Total knee arthroplasty is a commonly performed orthopaedic surgery for the treatment of end-stage osteoarthritis when conservative management becomes ineffective. TKA is associated with significant acute postoperative pain and many patients experience severe postoperative pain despite the use of multimodal analgesia. Poor acute postoperative pain control impacts rehabilitation, prolongs recovery and increases opioid consumption and chronic post-surgical pain.
Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals Inc, Parsippany, New Jersey, USA) is a multivesicular formulation of bupivacaine that prolongs drug release and can extend the duration of analgesia. The adductor canal block (ACB) has been shown to reduce pain intensity and opioid consumption after total knee arthroplasty. The use of liposomal bupivacaine in the adductor canal block has recently been FDA-approved. However, the results of its efficacy from existing clinical trials have been mixed. In addition, the doses in the clinical trials have been different, and the optimal dose for perineural application of liposomal bupivacaine is unclear, including for the adductor canal block.
In this project, the investigators propose to conduct a randomized controlled trial to investigate the effect of different doses of liposomal bupivacaine in the adductor canal block on acute postoperative pain intensity and opioid consumption after total knee arthroplasty. The investigators will also assess secondary outcomes including knee functional scores, chronic pain and quality of recovery.

Start Date01 Jul 2025

Sponsor / Collaborator

The University of Hong Kong

NCT06995352

/ Not yet recruitingPhase 4IIT

Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery: A Randomized, Observer and Participant Masked, Active Control, Non-Inferiority Study

Postoperative pain remains undertreated. Opioids have well-known limitations for both individuals and society, and while single-injection peripheral nerve blocks with unencapsulated local anesthetic provide potent analgesia, their duration is measured in hours while post-surgical pain usually outlasts this duration. Continuous peripheral nerve blocks prolong analgesia but may possibly be replaced with liposomal bupivacaine with a reported duration of up to 72-96 hours (Schwartz. J Clin Anesth 2024). In comparison to continuous peripheral nerve blocks, liposomal bupivacaine eliminates a time-consuming catheter insertion as well as the risks of catheter dislodgement, localized infection, local anesthetic leakage, and infusion pump malfunction. Furthermore, liposomal bupivacaine significantly reduces the burden on both patients and healthcare providers as it does not require the use of a portable infusion pump, local anesthetic reservoir, or perineural catheter to be carried, managed, or eventually removed. Notably, the potential for local anesthetic-induced myotoxicity, and cardiac/neurologic toxicity is reduced or negated altogether. And the cost of liposome bupivacaine is less than the combined cost of a catheter set, insertion equipment, portable infusion pump, large reservoir of local anesthetic, and healthcare provider oversight.
Therefore, should a single injection of liposomal bupivacaine be demonstrated to provide at least non-inferior analgesia and opioid sparing as a continuous peripheral nerve block, it would be a far superior analgesic benefiting patients, providers, hospitals, and payers such as Medicare and private health insurance. Randomized, active-controlled clinical trials are required to compare the newer liposomal bupivacaine to continuous peripheral nerve blocks. The ultimate objective of the proposed research study is to determine if liposomal bupivacaine in a peripheral nerve block is at least non-inferior to a continuous peripheral nerve block following moderate-to-severely painful ankle surgery.
This is a single-center clinical trial. The investigators will randomize participants to either a liposomal bupivacaine combined with unencapsulated bupivacaine single-injection popliteal-sciatic and saphenous nerve block group, or single injections of unencapsulated bupivacaine followed by a continuous popliteal-sciatic bupivacaine infusion.

