches for either term refer to the same product. It is a small molecule formulation developed by Pacira BioSciences, Inc. (PCRX) and studied for postoperative pain.