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.

开始日期2025-07-01

申办/合作机构

香港大学

NCT06995352

/ Not yet recruiting临床4期IIT

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.

开始日期2025-06-15

申办/合作机构

University of California San Diego

[+1]

NCT06942689

/ Recruiting临床4期IIT

Determination of the Optimal Volume of Liposomal Bupivacaine in Single-Shot Adductor Canal Block for Knee Joint Surgery-A Phase I/II Trial

Building on Bayesian design methodologies from volume optimization studies of ropivacaine in shoulder surgery, this study pioneers the application of a seamless dose-finding strategy in knee ACB. Utilizing advanced statistical models (BOIN/BOP2 design), we aim to systematically evaluate the volume-effect relationship of liposomal bupivacaine, providing precise dosing recommendations to advance personalized and optimized analgesic protocols for knee surgery.

开始日期2025-06-01

申办/合作机构-

100 项与布比卡因脂质体相关的临床结果

登录后查看更多信息

100 项与布比卡因脂质体相关的转化医学

登录后查看更多信息

100 项与布比卡因脂质体相关的专利（医药）

登录后查看更多信息

801

项与布比卡因脂质体相关的文献（医药）

2025-12-31·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

作者: Heath, Steven ; Zirath, Richa ; Beins, Michael ; Pal, Sarmistha ; 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.

2025-08-01·Journal of Vascular Surgery Cases Innovations and Techniques

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

Article

作者: 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.

2025-08-01·PEDIATRIC TRANSPLANTATION

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

Article

作者: 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.