Start Date15 Jun 2025

Sponsor / Collaborator

University of California San Diego

[+1]

NCT06559215

/ Not yet recruitingPhase 2IIT

Prospective Evaluation of Post-operative Pain Management Using Exparel in the Pediatric Population

The goal of this randomized clinical trial is to determine if administration of Exparel via local infiltration for medial patellofemoral ligament (MPFL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are:
* Does Exparel significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively?
* Does Exparel significantly decrease narcotic use (number of pills taken) up to one week postoperatively?
Researchers will compare the pain outcomes and narcotic use of patients who receive Exparel and Marcaine via local infiltration to those of patients who receive only Marcaine via local infiltration for their MPFL reconstruction surgery. The goal is to understand if there is a significant difference in patient pain outcomes and narcotic use outside the first 24 hours postoperatively.
Participants will:
* receive either Exparel + Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery
* receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction
* receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery at postoperative day 1

Start Date01 Jun 2025

Sponsor / Collaborator

Texas Scottish Rite Hospital for Children

100 Clinical Results associated with Bupivacaine liposome

100 Translational Medicine associated with Bupivacaine liposome

100 Patents (Medical) associated with Bupivacaine liposome

812

Literatures (Medical) associated with Bupivacaine liposome

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Effects of liposomal bupivacaine (LB) and provider experience with LB on service utilization, clinical outcomes, and Medicare expenditures among fee-for-service (FFS) beneficiaries

Article

Author: Heath, Steven ; Pal, Sarmistha ; Zirath, Richa ; Beins, Michael ; Kim, Seung ; Dobson, Al ; Kim, Sung

OBJECTIVE:

To assess the effects of Liposomal Bupivacaine (LB) and provider LB use rate for 6 months after discharge on service utilization, clinical outcomes, and Medicare expenditures among Fee for Service (FFS) beneficiaries who have undergone hospital outpatient department (HOPD) procedures.

METHODS:

100% Medicare Research Identifiable Files data from 2019 to 2023 was utilized. Medicare FFS beneficiaries with the top 100 HOPD surgical procedures where LB was utilized were included in the study and divided into two cohorts: received LB (treatment) and did not receive LB (comparison) during the surgical procedure. An Inverse Probability Treatment Weighting Propensity Score model was estimated to balance treatment and control groups. We estimated Emergency Department (ED) admission, Short Term Acute Care Hospitals (STACH) admission, mortality, Opioid Use Disorder (OUD) and Opioid prescription fill events, and spending metrics.

RESULTS:

LB use contributed to significant reductions in ED admission (9%; 23.28 vs. 25.69%), STACH admission (8%; 11.61 vs. 12.65%), mortality (39%; 0.67 vs. 1.1%) and opioid prescription fills (6%; 1.8 vs. 1.92) within 180-days post-discharge. Total Medicare expenditures (180-day episode) were $245 lower for the LB user ($9,645 vs. $9,891). For each 10-percentage point increase in provider LB use-rate, the likelihood of ED admission, STACH admission, mortality, and OUD decreased by 0.1, 0.15, 0.01 and 0.02 percentage points, respectively. Total Medicare expenditures (180-day episode) were reduced by $258 for every one percentage point increase in LB use-rate.

CONCLUSION:

Use of LB and provider LB use rate are associated with improved patient clinical, service utilization, and expenditure outcomes.

01 Aug 2025·Journal of Vascular Surgery Cases Innovations and Techniques

Liposomal bupivacaine infiltration for postprocedural analgesia following interventional procedures for vascular anomalies

Article

Author: Padua, Horacio ; Amarneh, Mohammad A ; Alomari, Ahmad I ; Kim, Kyung ; Chaudry, Gulraiz ; Kerr, Cindy L ; Shaikh, Raja

We describe the use and assess the safety of liposomal bupivacaine (LB) infiltration for prolonged postprocedural analgesia after procedures to treat vascular anomalies. This is a single-center prospective study. Consecutive patients aged ≥6 years undergoing painful interventions for vascular anomalies were included. Data collected included patient demographics, diagnosis, procedure details, LB dosage, periprocedural pain levels, side effects, and the use of additional analgesics. Follow-up extended through postprocedural day 5. LB was used in 26 procedures in 24 patients with mean age of 17.0 years (range, 6.0-33.0 years; median, 17.5 years). One patient was excluded owing to a lack of follow-up. Twenty patients did not require any pain medication in the recovery unit. The mean pain level was 4, 2, 2, and 2 on postoperative days 1, 2, 3, and 5, respectively. No side effects were noted. LB proved to be a safe and likely effective local anesthetic agent, providing prolonged postprocedural analgesia for patients undergoing painful treatments for vascular anomalies.

