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Pacira BioSciences Announces Strategic Collaboration to Significantly Expand ZILRETTA Promotional Efforts
Globenewswire· 2025-07-22 12:00
Core Insights - Pacira BioSciences has announced a strategic collaboration with Johnson & Johnson MedTech to enhance the market reach of ZILRETTA, an extended-release treatment for osteoarthritis knee pain, by leveraging Johnson & Johnson's specialized sales force [1][2] - The partnership aims to significantly increase ZILRETTA sales calls and expand patient access, targeting a substantial portion of the seven million intra-articular knee injections administered annually in the U.S. [1][3] Company Overview - Pacira BioSciences specializes in innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera° [4] - ZILRETTA is the first and only extended-release intra-articular therapy approved by the FDA for osteoarthritis-related knee pain, utilizing proprietary microsphere technology for prolonged pain relief [5] Strategic Collaboration Details - The collaboration with Johnson & Johnson MedTech will enhance promotional efforts and extend ZILRETTA's reach beyond orthopedic practices into other specialties such as sports medicine, pain management, and rheumatology [3] - This partnership is part of Pacira's "5x30 strategy," which focuses on leveraging targeted collaborations to drive growth and improve patient outcomes with non-opioid treatments [2]
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
Globenewswire· 2025-05-15 12:00
Core Insights - Preliminary data indicates that pre-existing and treatment-induced anti-Ad5 neutralizing antibodies do not affect the safety and effectiveness of PCRX-201 for knee osteoarthritis [1][2][4] - The findings will be presented at the ASGCT Annual Meeting, highlighting the potential of PCRX-201 as a durable treatment option for knee osteoarthritis [1][2] Company Overview - Pacira BioSciences, Inc. is focused on innovative, non-opioid pain therapies, with PCRX-201 being a key candidate for treating knee osteoarthritis [1][11] - The company has received RMAT designation from the FDA for PCRX-201, which facilitates efficient drug development and potential accelerated approval [6][7][10] Study Details - An open-label, phase 1 trial involved 72 participants aged 30 to 80, assessing the impact of anti-Ad5 neutralizing antibodies on PCRX-201 [3] - The study measured NAb titers and IL-1Ra levels over 52 weeks, with results showing no adverse effects on efficacy or safety across different dosing levels [4][5] Treatment Efficacy - All doses of PCRX-201 led to improvements in knee pain, stiffness, and function, as measured by WOMAC-A and WOMAC-B indices [4] - Corticosteroid pretreatment was found to reduce treatment-induced NAb titers and related knee swelling [5] Future Developments - A Phase 2 study (ASCEND study) is currently underway for PCRX-201, building on the promising Phase 1 results [8] - The innovative design of PCRX-201 utilizes a high-capacity adenovirus vector platform to enhance treatment efficacy for chronic inflammation in knee osteoarthritis [2][9]
Pacira BioSciences to Present 3-Year Safety and Efficacy Data of PCRX-201 Following Single Intra-Articular Injection for Moderate-to-Severe Knee Osteoarthritis
Globenewswire· 2025-05-06 12:00
Core Insights - Pacira BioSciences, Inc. is presenting new data on its gene therapy candidate PCRX-201 at the 2025 EULAR Annual Congress, highlighting its commitment to innovative, non-opioid pain therapies [1] Group 1: Clinical Data and Study Results - The Phase 1 study of PCRX-201 demonstrated that a single intra-articular injection was safe and provided sustained clinical benefits for patients with moderate-to-severe knee osteoarthritis over three years [2] - In a previous Phase 1 study, PCRX-201 showed sustained improvements in knee pain, stiffness, and function for two years post-administration, with a well-tolerated safety profile [3] - PCRX-201 has received RMAT designation from the FDA and ATMP designation from the EMA, marking it as the first gene therapy to achieve these clinical results in knee osteoarthritis [3] Group 2: Ongoing Research and Development - Following promising Phase 1 results, dosing is currently underway in a Phase 2 study (ASCEND study) for the treatment of knee osteoarthritis [4] - The company is advancing the development of PCRX-201 as a novel, locally administered gene therapy aimed at treating prevalent diseases like osteoarthritis [5] Group 3: Company Overview - Pacira BioSciences focuses on delivering innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera® [5] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, while ZILRETTA is an extended-release injection for osteoarthritis knee pain [5]
Pacira BioSciences Announces Two-Year Efficacy Data Following a Single Local Administration of PCRX-201 in Patients with Mild to Severe Osteoarthritis of the Knee
Globenewswire· 2025-04-28 12:00
Core Insights - Pacira BioSciences, Inc. announced new data on its gene therapy candidate PCRX-201, showing sustained improvements in knee pain, stiffness, and function for up to two years after a single local administration in patients with varying severity of osteoarthritis [2][3][9] Study Findings - The study presented at the 2025 OARSI World Congress demonstrated that PCRX-201 provided clinically meaningful improvements across all structural severity subgroups, including advanced disease [1][2] - The open-label, phase 1 trial involved 72 patients aged 30 to 80, stratified by the severity of knee osteoarthritis, graded on the Kellgren-Lawrence scale [4] - Improvements in pain, stiffness, and function were assessed using the WOMAC and KOOS scores, showing significant reductions across all cohorts and severity levels [6][7] Treatment Efficacy - Patients receiving corticosteroid pretreatment experienced greater benefits, with pain reductions of 48%-65% and stiffness reductions of 53%-72%, compared to 41%-58% and 33%-53% in the non-pretreated cohort [7] - The greatest improvement was observed in patients with K/L grade 2 osteoarthritis [7] Safety Profile - No serious treatment-emergent adverse events were reported, with treatment-related joint effusions being the most common adverse event, occurring in 36% of the corticosteroid-pretreated group and 61% of the non-pretreated group [8] Regulatory Designations - PCRX-201 received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA in March 2024, facilitating efficient drug development and potential accelerated approval [9][10] - The therapy also received Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency in May 2023 [10][13] Future Developments - Following promising Phase 1 results, a Phase 2 study (ASCEND study) is underway for PCRX-201, focusing on the treatment of knee osteoarthritis [11][13] - The company aims to advance its position as an innovative biopharmaceutical entity through this development [9]