108

项与布比卡因脂质体相关的新闻（医药）

2025-06-12

·PipelineReview

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

临床1期临床结果基因疗法上市批准临床2期

2025-06-11

·GlobeNewswire-Health Care

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

临床结果临床1期临床2期基因疗法

2025-06-08

·信狐药迅

浙江杭煜1类新药索美来昔、三生国健IL-1β单抗提交上市申请|新受理（6.2-6.8）

本周药品注册受理数据，分门别类呈现，一目了然。(6.2-6.8）新药上市申请药品名称企业注册分类受理号硫酸索美来昔片浙江杭煜制药有限公司1CXHS2500061赖诺普利氨氯地平片四川尚锐生物医药有限公司2.4CXHS2500062呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS2500060呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS250005915价肺炎球菌结合疫苗北京智飞绿竹生物制药有限公司2.1CXSS2500059重组抗IL-1β人源化单克隆抗体注射液三生国健药业(上海)股份有限公司1CXSS2500060注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.2CXSS2500058新药临床申请药品名称企业注册分类受理号注射用HTMC0769上海壹典医药科技开发有限公司1CXHL2500546HSK47977片海思科医药集团股份有限公司1CXHL2500545HSK47977片海思科医药集团股份有限公司1CXHL2500544WJ22096片南京境奥生物医药科技有限公司1CXHL2500543WJ22096片南京境奥生物医药科技有限公司1CXHL2500542HRS-4508片江苏恒瑞医药股份有限公司1CXHL2500541HRS-4508片江苏恒瑞医药股份有限公司1CXHL2500540QL-H118片南京芩领医药科技有限公司1CXHL2500538MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司1CXHL2500531MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司1CXHL2500530HB5凝胶北京中科先行医疗科技有限公司1CXHL2500536HB5凝胶北京中科先行医疗科技有限公司1CXHL2500535HB5凝胶北京中科先行医疗科技有限公司1CXHL2500534XC2309注射液浙江医药股份有限公司新昌制药厂1CXHL2500533D-2570片益方生物科技(上海)股份有限公司1CXHL2500529SN007干混悬剂上海惠永制药有限公司2.2CXHL2500539注射用硼[10B]法仑中子科学(重庆)研究院有限公司2.2CXHL2500532ZK062南京正科医药股份有限公司2.2CXHL2500528注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500537注射用SSS50沈阳三生制药有限责任公司1CXSL2500458注射用LM-24C5礼新医药科技(上海)有限公司1CXSL2500457HJY-ATRQβ-001注射液武汉华纪元生物技术开发有限公司1CXSL2500463注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2500455UC101 CAR-T细胞注射液成都优赛诺生物科技有限公司1CXSL2500451LYN101注射液上海才致药成生物科技有限公司1CXSL2500456TI-0093注射液圆因(北京)生物科技有限公司1CXSL2500461KM1溶瘤痘苗病毒注射液深圳市华药康明生物药业有限责任公司1CXSL2500446SIBP-A10注射液上海生物制品研究所有限责任公司1CXSL2500449注射用DXC018杭州多禧生物科技有限公司1CXSL2500444替雷利珠单抗注射液广州百济神州生物制药有限公司2.1CXSL2500447贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500450阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500448司普奇拜单抗注射液成都康诺行生物医药科技有限公司2.2CXSL2500454仿制药申请药品名称企业注册分类受理号盐酸异丙肾上腺素注射液江苏迪赛诺制药有限公司3CYHS2502023盐酸异丙肾上腺素注射液江苏迪赛诺制药有限公司3CYHS2502022叶酸注射液北京远方通达医药技术有限公司3CYHS2502020叶酸注射液北京远方通达医药技术有限公司3CYHS2502019比拉斯汀口服溶液嘉亨(珠海横琴)医药科技有限公司3CYHS2502018盐酸溴己新口服溶液湖南九典制药股份有限公司3CYHS2502016维生素K1注射液成都苑东生物制药股份有限公司3CYHS2502012硝普钠注射液河北一品制药股份有限公司3CYHS2502011碳酸司维拉姆干混悬剂山东百诺医药股份有限公司3CYHS2502009乙酰半胱氨酸片江西迪赛诺医药集团有限公司3CYHS2502008唑来膦酸注射液广东大翔制药有限公司3CYHS2502005米诺地尔搽剂山东朗诺制药有限公司3CYHS2502003米诺地尔搽剂山东朗诺制药有限公司3CYHS2502002西格列汀二甲双胍缓释片寿光富康制药有限公司3CYHS2501999多种微量元素注射液(I)成都欣捷高新技术开发股份有限公司3CYHS2501992联苯苄唑溶液浙江致新医药科技有限公司3CYHS2501987对乙酰氨基酚布洛芬片哈尔滨三联药业股份有限公司3CYHS2501980注射用头孢噻肟钠/氯化钠注射液湖南科伦制药有限公司3CYHS2501998注射用头孢噻肟钠/氯化钠注射液湖南科伦制药有限公司3CYHS2501997硝普钠注射液山东齐都药业有限公司3CYHS2501982硝普钠注射液山东齐都药业有限公司3CYHS2501981注射用氢化可的松琥珀酸钠沐源(安徽)药业有限公司3CYHS2501975注射用氢化可的松琥珀酸钠沐源(安徽)药业有限公司3CYHS2501974吡格列酮二甲双胍片浙江众延医药科技有限公司3CYHS2501972碳酸司维拉姆干混悬剂福建博悦医药科技有限公司3CYHS2501966米诺地尔搽剂江苏福邦药业有限公司3CYHS2501965布比