01 Aug 2025·PEDIATRIC TRANSPLANTATION

Liposomal Bupivacaine in Single‐Injection Quadratus Lumborum Block for Pediatric Kidney Transplant: Case Report of a Novel Application

Article

Author: Bonaroti, Rebecca ; Visoiu, Mihaela ; Ganoza, Armando

ABSTRACT:

Background:

Liposomal bupivacaine is FDA‐approved long‐acting bupivacaine for intraoperative local wound infiltration in pediatric patients 6 years and older, but not for ultrasound‐guided peripheral nerve blocks. There are few prior reports of using liposomal bupivacaine for preoperative peripheral nerve blocks in pediatric patients. We report the first use of liposomal bupivacaine in a single‐injection quadratus lumborum block in a pediatric patient undergoing a kidney transplant.

Methods:

Our patient is a 16‐year‐old female undergoing a living‐related kidney transplant for end‐stage renal disease. Pertinent past medical history includes symptoms of opioid withdrawal during a prior hospitalization. To optimize postoperative pain control, a preoperative single injection quadratus lumborum nerve block was performed with liposomal bupivacaine, and opioids and acetaminophen were administered as needed in the perioperative period.

Results:

The patient had excellent pain control for the first 36 h postoperatively and adequate pain control for the entire hospital stay, with minimal opioid administration. She reported decreased sensation to temperature and touch over her entire ipsilateral abdomen/flank for the first 48 h. Postoperative day 4 marked her highest average pain score, coinciding with the reported 72 h of efficacy of liposomal bupivacaine. She was able to ambulate less than 24 h postoperatively, did not report any withdrawal symptoms, and had no adverse events.

Conclusions:

This is the first documented case of liposomal bupivacaine in a preoperative quadratus lumborum nerve block for a pediatric patient. More studies are required to investigate the pharmacokinetics of liposomal bupivacaine in kidney recipients and determine its efficacy and safety.

News (Medical) associated with Bupivacaine liposome

12 Jun 2025

·pipelinereview.com

Pacira BioSciences Unveils Three-Year Clinical Data Following a Single Local Administration of Investigational Gene Therapy, PCRX-201, in Patients with Moderate-to-Severe Osteoarthritis of the Knee

