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
China	2

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 Projections for EXPAREL (bupivacaine liposome injectable suspension)

Last updated: January 25, 2026

Summary

EXPAREL (bupivacaine liposome injectable suspension), developed by Pacira BioSciences, is a sustained-release local anesthetic used to manage postoperative pain. As of 2023, it is approved in multiple markets, including the U.S. and Europe, for various surgical procedures. This report provides a comprehensive analysis of recent clinical trials, market dynamics, and future projections to assist healthcare and industry stakeholders.

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Recent Clinical Trials Update

Overview of Clinical Trial Status

As of late 2023, EXPAREL has been extensively studied in multiple pivotal and confirmatory trials focused on both pain management effectiveness and safety in diverse surgical indications.

Trial Phase	Number of Trials	Main Indications	Notable Trials	Key Results
Phase 3	5	Orthopedic, Obstetric, Dental	NCT04008243, NCT02663079	Significant pain reduction, comparable or superior to alternatives, with favorable safety profiles.
Phase 4 (Post-marketing)	Ongoing/Completed	Hernia repair, bunionectomy, cesarean, orthopedic surgeries	NCT05902810, NCT03520891	Confirmed efficacy, consistent safety, approval extensions based on data.
Other Studies	10+	Multimodal analgesia, outpatient procedures	NCT04785887, NCT04945146	Data supports expanded indications and improved pain control metrics.

Key Clinical Outcomes

• Efficacy: Multiple trials demonstrate that EXPAREL offers superior analgesic duration (up to 72 hours), reducing postoperative opioid consumption by 40-60% (per study NCT04008243).
• Safety Profile: Adverse events comparable to placebo and active controls, with minimal systemic toxicity due to liposomal delivery.
• Special Populations: Trials in cesarean section and bariatric surgeries indicate safety and efficacy, supporting broader indications.

Regulatory Updates

• US FDA: Approved for paravertebral, nerve, and fascia plane blocks, along with infiltration for various surgeries.
• European Medicines Agency (EMA): Approves for similar indications, with ongoing applications for additional uses.
• Other Regions: Approval in Canada, Australia, Japan, with local clinical data supporting indications.

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Market Analysis

Market Overview

The global surgical analgesics market, valued at approximately USD 2.5 billion in 2022, is driven by increasing surgical volumes, patient preference for opioid-sparing pain management, and regulatory shifts favoring local anesthetics.

Market Segment	Size (2022 USD)	CAGR (2023-2028)	Key Drivers	Major Competitors
Postoperative analgesics	1.2 billion	8%	Rise in outpatient surgeries, opioid crisis response	Lidocaine, opioids, other sustained-release formulations
Orthopedic surgeries	700 million	9%	Demand for long-acting pain relief, faster recovery	Exparel, traditional local anesthetics

Regional Market Distribution

Region	Market Share (2022)	Growth Rate (2023-2028)	Notable Trends
North America	50%	8-10%	Dominant due to high surgical volume, strong healthcare infrastructure
Europe	25%	7-9%	Growing awareness, healthcare reform initiatives
Asia-Pacific	15%	12%	Rapid surgical expansion, unmet need for advanced pain management
Rest of World	10%	7-8%	Emerging markets, expanding hospital infrastructure

Competitive Landscape

Company	Main Product	Market Share (2023)	Strengths	Weaknesses
Pacira BioSciences	EXPAREL	~60%	First-to-market, extensive data, multiple approvals	Costly, limited indications in some regions
B. Braun	Levobupivacaine	15%	Established local anesthetic, lower price	Less sustained release than EXPAREL
Pfizer	Bupivacaine formulations	10%	Broad portfolio, global reach	Less focused on sustained-release

Pricing & Reimbursement Environment

• Pricing: Premium pricing (~USD 300-400 per dose), justified by extended efficacy.
• Reimbursement: Generally covered under hospital and outpatient surgical procedure codes; payer uptake varies by region.
• Challenges: Cost-effectiveness debates amid rising healthcare costs and biosimilar pressures.