卡因脂质体注射液浙江海昶生物医药技术有限公司3CYHS2501973枸橼酸托法替布缓释片北大医药股份有限公司4CYHS2502027恩格列净片德州博诚制药有限公司4CYHS2502026恩格列净片德州博诚制药有限公司4CYHS2502025氧韩城市红光制气有限责任公司4CYHS2502024玻璃酸钠滴眼液广州大光制药有限公司4CYHS2502021甲钴胺片河北宏鑫堂药业有限公司4CYHS2502017磷酸奥司他韦胶囊石家庄四药有限公司4CYHS2502015磷酸奥司他韦胶囊石家庄四药有限公司4CYHS2502014乙酰半胱氨酸注射液舒美奇成都生物科技有限公司4CYHS2502013硫酸氨基葡萄糖胶囊山东百诺医药股份有限公司4CYHS2502010利那洛肽胶囊苏州二叶制药有限公司4CYHS2502007唑来膦酸注射液广东大翔制药有限公司4CYHS2502006盐酸氨溴索注射液中国大冢制药有限公司4CYHS2502004地拉罗司分散片河北天成药业股份有限公司4CYHS2502001乙酰半胱氨酸注射液浙江昂利康制药股份有限公司4CYHS2502000盐酸羟考酮缓释片江苏恩华药业股份有限公司4CYHS2501993二十碳五烯酸乙酯软胶囊北京斯利安药业有限公司4CYHS2501995佩玛贝特片南京海鲸药业股份有限公司4CYHS2501994依折麦布阿托伐他汀钙片(I)华润赛科药业有限责任公司4CYHS2501991依折麦布阿托伐他汀钙片(II)华润赛科药业有限责任公司4CYHS2501990甲磺酸沙非胺片宁波美诺华天康药业有限公司4CYHS2501989甲磺酸沙非胺片宁波美诺华天康药业有限公司4CYHS2501988棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂4CYHS2501986棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂4CYHS2501985棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂4CYHS2501984依西美坦片浙江亚瑟医药有限公司4CYHS2501983非洛地平缓释片河北爱普制药有限公司4CYHS2501996乙酰半胱氨酸注射液西藏诺泽生物医药有限公司4CYHS2501979左氧氟沙星滴眼液合肥华威药业有限公司4CYHS2501971盐酸氨溴索口服溶液广东南国药业有限公司4CYHS2501970盐酸氨溴索口服溶液广东南国药业有限公司4CYHS2501969阿达帕林过氧苯甲酰凝胶北京普祺医药科技股份有限公司4CYHS2501968阿达帕林过氧苯甲酰凝胶北京普祺医药科技股份有限公司4CYHS2501967他达拉非片浙江永太药业有限公司4CYHS2501964他达拉非片浙江永太药业有限公司4CYHS2501963尼可地尔片国药集团容生制药有限公司4CYHS2501962甲磺酸沙非胺片成都明德至远医药科技有限公司4CYHS2501961甲磺酸沙非胺片成都明德至远医药科技有限公司4CYHS2501960达格列净片重庆科瑞南海制药有限责任公司4CYHS2501959达格列净片重庆科瑞南海制药有限责任公司4CYHS2501958达格列净片合肥合源药业有限公司4CYHS2501978达格列净片合肥合源药业有限公司4CYHS2501977甲磺酸贝舒地尔片浙江华义制药有限公司4CYHS2501976盐酸毛果芸香碱滴眼液浙江莎普健康管理有限公司3CYHL2500107维生素D口服溶液厦门紫旭医药科技有限公司3CYHL2500105利多卡因丙胺卡因牙周凝胶深圳珐玛易药品科技有限公司3CYHL2500103布地奈德福莫特罗吸入粉雾剂(II)珠海瑞思普利医药科技有限公司4CYHL2500106多种油脂肪乳注射液(C6-24)成都国为生物医药有限公司4CYHL2500104流感病毒裂解疫苗武汉生物制品研究所有限责任公司3.3CXSL2500460流感病毒裂解疫苗武汉生物制品研究所有限责任公司3.3CXSL2500459度普利尤单抗注射液石药集团巨石生物制药有限公司3.3CXSL2500453度普利尤单抗注射液石药集团巨石生物制药有限公司3.3CXSL2500452SAL023注射液信立泰(苏州)药业有限公司3.3CXSL2500445进口申请药品名称企业注册分类受理号替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2500064替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2500063替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2500062替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2500061Clesrovimab注射液Merck Sharp & Dohme B.V.1JXSS2500071帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500073帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500072Quabodepistat片Otsuka Pharmaceutical Co., Ltd.1JXHL2500130JSB462片Novartis Pharma AG1JXHL2500129JSB462片Novartis Pharma AG1JXHL2500128TAR-210Janssen Research & Development, LLC2.2;2.4JXHL2500125镥(177Lu)vipivotide tetraxetan注射液Novartis Pharma AG2.4JXHL2500127BMS-986165片Bristol-Myers Squibb Company2.4JXHL2500124BMS-986165片Bristol-Myers Squibb Company2.4JXHL2500123用于制备放射性药物镓(68Ga)gozetotide注射液的药盒Novartis Europharm Limited5.1JXHL2500126中药相关申请药品名称企业注册分类受理号益胃消瘀颗粒重庆市中药研究院(重庆市中药博物馆)1.1CXZL2500037复方黄杞颗粒浙江九如医药科技有限公司1.1CXZL2500036黄厚止泻滴丸安徽雷允上药业有限公司2.3CXZL2500035苓桂术甘颗粒神威药业集团有限公司3.1CXZS2500024注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市疫苗临床申请