— PCRX-201 demonstrated sustained clinical efficacy with improvements in pain, stiffness, and function for up to three years – BRISBANE, CA, USA I June 11, 2025 I Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced new long-term follow-up data from its Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a novel gene therapy candidate for osteoarthritis of the knee. Results show that a single intra-articular injection of PCRX-201 was well tolerated and produced sustained improvements in pain, stiffness, and function through 156 weeks in patients with moderate-to-severe osteoarthritis of the knee. The study findings will be presented during a poster session at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain, on Wednesday, June 11, from 3:30 to 4:30 PM CET. “The three-year data from this trial underscore the potential of PCRX-201 to meaningfully change the treatment paradigm for patients living with osteoarthritis of the knee,” said Philip G. Conaghan, Professor of Musculoskeletal Medicine at the University of Leeds and lead author on the study. “Current osteoarthritis treatments target its symptoms and are limited to three to six months of pain relief. With PCRX-201, we are targeting chronic inflammation at the cellular level to address a root cause of osteoarthritis. Providing three or more years of improvements in pain and function while potentially modifying the disease with a single intraarticular injection would be transformative for patients, physicians, and the healthcare system.” PCRX-201 features an innovative design based on the company’s proprietary high-capacity adenovirus, or HCAd, gene therapy vector platform. It is injected locally into the knee joint to boost cellular production of interleukin-1 receptor antagonist (IL-1Ra), and block interleukin-1 pathway activation to improve chronic inflammation, pain, and function. PCRX-201’s unique disease-modifying design also features an inducible promoter to mimic the body’s natural response to inflammation by “turning up” the expression of IL-1Ra when inflammation is present in the joint and turning down expression once inflammation is quelled. Study Details The open-label, Phase 1 trial investigated the safety and efficacy of PCRX-201 administered by ultrasound-guided intra-articular injection in 72 patients aged 30 to 80 who remained in the trial for 156 weeks. Participants were divided into two cohorts. The first cohort (N=36) was administered one injection of PCRX-201 at a low, middle or high dosage. The second cohort (N=36) received concurrent pretreatment with an intra-articular corticosteroid (methylprednisolone 40 mg) to improve tolerability and gene transfer. Knee pain, stiffness and function were assessed at 156 weeks using the Western Ontario and McMaster Universities Osteoarthritis Index pain score (WOMAC-A), the stiffness score (WOMAC-B), and the Knee Injury Osteoarthritis Outcome Score (KOOS), respectively. Key Findings: No serious treatment-emergent AEs related to the treatment or procedure were reported regardless of steroid pretreatment or dose level administered. Treatment-related joint effusions (swelling) were the most common AE, occurring in 36% of patients who received steroid pretreatment vs 61% of patients who were not pretreated. The majority of effusions were mild to moderate in severity and resolved in a median of 33 days among patients in the pretreated group. “PCRX-201 continues to show excellent results as a unique disease-modifying gene therapy for osteoarthritis, with the potential to transform how we manage this often-debilitating condition affecting millions of Americans,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “The three-year durability that we’ve seen so far continues to reinforce the importance of advancing PCRX-201 and potentially delivering innovative solutions to meet the longstanding unmet needs of patients living with osteoarthritis of the knee.” In March 2024, PCRX-201 became the first-ever gene therapy product candidate in osteoarthritis to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with the FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the Biologics License Application (BLA), and other opportunities to expedite development and review. PCRX-201 was also granted Advanced Therapy Medicinal Products (ATMP) designation by the European Medicines Agency in May 2023. Given the promising Phase 1 results, dosing is underway in a Phase 2 study of PCRX-201 (the ASCEND study) for the treatment of osteoarthritis of the knee. About PCRX-201 (enekinragene inzadenovec) PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today. In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee – a testament to its promise and potential. About Pacira Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL ® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera ® º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The Company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel, locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com . SOURCE: Pacira

Phase 1Clinical ResultGene TherapyDrug ApprovalPhase 2

11 Jun 2025

·www.globenewswire.com

Pacira BioSciences Unveils Three-Year Clinical Data Following a Single Local Administration of Investigational Gene Therapy, PCRX-201, in Patients with Moderate-to-Severe Osteoarthritis of the Knee

