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.
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Atrium Health Levine Cancer Institute	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Wake Forest University Health Sciences	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.

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.

Clinical Trial Conditions for EXPAREL

Condition Name

Condition Name for EXPAREL
Intervention	Trials
Pain, Postoperative	47
Pain	32
Postoperative Pain	31
Opioid Use	14

Condition MeSH

Condition MeSH for EXPAREL
Intervention	Trials
Pain, Postoperative	109
Osteoarthritis	17
Rotator Cuff Injuries	13
Fractures, Bone	11

Clinical Trial Locations for EXPAREL

Trials by Country

Trials by Country for EXPAREL
Location	Trials
United States	390
Denmark	4
Hong Kong	3
Belgium	3
Georgia	1

Trials by US State

Trials by US State for EXPAREL
Location	Trials
Texas	38
Ohio	36
New York	31
California	30
North Carolina	25

Clinical Trial Progress for EXPAREL

Clinical Trial Phase

Clinical Trial Phase for EXPAREL
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	6
PHASE2	3

Clinical Trial Status

Clinical Trial Status for EXPAREL
Clinical Trial Phase	Trials
Completed	114
Recruiting	57
Terminated	36

Clinical Trial Sponsors for EXPAREL

Sponsor Name

Sponsor Name for EXPAREL
Sponsor	Trials
Pacira Pharmaceuticals, Inc	65
Mayo Clinic	13
Rothman Institute Orthopaedics	8

Sponsor Type

Sponsor Type for EXPAREL
Sponsor	Trials
Other	289
Industry	72
U.S. Fed	7

Clinical Trials Update, Market Analysis, and Projection for EXPAREL (Bupivacaine Liposome Injectable Suspension)

Last updated: October 26, 2025

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Introduction

EXPAREL (bupivacaine liposome injectable suspension), developed by Pacira BioSciences, is an extended-release local anesthesia used primarily for postsurgical pain management. Approved by the FDA in 2011, EXPAREL has carved a niche within the multi-billion-dollar analgesic market by offering sustained pain relief with a single administration. As pain management therapies evolve amid regulatory and competitive pressures, understanding the current clinical trial landscape, market dynamics, and future projections is essential for investors, healthcare providers, and industry stakeholders.

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Clinical Trials Landscape and Updates

Since its initial approval, EXPAREL has been the subject of multiple clinical trials aimed at broadening its indications, optimizing delivery methods, and assessing its safety profile across diverse patient populations.

Expanding Indications and New Clinical Trials

Currently, EXPAREL's trials focus on its utility in procedures beyond initial surgical posts, including its efficacy in orthopedic, dental, and cesarean-section surgeries. Noteworthy trials include:

• Orthopedic Procedures: Recent Phase IV studies evaluate EXPAREL as part of multimodal analgesia in joint replacements. Preliminary data suggest significant reductions in opioid consumption and adverse events, aligning with the current trend of opioid-sparing strategies.

• Chronic Pain and Regional Blocks: Trials are assessing EXPAREL's application in nerve blocks and chronic pain management, potentially broadening its therapeutic scope. These studies aim to establish long-term safety and efficacy, which remain critical for regulatory expansion.

• Pediatric and Special Population Studies:
  Ongoing research aims to evaluate safety and dosing in pediatric, elderly, and comorbid populations. These trials are pivotal, considering the expanding use of anesthetic agents in diverse demographic groups.

Safety Profiles and Challenges

Clinical data reinforce EXPAREL's safety, with most adverse events being mild or moderate, including wound-related complications and transient local anesthesia effects. However, ongoing trials are scrutinizing potential local tissue reactions, systemic toxicity, and rare hypersensitivity responses, to fortify its safety dossier.

Regulatory Endeavors

Although the FDA approved EXPAREL for infiltration and peripheral nerve block in various surgeries, Pacira pursued supplemental approvals to extend its use further. Notably, trials supporting its application in cesarean sections have been conducted, with some progressing toward regulatory submission.

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Market Analysis

Current Market Position

EXPAREL's niche focus on non-opioid, long-lasting analgesia makes it attractive amid the global opioid crisis. As of 2023, Pacira remains the sole significant manufacturer, giving it a competitive edge, although generics and alternative formulations threaten its market share.

