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.

Clinical Trial Conditions for Exparel

Condition Name

Condition Name for Exparel
Intervention	Trials
Pain, Postoperative	42
Pain	31
Postoperative Pain	27
Opioid Use	14

Condition MeSH

Condition MeSH for Exparel
Intervention	Trials
Pain, Postoperative	97
Osteoarthritis	17
Rotator Cuff Injuries	12
Fractures, Bone	10

Clinical Trial Locations for Exparel

Trials by Country

Trials by Country for Exparel
Location	Trials
United States	369
Denmark	4
Belgium	3
United Kingdom	1
Hong Kong	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	158
Phase 3	36
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Exparel
Clinical Trial Phase	Trials
Completed	110
Recruiting	52
Terminated	36

Clinical Trial Sponsors for Exparel

Sponsor Name

Sponsor Name for Exparel
Sponsor	Trials
Pacira Pharmaceuticals, Inc	62
Mayo Clinic	13
The Cleveland Clinic	7

Sponsor Type

Sponsor Type for Exparel
Sponsor	Trials
Other	268
Industry	68
U.S. Fed	7

EXPAREL: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to EXPAREL

EXPAREL, developed by Pacira BioSciences, is a groundbreaking bupivacaine liposome injectable suspension designed for postsurgical pain management. It utilizes Pacira's proprietary multivesicular liposomal drug delivery technology, which releases bupivacaine over an extended period, providing long-lasting pain relief.

Clinical Trials Overview

Phase 3 Studies in Total Knee Arthroplasty

Recent Phase 3 studies have demonstrated the efficacy and safety of EXPAREL as a single-dose femoral nerve block in the adductor canal for patients undergoing total knee arthroplasty. These studies showed statistically significant reductions in cumulative pain scores and postsurgical opioid consumption through 96 hours compared to bupivacaine HCl[1].

Phase 3 Studies in Bunionectomy

A pivotal Phase 3 study published in 2024 highlighted the effectiveness of EXPAREL as a sciatic nerve block in the popliteal fossa for patients undergoing bunionectomy. The study revealed significant reductions in pain and opioid consumption through 96 hours, with a higher proportion of patients in the EXPAREL group requiring no rescue opioids[4].

Phase 4 Studies in Cesarean Section

In a Phase 4 CHOICE study, EXPAREL demonstrated superiority over morphine spinal-based standard care in patients undergoing Cesarean sections. The study showed a statistically significant reduction in total postsurgical opioid consumption and a decrease in the incidence and severity of itching for 72 hours post-surgery[3].

Efficacy and Safety Profile

EXPAREL has consistently shown a strong efficacy profile across various surgical models. Here are some key findings:

• Pain Control: EXPAREL provides superior postsurgical pain relief compared to bupivacaine HCl, with significant reductions in cumulative pain scores over extended periods (up to 96 hours)[1][4].
• Opioid Reduction: Studies have demonstrated a substantial reduction in opioid consumption, with some patients requiring no opioids at all through 72 or 96 hours post-surgery[1][3][4].
• Safety: EXPAREL has been well-tolerated, with a safety profile consistent with bupivacaine HCl. It has also shown a reduction in opioid-related side effects, such as itching[3].

Market Analysis

Current Market Position

EXPAREL is a market leader in non-opioid pain management, with over nine million patients having used the product since its launch. Its unique multivesicular liposome technology sets it apart from other local anesthetics, providing prolonged pain relief and reducing the need for opioids[1].

Reimbursement and Coding

Effective January 1, 2025, EXPAREL will have its own product-specific J-code (J0666), which is expected to streamline the reimbursement and billing process. This change is anticipated to increase clinician access to EXPAREL across various sites of care and payer types[5].

Market Projections

The introduction of the new J-code and the expanding label indications are expected to drive growth for EXPAREL. As more procedures migrate to outpatient settings, the demand for effective, long-lasting non-opioid pain management solutions is likely to increase. EXPAREL's ability to provide superior pain control without significant opioid use positions it for continued market dominance.

Impact on Opioid-Sparing Pain Management

EXPAREL is at the forefront of opioid-sparing pain management strategies. By significantly reducing the need for opioids, EXPAREL helps in mitigating opioid-related side effects and supports accelerated recovery. This aligns with the broader healthcare goal of minimizing opioid use and promoting safer pain management practices.

Clinician and Patient Benefits

• Extended Pain Relief: EXPAREL offers up to four days of superior non-opioid pain control, enhancing patient comfort and reducing the need for rescue opioids[1][4].
• Reduced Opioid Consumption: The significant reduction in opioid use decreases the risk of opioid-related adverse events and supports opioid-free recovery pathways[1][3][4].
• Simplified Reimbursement: The new J-code is expected to make the billing and reimbursement process more efficient, increasing access to EXPAREL for a broader patient population[5].

Future Directions

Pacira BioSciences plans to submit supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration to expand the EXPAREL label to include additional nerve block indications. This will further solidify EXPAREL's role in opioid-sparing postsurgical pain management regimens and support the transition of more procedures to outpatient settings[1].

Key Takeaways

• Clinical Efficacy: EXPAREL has demonstrated superior pain control and significant reductions in opioid consumption across various surgical models.
• Safety Profile: The product has a well-tolerated safety profile consistent with bupivacaine HCl.
• Market Position: EXPAREL is a leader in non-opioid pain management, with a growing market presence due to its unique delivery technology.
• Reimbursement: The introduction of a product-specific J-code in 2025 is expected to enhance access and streamline reimbursement.
• Future Directions: Pacira BioSciences is pursuing additional label indications to further expand EXPAREL's use in opioid-sparing pain management.

FAQs

What is EXPAREL and how does it work?

EXPAREL is a bupivacaine liposome injectable suspension that uses a multivesicular liposomal drug delivery technology to release bupivacaine over an extended period, providing long-lasting postsurgical pain relief.

What are the key benefits of using EXPAREL?

The key benefits include superior pain control for up to four days, significant reductions in opioid consumption, and a well-tolerated safety profile.

How does EXPAREL compare to bupivacaine HCl?

EXPAREL has shown statistically significant reductions in cumulative pain scores and opioid consumption compared to bupivacaine HCl in various clinical studies.

What is the new J-code for EXPAREL, and how will it impact reimbursement?

The new J-code (J0666) for EXPAREL, effective January 1, 2025, is expected to streamline the reimbursement and billing process, increasing access to EXPAREL across different sites of care and payer types.

What are the future directions for EXPAREL?

Pacira BioSciences plans to submit sNDAs to expand the EXPAREL label to include additional nerve block indications, further solidifying its role in opioid-sparing pain management.

Sources

1. Pacira Biosciences Announces Positive Topline Data from Phase 3 Study of EXPAREL as a Single-dose Femoral Nerve Block in the Adductor Canal for Total Knee Arthroplasty. Pacira BioSciences, Inc., September 7, 2022.
2. Pacira Pharmaceuticals, Inc. Announces Key EXPAREL™ Data to be Presented at American College of Surgeons 97th Annual Clinical Congress. Pacira Pharmaceuticals, Inc., October 18, 2011.
3. EXPAREL Achieves Primary and Key Secondary Endpoints in Phase 4 CHOICE Study in Cesarean Section Patients. Pacira BioSciences, Inc.
4. Pacira Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy. Pacira BioSciences, Inc., February 15, 2024.
5. Pacira BioSciences Announces New Product-Specific J-Code for EXPAREL Effective January 1, 2025. Pacira BioSciences, Inc., October 4, 2024.