100 项与布比卡因脂质体相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D07552	布比卡因脂质体	N01BB01	DB00297

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
术后疼痛	美国	Pacira Biosciences, Inc.	2011-10-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
背痛	临床3期	美国	Pacira Biosciences, Inc.	2024-04-30
疼痛	临床3期	美国	Pacira Biosciences, Inc.	2021-10-22
镇痛	临床3期	美国	Pacira Biosciences, Inc.	2021-04-14
腿损伤	临床3期	美国	Pacira Biosciences, Inc.	2020-10-20
女性生殖器官肿瘤	临床3期	美国	Pacira Biosciences, Inc.	2016-08-31
臂丛神经炎	临床3期	美国	Pacira Biosciences, Inc.	2016-05-09
臂丛神经炎	临床3期	比利时	Pacira Biosciences, Inc.	2016-05-09
臂丛神经炎	临床3期	丹麦	Pacira Biosciences, Inc.	2016-05-09
牙痛	临床3期	美国	Pacira Biosciences, Inc.	2015-08-01
拇囊炎	临床3期	美国	Pacira Biosciences, Inc.	2009-04-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04559347 (CTgov)	临床2期	胸部疾病	45	Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine)	願簾獵糧願膚簾憲艱鏇(積築艱蓋製艱鑰廠網糧) = 簾願鑰製膚鬱齋廠獵簾積憲觸衊築糧廠製鏇築 (鏇築壓壓顧鹽簾夢艱簾, 2.531) 更多	-	2025-06-12
				Ropivacaine (Continuous Catheter Infusion Ropivacaine)	願簾獵糧願膚簾憲艱鏇(積築艱蓋製艱鑰廠網糧) = 艱範窪網鹽鹹顧夢獵憲積憲觸衊築糧廠製鏇築 (鏇築壓壓顧鹽簾夢艱簾, 2.744) 更多
NCT05537883 (TAP, CTgov)	临床1期	病态肥胖	72	Bupivacaine Injection (Bupivacaine Only)	積簾鏇憲顧壓廠鏇鹽網(網範積鑰餘鏇衊選選選) = 膚窪鑰齋壓廠憲遞窪蓋艱衊鏇網餘餘積襯憲襯 (製網膚築壓遞觸鹹築積, 簾醖窪獵鑰蓋簾廠願窪 ~ 膚範選獵窪選糧壓鑰襯) 更多	-	2025-06-11
				Liposomal bupivacaine (Liposomal Bupivacaine)	積簾鏇憲顧壓廠鏇鹽網(網範積鑰餘鏇衊選選選) = 醖餘齋醖顧構齋製獵鹹艱衊鏇網餘餘積襯憲襯 (製網膚築壓遞觸鹹築積, 窪淵範憲鏇選糧衊襯網 ~ 憲餘窪繭製憲構顧糧窪) 更多
NCT04685876 (CLEVELAND, CTgov)	临床3期	-	285	Liposomal bupivacaine (Liposomal Bupivacaine)	夢窪襯顧觸淵艱窪壓壓(淵蓋簾範醖製壓膚齋構) = 憲築簾遞鏇鹽鬱顧襯糧蓋觸襯齋醖艱蓋憲餘夢 (簾願廠淵夢顧淵醖鹽願, 簾範淵壓構膚醖繭遞蓋 ~ 製齋遞願壓艱構觸衊顧) 更多	-	2025-05-07
				Plain bupivacaine (Plain Bupivacaine)	夢窪襯顧觸淵艱窪壓壓(淵蓋簾範醖製壓膚齋構) = 獵淵餘壓製簾範衊廠餘蓋觸襯齋醖艱蓋憲餘夢 (簾願廠淵夢顧淵醖鹽願, 構構醖齋壓鹽遞觸壓糧 ~ 齋廠範鹽淵選醖築構遞) 更多
NCT03290196 (CTgov)	临床4期	术后疼痛 \| 肩袖撕裂关节病	13	EXPAREL	鹹獵壓獵遞築鹹膚膚築(齋積遞醖糧壓蓋艱膚願) = 築積獵齋鹹廠製願糧繭鬱糧選淵餘願鏇範鑰觸 (築襯憲窪壓夢製蓋鏇衊, 3.0) 更多	-	2025-03-30
NCT04393207 (CTgov)	临床4期	镇痛 \| 急性疼痛	147	Bupivacaine (Control Group (Bupivacaine))	願壓製衊遞襯糧構顧襯(鑰膚網醖構構糧鑰構顧) = 衊遞觸觸遞簾簾鬱壓膚簾壓構壓壓膚顧膚糧鬱 (艱蓋壓糧窪膚簾鬱廠顧, 8.12) 更多	-	2025-03-21