-- PCRX-201 demonstrated sustained clinical efficacy with improvements in pain, stiffness, and function for up to three years – BRISBANE, Calif., June 11, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced new long-term follow-up data from its Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a novel gene therapy candidate for osteoarthritis of the knee. Results show that a single intra-articular injection of PCRX-201 was well tolerated and produced sustained improvements in pain, stiffness, and function through 156 weeks in patients with moderate-to-severe osteoarthritis of the knee. The study findings will be presented during a poster session at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain, on Wednesday, June 11, from 3:30 to 4:30 PM CET. “The three-year data from this trial underscore the potential of PCRX-201 to meaningfully change the treatment paradigm for patients living with osteoarthritis of the knee,” said Philip G. Conaghan, Professor of Musculoskeletal Medicine at the University of Leeds and lead author on the study. “Current osteoarthritis treatments target its symptoms and are limited to three to six months of pain relief. With PCRX-201, we are targeting chronic inflammation at the cellular level to address a root cause of osteoarthritis. Providing three or more years of improvements in pain and function while potentially modifying the disease with a single intraarticular injection would be transformative for patients, physicians, and the healthcare system.” PCRX-201 features an innovative design based on the company’s proprietary high-capacity adenovirus, or HCAd, gene therapy vector platform. It is injected locally into the knee joint to boost cellular production of interleukin-1 receptor antagonist (IL-1Ra), and block interleukin-1 pathway activation to improve chronic inflammation, pain, and function. PCRX-201’s unique disease-modifying design also features an inducible promoter to mimic the body’s natural response to inflammation by “turning up” the expression of IL-1Ra when inflammation is present in the joint and turning down expression once inflammation is quelled. Study DetailsThe open-label, Phase 1 trial investigated the safety and efficacy of PCRX-201 administered by ultrasound-guided intra-articular injection in 72 patients aged 30 to 80 who remained in the trial for 156 weeks. Participants were divided into two cohorts. The first cohort (N=36) was administered one injection of PCRX-201 at a low, middle or high dosage. The second cohort (N=36) received concurrent pretreatment with an intra-articular corticosteroid (methylprednisolone 40 mg) to improve tolerability and gene transfer. Knee pain, stiffness and function were assessed at 156 weeks using the Western Ontario and McMaster Universities Osteoarthritis Index pain score (WOMAC-A), the stiffness score (WOMAC-B), and the Knee Injury Osteoarthritis Outcome Score (KOOS), respectively. Key Findings: A single injection of PCRX-201 at any dose level had an acceptable safety profile and was not associated with any serious treatment-related adverse events.Patients experienced sustained, clinically meaningful reductions in pain and stiffness and improvements in function for three years.Least squares mean (LSM) improvements from baseline in the corticosteroid-pretreated cohort across all PCRX-201 doses included: 51–53% reduction in WOMAC-A pain scores38–76% reduction in WOMAC-B stiffness scores26–28-point improvements in KOOS daily living function scores The findings suggest lower doses of PCRX-201 may be effective and support ongoing investigation in Phase 2 studies. No serious treatment-emergent AEs related to the treatment or procedure were reported regardless of steroid pretreatment or dose level administered. Treatment-related joint effusions (swelling) were the most common AE, occurring in 36% of patients who received steroid pretreatment vs 61% of patients who were not pretreated. The majority of effusions were mild to moderate in severity and resolved in a median of 33 days among patients in the pretreated group. “PCRX-201 continues to show excellent results as a unique disease-modifying gene therapy for osteoarthritis, with the potential to transform how we manage this often-debilitating condition affecting millions of Americans,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “The three-year durability that we’ve seen so far continues to reinforce the importance of advancing PCRX-201 and potentially delivering innovative solutions to meet the longstanding unmet needs of patients living with osteoarthritis of the knee.” In March 2024, PCRX-201 became the first-ever gene therapy product candidate in osteoarthritis to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with the FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the Biologics License Application (BLA), and other opportunities to expedite development and review. PCRX-201 was also granted Advanced Therapy Medicinal Products (ATMP) designation by the European Medicines Agency in May 2023. Given the promising Phase 1 results, dosing is underway in a Phase 2 study of PCRX-201 (the ASCEND study) for the treatment of osteoarthritis of the knee. About PCRX-201 (enekinragene inzadenovec)PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today. In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee – a testament to its promise and potential. About PaciraPacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The Company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel, locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com. Forward-Looking StatementsAny statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: the settlement described herein, ‘5x30’, our growth and business strategy; our future outlook, our intellectual property and patent terms, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances and other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the acquired businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company; the anticipated funding or benefits of our share repurchase program; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the “SEC”). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these statements. These factors include the matters discussed and referenced in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the SEC. Investor Contact: Susan Mesco, (973) 451-4030 susan.mesco@pacira.com Media Contact: Sara Marino, (973) 370-5430 sara.marino@pacira.com

