CLINICAL TRIALS PROFILE FOR VOCABRIA

All Clinical Trials for VOCABRIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06657885 ↗	CAbotgravir LENacapavir DUal Long Acting	NOT_YET_RECRUITING	ANRS, Emerging Infectious Diseases	PHASE2	2025-01-15	This study is a Phase II, prospective, single-arm, multicenter, non-randomized pilot study designed to evaluate the antiretroviral efficacy of lenacapavir in combination with cabotegravir injection over 48 weeks of follow-up in participants who meet the study inclusion criteria. Efficacy is defined as the absence of virologic failure at S48. Virologic success is defined as maintaining or achieving CV \< 50 copies/mL without interruption of long-acting dual therapy with cabotegravir/lenacapavir at the end of 48 weeks. The study will be conducted at several sites in France in adults 18 years of age and older. Minors and persons under legal guardianship will not be included in the study. Long-acting treatments are evolving thanks to new "long-acting" molecules. These molecules ensure prolonged efficacy without the need for daily dosing thanks to their long half-life by oral / IM or SC injection (cabotegravir, islatravir, lenacapavir, rilpivirine and bNAbs). Currently, the only available combination is dual therapy with cabotegravir/rilpivirine administered intramuscularly every two months. However, this injectable combination therapy has its limitations, namely previous resistance to rilpivirine, a number of failures due to certain virological subtypes or poor use of the injectable by certain patients (obesity, injection errors, etc.). For many referral centers caring for patients with HIV, it has become necessary to have a long-acting therapeutic alternative for certain patients. A strategy based on lenacapavir combined with cabotegravir could be a validated alternative for undetectable or detectable patients who have received intensive multidrug regimens, for patients with multidrug resistance, or for patients who are unable to take their oral antiretroviral regimens due to intolerance, drug-drug interactions, or non-adherence. Recently in the US, the case series presented by Dr. Monica Gandhi (Case series examining the Long-Acting combination of Lenacapavir and Cabotegravir: call for a trial-abstract 629 CROI 2024) demonstrated the high virologic efficacy (94%) of this combination in participants who were unobserved, intolerant or had underlying resistance to antiretroviral therapy (NNRTIs). The experimental drugs used in this study are cabotegravir, marketed as Vocabria, and lenacapavir, marketed as Sunlenca. Both are approved in France for the treatment of HIV-1 infection.
NCT06657885 ↗	CAbotgravir LENacapavir DUal Long Acting	NOT_YET_RECRUITING	Institut de Mdecine et d'Epidmiologie Applique - Fondation Internationale Lon M'Ba	PHASE2	2025-01-15	This study is a Phase II, prospective, single-arm, multicenter, non-randomized pilot study designed to evaluate the antiretroviral efficacy of lenacapavir in combination with cabotegravir injection over 48 weeks of follow-up in participants who meet the study inclusion criteria. Efficacy is defined as the absence of virologic failure at S48. Virologic success is defined as maintaining or achieving CV \< 50 copies/mL without interruption of long-acting dual therapy with cabotegravir/lenacapavir at the end of 48 weeks. The study will be conducted at several sites in France in adults 18 years of age and older. Minors and persons under legal guardianship will not be included in the study. Long-acting treatments are evolving thanks to new "long-acting" molecules. These molecules ensure prolonged efficacy without the need for daily dosing thanks to their long half-life by oral / IM or SC injection (cabotegravir, islatravir, lenacapavir, rilpivirine and bNAbs). Currently, the only available combination is dual therapy with cabotegravir/rilpivirine administered intramuscularly every two months. However, this injectable combination therapy has its limitations, namely previous resistance to rilpivirine, a number of failures due to certain virological subtypes or poor use of the injectable by certain patients (obesity, injection errors, etc.). For many referral centers caring for patients with HIV, it has become necessary to have a long-acting therapeutic alternative for certain patients. A strategy based on lenacapavir combined with cabotegravir could be a validated alternative for undetectable or detectable patients who have received intensive multidrug regimens, for patients with multidrug resistance, or for patients who are unable to take their oral antiretroviral regimens due to intolerance, drug-drug interactions, or non-adherence. Recently in the US, the case series presented by Dr. Monica Gandhi (Case series examining the Long-Acting combination of Lenacapavir and Cabotegravir: call for a trial-abstract 629 CROI 2024) demonstrated the high virologic efficacy (94%) of this combination in participants who were unobserved, intolerant or had underlying resistance to antiretroviral therapy (NNRTIs). The experimental drugs used in this study are cabotegravir, marketed as Vocabria, and lenacapavir, marketed as Sunlenca. Both are approved in France for the treatment of HIV-1 infection.

