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CLINICAL TRIALS PROFILE FOR EXPAREL

505(b)(2) Clinical Trials for Exparel

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.

All Clinical Trials for Exparel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00485433 ↗	Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair	Completed	Pacira Pharmaceuticals, Inc	Phase 2	2007-06-01	The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.
NCT00485693 ↗	Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty	Completed	Pacira Pharmaceuticals, Inc	Phase 2	2007-06-01	Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty
NCT00529126 ↗	Phase 2 Dose-Ranging Study of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy	Completed	Pacira Pharmaceuticals, Inc	Phase 2	2007-09-01	Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.
NCT00813111 ↗	Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation	Terminated	Pacira Pharmaceuticals, Inc	Phase 3	2008-11-01	The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
NCT00890682 ↗	Study of Postoperative Analgesia in Bunionectomy	Completed	Pacira Pharmaceuticals, Inc	Phase 3	2009-04-01	After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.
NCT00890721 ↗	Study of Pain Control in Hemorrhoidectomy	Completed	Pacira Pharmaceuticals, Inc	Phase 3	2009-05-01	Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.
NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.

Clinical Trial Conditions for Exparel

Condition Name

Condition Name for Exparel
Intervention	Trials
Pain, Postoperative	41
Pain	31
Postoperative Pain	26
Opioid Use	12

Condition MeSH

Condition MeSH for Exparel
Intervention	Trials
Pain, Postoperative	94
Osteoarthritis	17
Rotator Cuff Injuries	11
Osteoarthritis, Knee	10

Clinical Trial Locations for Exparel

Trials by Country

Trials by Country for Exparel
Location	Trials
United States	362
Denmark	4
Belgium	3
China	1
Taiwan	1

Trials by US State

Trials by US State for Exparel
Location	Trials
Ohio	34
Texas	34
New York	31
California	27
Florida	24

Clinical Trial Progress for Exparel

Clinical Trial Phase

Clinical Trial Phase for Exparel
Clinical Trial Phase	Trials
Phase 4	154
Phase 3	34
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Exparel
Clinical Trial Phase	Trials
Completed	110
Recruiting	47
Terminated	36

Clinical Trial Sponsors for Exparel

Sponsor Name

Sponsor Name for Exparel
Sponsor	Trials
Pacira Pharmaceuticals, Inc	61
Mayo Clinic	12
The Cleveland Clinic	7

Sponsor Type

Sponsor Type for Exparel
Sponsor	Trials
Other	260
Industry	67
U.S. Fed	7