Clinical ResultPhase 1Phase 2Gene Therapy

15 May 2025

·www.globenewswire.com

Pacira BioSciences Presents New Data on the Effects of Clinical Immunogenicity on Locally Administered PCRX-201 in Patients with Moderate to Severe Osteoarthritis of the Knee

-- Early clinical data indicates that Pre-existing and treatment-induced anti-Ad5 neutralizing antibodies do not impact the safety and effectiveness of PCRX-201 – -- An oral presentation of the data to be featured at the ASGCT Annual Meeting -- BRISBANE, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced new preliminary data which suggests that clinical immunogenicity does not reduce sustained improvements in knee pain, stiffness and function provided by its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), following local administration in patients with mild, moderate, as well as severe osteoarthritis of the knee. The research findings are being presented during a podium session at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in New Orleans on May 15, 2025, at 2:15 CT. “These are encouraging results supporting the potential of PCRX-201 as an effective and durable treatment option for patients with osteoarthritis of the knee, many of whom currently rely on therapies that deliver only short-term, limited relief,” said Mijeong Kim, immunology and pharmacology leader at Pacira BioSciences and lead investigator of the research. “Natural immune responses are a major obstacle for gene therapies, since they can hinder the effectiveness of the treatment and increase adverse reactions. This preliminary data indicates that neither pre-existing nor treatment-induced immunogenicity compromise the safety or long-lasting efficacy of PCRX-201.” PCRX-201 features an innovative design based on the company’s proprietary high-capacity adenovirus, or HCAd, gene therapy vector platform. The HCAd vector is based on adenovirus serotype 5 (Ad5), a well understood serotype that is very common in community circulation. PCRX-201 is injected locally into the knee joint to boost cellular production of interleukin-1 receptor antagonist (IL-1Ra) and block interleukin-1 pathway activation to improve chronic inflammation, pain, and function. PCRX-201’s unique design also features an inducible promoter to mimic the body’s natural response to inflammation by “turning on” the expression of IL-1Ra when inflammation is present in the joint and turning off expression once inflammation is quelled. Study DetailsThe open-label, phase 1 trial evaluated the effect that pre-existing or treatment-induced anti-Ad5 neutralizing antibodies (NAbs) have on PCRX-201 and its impact on dosing and redosing strategy. The study enrolled 72 participants aged 30 to 80 who received a single low, middle or high dose of PCRX-201. One of the two study cohorts (N=36) was pretreated with an intraarticular corticosteroid (methylprednisolone 40 mg) prior to the PCRX-201 injection. The presence of NAb titers in patients’ blood and synovial fluid (SF), as well as the levels of IL-1Ra in SF, were measured over 52 weeks. The data indicates that pre-existing NAbs did not affect the efficacy or safety of PCRX-201 at any of the three doses studied. All doses achieved improved pain, stiffness and function as measured by WOMAC-A and WOMAC-B (The Western Ontario and McMaster Universities Osteoarthritis Index). The findings also demonstrated that using a corticosteroid treatment before PCRX-201 administration appears to help reduce treatment-induced NAb titers and dose-related swelling of the knee joint. Additionally, most serum NAb titers fell below the highest observed baseline levels within 38 to 52 weeks. No serious treatment-emergent AEs related to the treatment or procedure were reported regardless of steroid pretreatment or dose level administered. Treatment-related joint effusions (swelling) were the most common AE, occurring in 36% of patients who received steroid pretreatment vs 61% of patients who were not pretreated. The majority of effusions were mild to moderate in severity and resolved in a median of 33 days among patients in the pretreated group. “Advancing gene therapy as an approach to treating pain is a natural progression of Pacira’s deep commitment to innovation in non-opioid therapies and delivers on our 5x30 strategy for growth and value creation,” said Frank D. Lee, chief executive officer of Pacira Biosciences. “With our Phase 2 study of PCRX-201 currently underway, we see great potential for offering a long-lasting pain relief option to the 14 million patients living with osteoarthritis of the knee, an often debilitating condition that can severely impact mobility and quality of life.” In March 2024, PCRX-201 became the first-ever gene therapy product candidate in osteoarthritis to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with the FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the Biologics License Application (BLA), and other opportunities to expedite development and review. PCRX-201 was also granted Advanced Therapy Medicinal Products (ATMP) designation by the European Medicines Agency in May 2023. Given the promising Phase 1 results, dosing is underway in a Phase 2 study of PCRX-201 (the ASCEND study) for the treatment of osteoarthritis of the knee. About PCRX-201 (enekinragene inzadenovec)PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today. In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee – a testament to its promise and potential. About PaciraPacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The Company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel, locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com. Forward-Looking StatementsAny statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: the settlement described herein, ‘5x30’, our growth and business strategy; our future outlook, our intellectual property and patent terms, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances and other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the acquired businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company; the anticipated funding or benefits of our share repurchase program; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the “SEC”). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these statements. These factors include the matters discussed and referenced in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the SEC. Investor Contact: Susan Mesco, (973) 451-4030 susan.mesco@pacira.com Media Contact: Sara Marino, (973) 370-5430 sara.marino@pacira.com