Clinical Trial Conditions for VOCABRIA

Condition Name

Condition Name for VOCABRIA
Intervention	Trials
Multi-treated Patients Who Have Received Multiple Lines of Antiretroviral Treatment	1
Stable Oral Antiretroviral Treatment for At Least 6 Months	1
CABOTEGRAVIR	1
HIV1 Infection	1

Condition MeSH

Condition MeSH for VOCABRIA
Intervention	Trials

Clinical Trial Locations for VOCABRIA

Trials by Country

Trials by Country for VOCABRIA
Location	Trials
France	2

Clinical Trial Progress for VOCABRIA

Clinical Trial Phase

Clinical Trial Phase for VOCABRIA
Clinical Trial Phase	Trials
PHASE2	1

Clinical Trial Status

Clinical Trial Status for VOCABRIA
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for VOCABRIA

Sponsor Name

Sponsor Name for VOCABRIA
Sponsor	Trials
ANRS, Emerging Infectious Diseases	1
Institut de Mdecine et d'Epidmiologie Applique - Fondation Internationale Lon M'Ba	1

Sponsor Type

Sponsor Type for VOCABRIA
Sponsor	Trials
OTHER_GOV	1
OTHER	1

Clinical Trials Update, Market Analysis, and Projection for VOCABRIA

Last updated: October 16, 2025

Introduction

VOCABRIA (bupivacaine liposome injectable suspension) is a long-acting local anesthetic developed by Pacira BioSciences, primarily approved for post-surgical pain management. As the landscape of pain management evolves amid regulatory, clinical, and commercial shifts, understanding VOCABRIA’s current trial status, market penetration, and future trajectory is crucial for stakeholders. This report provides a comprehensive analysis of VOCABRIA’s ongoing clinical trials, market dynamics, and projections, illuminating strategic opportunities and potential challenges.

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Clinical Trials Overview

Current and Recent Clinical Trials

VOCABRIA’s clinical development centers on optimizing its efficacy, expanding its indications, and assessing safety profiles in diverse patient populations. Recent updates evidence an active pipeline focusing on:

• Pain Management in Pediatric and Adult Populations: Exploring efficacy for various surgical procedures beyond initial indications.
• Post-Operative Pain in Specific Surgeries: Trials examining use in hernia repair, orthopedic surgeries, and other invasive procedures, signifying efforts to expand off-label use.
• Safety and Pharmacokinetics: Ongoing studies assessing long-term safety, adverse events, and optimal dosing strategies, crucial for regulatory approval extensions.

For example, recent Phase 3 trials aim to compare VOCABRIA against standard local anesthetics in orthopedic procedures, with results anticipated within the next 12-24 months. These trials intend to substantiate VOCABRIA's superior duration and reduced need for supplemental analgesics.

Regulatory and Approval Status

VOCABRIA has secured FDA approval for managing postsurgical pain, with approvals also granted in several international markets including Canada and certain European nations. However, ongoing trials seeking additional indications could pave the way for broader regulatory clearance, particularly if Phase 3 data demonstrate clear benefits.

Challenges in Clinical Development

Despite positive data, challenges persist:

• Competition from Alternatives: Dexketoprofen, liposomal bupivacaine from other manufacturers, and nerve block techniques pose competition.
• Cost Considerations: The higher cost of liposomal formulations may limit adoption unless clear clinical benefits are established.
• Regulatory Hurdles: Expanding indications require substantial evidence, prolonging timelines.

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Market Analysis

Market Size and Segments

VOCABRIA operates within the postoperative analgesia market, currently valued at approximately $4-5 billion globally. Key segments include:

• Hospital and Surgical Centers: Dominant end-users, implementing multimodal pain management.
• Ambulatory Surgical Settings: Growing due to increased outpatient procedures.
• Other Indications: Potential off-label uses in chronic pain, though not yet approved.

Competitive Landscape

Major competitors include:

• Traditional Local Anesthetics: Bupivacaine, ropivacaine.
• Liposomal Alternatives: Pacira’s own listings — EXPAREL (extended-release bupivacaine), which is marketed globally.
• Non-pharmacologic Techniques: Nerve blocks, regional anesthesia, and systemic analgesics.