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Market Projections

Growth Drivers

• Surge in outpatient and minimally invasive surgeries.
• Rising preference for non-opioid analgesics to mitigate opioid-related crises.
• Expanding indications based on ongoing clinical trial data.
• Strategic partnerships and regional approvals.

Projected Market Size

Year	Estimated Market Value (USD)	Key Notes
2023	$2.75 billion	Base year with expanding indications.
2025	$3.2 billion	Increased regional approvals, IM sales growth.
2030	$4.8 billion	Broader indications, competitive advantages, new formulations.

Market Share Forecasts

Company/Compound	2023 Market Share	2030 Projection
EXPAREL (Pacira)	60%	65%
Competitors	Combined 40%	35%

Key Factors Influencing Future Growth

• Expansion into additional indications (e.g., chronic pain, nerve blocks).
• Adoption in emerging markets.
• Potential for new liposomal formulations or combination products.
• Pricing strategies and payer acceptance.

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Comparative Analysis: EXPAREL vs. Competitors

Feature	EXPAREL	Lidocaine (standard)	Other Sustained-Release Local Anesthetics
Duration	Up to 72 hours	1-2 hours	Varies, generally shorter
Delivery Mechanism	Liposomal formulation	Direct injection	Microcapsules, non-liposomal systems
Opioid Sparing	Significant	Limited	Variable
Approval	Multiple surgical indications	Variable	Experimental/comparative
Cost	Premium	Lower	Lower

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FAQs

1. What are the key advantages of EXPAREL over traditional local anesthetics?
   EXPAREL provides up to 72 hours of analgesia, significantly reducing opioid requirements and improving patient comfort in the postoperative period. Its sustained-release liposomal delivery minimizes systemic toxicity and enhances pain control efficacy.

2. How do recent clinical trials support EXPAREL’s expanding indications?
   Trials demonstrate consistent efficacy and safety across diverse surgical procedures, including orthopedic, obstetric, and dental surgeries, enabling approvals for broader use and improved pain management protocols.

3. What are the current challenges facing EXPAREL in the global market?
   Pricing and reimbursement hurdles, competition from generic or non-liposomal alternatives, and regulatory variances hinder universal adoption. Cost-effectiveness debates and regional healthcare policies influence uptake.

4. What future developments are anticipated for EXPAREL?
   Expect expanded indications, research into combination formulations, and increased uptake in outpatient and ambulatory settings. Clinical trials focus on chronic pain and nerve blocks to widen its therapeutic scope.

5. How does the competitive landscape influence EXPAREL’s market share?
   Though EXPAREL dominates with ~60% market share (2023), competitors’ innovations, pricing strategies, and regional approval trajectories could impact its dominance, especially as biosimilars and generics emerge.

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Key Takeaways

• Clinical Evidence: Robust late-phase clinical trials confirm EXPAREL's efficacy in extended postoperative analgesia with a favorable safety profile. Ongoing studies support its broader applicability.
• Market Position: EXPAREL maintains a leading position within the surgical analgesic market, driven by extensive patent protection, regulatory approvals, and clinical data.
• Growth Outlook: The global market is projected to grow at a compounded rate of 8-10% through 2030, propelled by surgical volume increase and the opioid crisis response.
• Strategic Opportunities: Expansion into new indications and regions, along with ongoing clinical validation, offers growth avenues for Pacira BioSciences.
• Challenges: Pricing, reimbursement, and emerging competitors necessitate strategic pricing and innovation to sustain market leadership.

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References

[1] Pacira BioSciences, “EXPAREL Prescribing Information,” 2022.

[2] MarketsandMarkets, “Surgical Analgesics Market,” 2023.

[3] ClinicalTrials.gov, “EXPAREL Clinical Trials,” 2023.

[4] IQVIA, “Healthcare Data & Insights,” 2023.

[5] U.S. Food and Drug Administration, “Drug Approvals & Safety,” 2022-2023.