Phase 1Clinical ResultGene TherapyPhase 2

100 Deals associated with Bupivacaine liposome

External Link

KEGG	Wiki	ATC	Drug Bank
D07552	Bupivacaine liposome	N01BB01	DB00297

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain, Postoperative	United States	Pacira Biosciences, Inc.	28 Oct 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Back Pain	Phase 3	United States	Pacira Biosciences, Inc.	30 Apr 2024
Pain	Phase 3	United States	Pacira Biosciences, Inc.	22 Oct 2021
Analgesia	Phase 3	United States	Pacira Biosciences, Inc.	14 Apr 2021
Leg Injuries	Phase 3	United States	Pacira Biosciences, Inc.	20 Oct 2020
Female Genital Neoplasms	Phase 3	United States	Pacira Biosciences, Inc.	31 Aug 2016
Brachial Plexus Neuritis	Phase 3	United States	Pacira Biosciences, Inc.	09 May 2016
Brachial Plexus Neuritis	Phase 3	Belgium	Pacira Biosciences, Inc.	09 May 2016
Brachial Plexus Neuritis	Phase 3	Denmark	Pacira Biosciences, Inc.	09 May 2016
Toothache	Phase 3	United States	Pacira Biosciences, Inc.	01 Aug 2015
Bunion	Phase 3	United States	Pacira Biosciences, Inc.	01 Apr 2009