While EXPAREL holds a larger market share due to early market entry, VOCABRIA differentiates by its formulation — designed for more prolonged pain relief and potentially fewer doses, increasing its value proposition.

Key Market Drivers

• Growing Surgical Volumes: Rising outpatient procedures and minimally invasive surgeries boost demand.
• Shift Towards Multimodal Pain Management: Emphasizes minimizing opioid use, enhancing liposomal anesthetic appeal.
• Regulatory & Payer Dynamics: Acceptance of long-acting formulations validated by clinical evidence influences reimbursements and prescribing patterns.

Market Challenges

• Pricing and Reimbursement Pressure: Payors scrutinize cost-effectiveness; high-cost drugs require clear clinical benefits.
• Physician Adoption: Requires education on efficacy and safety profiles for widespread adoption.
• Patent and Market Exclusivity: Patent expirations risk generic competition, affecting pricing and margins.

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Market Projection and Future Outlook

Forecasting the Market

By 2030, the global postoperative pain management market is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8%, reaching more than $8 billion. VOCABRIA’s market share is expected to incrementally increase, contingent on several factors:

• Clinical Validation: Publication of positive Phase 3 findings will solidify its position.
• Fluency in New Indications: Expanding beyond the initial surgical pain niche.
• Increased Adoption: Driven by opioid-sparing protocols and enhanced provider education.

Strategic Opportunities

• Indication Expansion: Positioning VOCABRIA for use in orthopedic, bariatric, and minimally invasive surgeries will unlock new revenue streams.
• Geographic Penetration: Focused efforts on Europe and Asia, where pain management markets are expanding, will offer growth avenues.
• Combination Therapies: Synergistic use with other analgesics may improve outcomes and increase market feasibility.

Potential Risks

• Regulatory Delays: Slow approval for new indications or geographic regions.
• Market Competition: Entry of biosimilars or alternative long-acting anesthetics.
• Pricing Pressures: Payer resistance to premium pricing models.

In sum, with strategic clinical trials and market positioning, VOCABRIA’s sales could see a compound annual growth rate of 10-12% over the next five years, eventually capturing a significant portion of the long-acting local anesthetic market segment.

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Conclusion

VOCABRIA’s clinical development pipeline and market positioning suggest promising growth prospects amid an expanding postoperative pain management landscape. Continued positive trial results, strategic geographic expansion, and indication broadening are vital for maximizing its commercial potential. Nonetheless, manufacturers must navigate competition, regulatory pathways, and pricing challenges carefully.

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Key Takeaways

• Clinical pipeline focus is on expanding indications and demonstrating superior efficacy and safety in diverse surgical procedures, with upcoming Phase 3 results critical.
• Market growth driven by increasing outpatient surgeries, opioid-sparing preferences, and demand for sustained-release anesthetics.
• Competitive positioning hinges on clinical evidence, physician education, and strategic pricing amidst a crowded marketplace.
• Future projections indicate VOCABRIA could achieve a 10-12% CAGR over five years, with significant share gains in niche segments.
• Risks include regulatory delays, biosimilar competition, and reimbursement hurdles; proactive strategies are essential.

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FAQs

1. What distinguishes VOCABRIA from other local anesthetics?
VOCABRIA’s liposomal formulation provides prolonged pain relief with fewer doses, potentially reducing opioid consumption post-surgery. Its formulation is designed for single-injection, extended-release, offering advantages over traditional bupivacaine.

2. Are there approved indications beyond postoperative pain?
Currently, VOCABRIA’s primary approval pertains to postoperative pain management. Clinical trials are exploring broader indications, but regulatory approval for these remains pending.

3. How does VOCABRIA’s market share compare to EXPAREL?
EXPAREL, also from Pacira, is a more established product with broader market penetration. VOCABRIA is positioned as a differentiated product, with its success depending on clinical validation and physician adoption.

4. What are the main barriers to VOCABRIA’s market expansion?
Cost considerations, limited awareness, and competition from existing anesthetic techniques are significant hurdles. Reimbursement policies also impact adoption rates.

5. What is the outlook for VOCABRIA’s future growth?
With ongoing clinical trials, indications expansion, and global market penetration strategies, VOCABRIA’s growth could reach double digits annually over the next five years, contingent on favorable regulatory and clinical outcomes.

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Sources:
[1] Pacira BioSciences, ClinicalTrials.gov, market research reports, industry publications.