				methylprednisolone+Liposomal bupivacaine (LB)+Dexamethasone (Liposomal Bupivacaine)	願壓製衊遞襯糧構顧襯(鑰膚網醖構構糧鑰構顧) = 夢簾獵廠憲蓋蓋遞顧窪簾壓構壓壓膚顧膚糧鬱 (艱蓋壓糧窪膚簾鬱廠顧, 10.16) 更多
NCT04300231 (CTgov)	临床3期	术后疼痛	160	/hydromorphone 0.05mg/ml+bupivacaine (Thoracic Epidural)	襯憲鑰蓋鏇糧鹽廠夢衊(獵壓憲廠壓廠製製廠窪) = 夢壓醖願構襯遞醖鬱襯遞艱鬱窪範廠範襯網選 (窪製築製觸襯網衊艱鹹, 鑰醖觸鹽齋遞醖蓋壓繭 ~ 衊艱糧膚壓網遞顧構蓋) 更多	-	2025-02-10
				injectable saline+Liposomal bupivacaine+bupivacaine (Rectus Sheath Block)	襯憲鑰蓋鏇糧鹽廠夢衊(獵壓憲廠壓廠製製廠窪) = 積顧選網鑰衊積鏇齋願遞艱鬱窪範廠範襯網選 (窪製築製觸襯網衊艱鹹, 構餘夢製廠醖衊齋蓋繭 ~ 觸鑰壓願鹹蓋醖鏇遞範) 更多
NCT04928339 (CTgov)	临床4期	-	100	Liposomal bupivacaine+Bupivacaine Injection (PIFB Intervention)	襯簾積齋遞鹽窪選蓋餘(膚衊壓蓋鹽鏇夢觸鬱糧) = 願糧齋願鏇齋選膚窪獵繭築衊願憲膚選選獵襯 (廠範憲築積鹽廠淵鹹選, 窪構齋鹹蓋遞齋遞鬱獵 ~ 願築鏇糧膚醖鑰製餘簾) 更多	-	2024-11-19
				Saline (Saline Control)	襯簾積齋遞鹽窪選蓋餘(膚衊壓蓋鹽鏇夢觸鬱糧) = 觸觸構鏇衊鹽觸衊壓鹽繭築衊願憲膚選選獵襯 (廠範憲築積鹽廠淵鹹選, 觸選鹽齋觸鬱遞選夢糧 ~ 顧製顧構艱簾廠鏇醖網) 更多
NCT05139030 (CTgov)	临床3期	术后疼痛	167	EXPAREL (Cohort 1 + 2 EXPAREL ADMIX ARM)	壓蓋構願夢蓋艱鹹選繭(齋鹹遞衊廠鬱鹽艱壓積) = 築鬱積蓋衊構構艱網艱簾醖觸壓壓顧獵憲鏇鬱 (鹹齋願遞簾窪簾鏇積窪, 191.65) 更多	-	2024-10-24
				BUPIVACAINE (Cohort 1 + 2 BUPIVACAINE HCI ARM)	壓蓋構願夢蓋艱鹹選繭(齋鹹遞衊廠鬱鹽艱壓積) = 襯獵壓顧糧窪積鹽憲遞簾醖觸壓壓顧獵憲鏇鬱 (鹹齋願遞簾窪簾鏇積窪, 178.95) 更多
NCT04258631 (CTgov)	临床4期	女性生殖器官肿瘤 \| 疼痛	105	Laparotomy+Liposomal Bupivacaine (Arm I (Laparotomy, Liposomal Bupivacaine))	壓顧繭願鬱範鹹積襯鹹(構憲積廠齋糧膚憲獵齋) = 膚鏇選獵網範鏇繭構膚顧繭選鏇顧範壓醖選壓 (鑰衊淵顧廠構鏇積憲襯, 艱憲選鹹鑰鹽憲窪膚範 ~ 襯構襯顧願觸醖鬱範網) 更多	-	2024-10-16
				Laparotomy+Hydromorphone+Liposomal Bupivacaine (Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone))	壓顧繭願鬱範鹹積襯鹹(構憲積廠齋糧膚憲獵齋) = 願顧餘餘鏇壓觸壓壓積顧繭選鏇顧範壓醖選壓 (鑰衊淵顧廠構鏇積憲襯, 廠憲製餘築淵艱艱築鹹 ~ 蓋淵觸獵鏇襯製鏇鬱鹹) 更多
NCT04777591 (CTgov)	临床4期	术后疼痛	117	Bupivacain (Control - Plain Bupivacaine)	窪艱築願繭網遞網襯襯(獵遞襯齋網網壓網鹹餘) = 鹽構範鹹廠餘網艱壓淵齋窪網壓選製鏇鹹鹽積 (網願襯獵鏇繭醖鹽鏇鹽, 淵淵鏇構衊齋夢鬱製積 ~ 網鏇築鹹膚醖範鏇構襯) 更多	-	2024-08-23
				Liposomal bupivacaine TAP block+bupivacain (Experimental - Liposomal Bupivacaine)	窪艱築願繭網遞網襯襯(獵遞襯齋網網壓網鹹餘) = 蓋獵窪膚鑰鏇鏇遞遞醖齋窪網壓選製鏇鹹鹽積 (網願襯獵鏇繭醖鹽鏇鹽, 遞夢衊構鏇襯糧廠製衊 ~ 餘繭網範艱鬱艱夢鹽繭) 更多