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04559347 (CTgov)	Phase 2	Thoracic Diseases	45	Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine)	mimuzxypps(scbuiowiaw) = fyfnqvlory pmvbuyomui (vocgmwjzrt, 2.531) View more	-	12 Jun 2025
				Ropivacaine (Continuous Catheter Infusion Ropivacaine)	mimuzxypps(scbuiowiaw) = mevcgeebfe pmvbuyomui (vocgmwjzrt, 2.744) View more
NCT05537883 (TAP, CTgov)	Phase 1	Obesity, Morbid	72	Bupivacaine Injection (Bupivacaine Only)	ygumbthfhr(wqvcgycodr) = mrooysgnzh hhnatwaxyd (qlrkvxetuh, irooakezqc - gabfadmfea) View more	-	11 Jun 2025
				Liposomal bupivacaine (Liposomal Bupivacaine)	ygumbthfhr(wqvcgycodr) = mwnrfzyujj hhnatwaxyd (qlrkvxetuh, rbqvlxobpj - vkwatgitbx) View more
NCT04685876 (CLEVELAND, CTgov)	Phase 3	-	285	Liposomal bupivacaine (Liposomal Bupivacaine)	xvawdcfqny(hsnblxltci) = emmglppzos womyagbkmn (oxkekmpomq, cbhylybqtk - siddpyonwy) View more	-	07 May 2025
				Plain bupivacaine (Plain Bupivacaine)	xvawdcfqny(hsnblxltci) = cvxkxyooql womyagbkmn (oxkekmpomq, qqjraojjlm - qfoznfbvwh) View more
NCT03290196 (CTgov)	Phase 4	Pain, Postoperative \| Rotator Cuff Tear Arthropathy	13	EXPAREL	bgulnrvndb(xoovflcrja) = hrydsggkli uivinppgoj (bejpzriqlz, 3.0) View more	-	30 Mar 2025
NCT04393207 (CTgov)	Phase 4	Analgesia \| Acute Pain	147	Bupivacaine (Control Group (Bupivacaine))	looeigvcxg(ehrcekdgle) = noqiwjwyij zfthgdfxga (jjmldxnfuf, 8.12) View more	-	21 Mar 2025
				methylprednisolone+Liposomal bupivacaine (LB)+Dexamethasone (Liposomal Bupivacaine)	looeigvcxg(ehrcekdgle) = jwggokkjks zfthgdfxga (jjmldxnfuf, 10.16) View more
NCT04300231 (CTgov)	Phase 3	Pain, Postoperative	160	/hydromorphone 0.05mg/ml+bupivacaine (Thoracic Epidural)	ntemmnkrgv(xulslsjdod) = uspsxgbehf vzqmlcnifh (rrmuimenzf, lazjuftjzc - luxequqdlb) View more	-	10 Feb 2025
				injectable saline+Liposomal bupivacaine+bupivacaine (Rectus Sheath Block)	ntemmnkrgv(xulslsjdod) = jytlgpllsq vzqmlcnifh (rrmuimenzf, dyrwjhsmuo - duxduktnzw) View more
NCT04928339 (CTgov)	Phase 4	-	100	Liposomal bupivacaine+Bupivacaine Injection (PIFB Intervention)	fshohxjvug(vhhednexui) = vtldzuvyqp jdpkjxseua (ufdgwwujqq, uvpobwcmoc - fktipruvzk) View more	-	19 Nov 2024
				Saline (Saline Control)	fshohxjvug(vhhednexui) = hwewzlbajq jdpkjxseua (ufdgwwujqq, ctaeksoidq - hahmqxeowm) View more
NCT05139030 (CTgov)	Phase 3	Pain, Postoperative	167	EXPAREL (Cohort 1 + 2 EXPAREL ADMIX ARM)	sewiittwiz(aliteznbdk) = uufzsdgjnc fitrvhwdex (vvzzzemdbm, 191.65) View more	-	24 Oct 2024
				BUPIVACAINE (Cohort 1 + 2 BUPIVACAINE HCI ARM)	sewiittwiz(aliteznbdk) = jwwwgksofb fitrvhwdex (vvzzzemdbm, 178.95) View more
NCT04258631 (CTgov)	Phase 4	Female Genital Neoplasms \| Pain	105	Laparotomy+Liposomal Bupivacaine (Arm I (Laparotomy, Liposomal Bupivacaine))	xxbzlvnfup(evawikggyr) = ixogrepruo rvtfyhewsn (wkgpznbple, zkrxpfuqny - zkvhmwhlqz) View more	-	16 Oct 2024
				Laparotomy+Hydromorphone+Liposomal Bupivacaine (Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone))	xxbzlvnfup(evawikggyr) = zrxdugbmwb rvtfyhewsn (wkgpznbple, olvlnlbbhh - dfitdlgbsc) View more
NCT04777591 (CTgov)	Phase 4	Pain, Postoperative	117	Bupivacain (Control - Plain Bupivacaine)	jxxbvvbvxz(yjzwyljrmq) = zjffzjfffp vfhuyklaql (qumvpmnhee, abslvjbcyz - pxhbtfjytg) View more	-	23 Aug 2024
				Liposomal bupivacaine TAP block+bupivacain (Experimental - Liposomal Bupivacaine)	jxxbvvbvxz(yjzwyljrmq) = pspekfnqcc vfhuyklaql (qumvpmnhee, mdqibsydjy - wxyjbigtds) View more

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