Market Segments and Geographies

• Hospital and Surgical Centers:
  Predominant sales derive from hospital procedures, especially orthopedic, ear/nose/throat (ENT), and dental surgeries.

• Geographical Reach:
  North America dominates sales, accounting for approximately 85%, driven by high surgical volumes and opioid reduction initiatives. Europe and Asia-Pacific represent growing markets, with expansion constrained by regulatory approval timelines.

• Competitive Landscape:
  While EXPAREL faces competition from pure local anesthetics (e.g., ropivacaine, lidocaine) and emerging non-opioid analgesics, its unique liposomal delivery affords prolonged pain relief, a key differentiator.

Market Challenges

• Price and Reimbursement:
  EXPAREL is priced higher than traditional anesthetics, which can hamper adoption in cost-sensitive healthcare systems.

• Generic Competition:
  Pending patents and market exclusivity are critical, with some formulations approaching expiration, risking generic entries that could significantly erode margins.

• Regulatory and Reimbursement Policies:
  Changes in reimbursement rates and surgical reimbursement policies influence adoption rates, especially in cost-containment environments.

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Market Projection and Future Opportunities

Growth Drivers

• Increase in Surgical Procedures:
  The global rise in elective surgeries, particularly orthopedic joint replacements and cesarean sections, fuels demand for effective postoperative analgesia.

• Focus on Opioid-Sparing Strategies:
  Policies promoting non-opioid pain management bolster EXPAREL’s market position, supported by increasing prescriber awareness and patient demand.

• Potential Expansion of Indications:
  FDA approval for additional procedures, including chronic pain, nerve blocks, and pediatric use, could substantially enlarge the market.

• Technological and Formulation Innovations:
  Developing combination therapies or improved delivery systems (e.g., biosensors for drug release) could maintain competitiveness and open new markets.

Market Forecast

By 2030, analysts project the global local anesthetics market to surpass USD 11 billion, with EXPAREL expected to retain a significant share due to its distinct liposomal technology. Pacira’s strategic focus on expanding indications is projected to amplify revenues, with estimates suggesting Compound Annual Growth Rate (CAGR) between 7-10% over the next five years.

Key Risks

• Patent expirations could lead to generic competition, suppressing prices and market share.
• Regulatory delays or rejection of new indications may hinder growth.
• Prices and reimbursement dynamics could constrain market uptake in lower-income regions.

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Conclusion and Key Takeaways

EXPAREL remains a pioneering product in the non-opioid, extended-release local anesthesia sector. Its ongoing clinical trials aim to broaden its indications and reaffirm safety, underpinning future adoption. The expanding global surgical volume, shifting policies toward opioid reduction, and technological innovations serve as catalysts for growth. However, patent expirations, competitive pressures, and pricing strategies warrant continuous monitoring.

Informed decision-makers should consider these factors in investment, procurement, and R&D strategies, emphasizing expansion into new procedural areas and addressing competitive threats proactively.

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FAQs

1. What is the primary clinical advantage of EXPAREL over traditional local anesthetics?
   EXPAREL offers extended pain relief—up to 72 hours—thanks to liposomal encapsulation, reducing the need for multiple injections and opioid use.

2. Are there any approved uses of EXPAREL beyond surgical infiltration?
   Yes, EXPAREL is approved for infiltrative anesthesia and peripheral nerve blocks in various surgeries; additional indications are under clinical investigation.

3. How does opioid reduction influence the market for EXPAREL?
   The push to limit opioid prescriptions enhances demand for non-opioid alternatives like EXPAREL, positioning it favorably in pain management protocols.

4. What impact could patent expirations have on EXPAREL’s market?
   Patents protecting EXPAREL's formulation are approaching expiry in key markets, risking generic competition that could lower prices and market share.

5. What are the upcoming regulatory milestones for EXPAREL?
   Pacira aims to secure approvals for expanded indications in procedures like cesarean sections and chronic pain, contingent upon successful clinical trial outcomes and submission reviews.

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References

1. Pacira BioSciences. (2022). EXPAREL Prescribing Information.
2. Market research reports on local anesthetics (2023).
3. FDA approvals and trial registries.
4. Industry analyst insights on pain management market dynamics.
5. Recent clinical trial publications in anesthesia journals.

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Disclaimer: This analysis synthesizes publicly available data and projections as of 2023. Market conditions and clinical landscapes evolve; stakeholders should consult latest sources for real-time decision-making.