This section highlights FDA-related milestones and regulatory updates for drugs developed by Pacira BioSciences (PCRX).
Over the past two years, Pacira BioSciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EXPAREL, iovera°, and PCRX-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
EXPAREL (Bupivacaine Liposome Injectable Suspension) FDA Regulatory Timeline and Events
EXPAREL (Bupivacaine Liposome Injectable Suspension) is a drug developed by Pacira BioSciences for the following indication: Postsurgical Analgesia in Children.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EXPAREL (Bupivacaine Liposome Injectable Suspension)
- Announced Date:
- April 27, 2026
- Indication:
- Postsurgical Analgesia in Children
Announcement
Pacira BioSciences, Inc. announced findings from a real-world study evaluating the clinical and economic impact of EXPAREL® (bupivacaine liposome injectable suspension) on opioid use, healthcare resource utilization, and total medical costs following outpatient total hip arthroplasty among Medicare patients.
AI Summary
Pacira BioSciences reported results from a retrospective real-world study comparing EXPAREL (liposomal bupivacaine) with standard non‑liposome bupivacaine in Medicare patients after outpatient total hip arthroplasty. Researchers analyzed Centers for Medicare & Medicaid Services claims data and followed patients for up to 12 months after surgery.
The study found that patients who received EXPAREL had lower postoperative opioid use, reduced healthcare resource use (fewer readmissions, emergency department visits, and outpatient encounters), and lower total medical costs compared with those who received non‑liposome bupivacaine. These clinical and economic differences were observed across the 12‑month follow‑up period, suggesting potential sustained benefits when EXPAREL is used in multimodal pain management for outpatient hip replacement.
Because the analysis was retrospective and based on claims data, results should be interpreted with caution, but they support EXPAREL’s potential to reduce opioid exposure and healthcare burden in this population.
Read Announcement- Drug:
- EXPAREL (Bupivacaine Liposome Injectable Suspension)
- Announced Date:
- March 30, 2026
- Indication:
- Postsurgical Analgesia in Children
Announcement
Pacira BioSciences, Inc. announced findings from two real-world studies evaluating the economic benefits of EXPAREL® (bupivacaine liposome injectable suspension) in orthopaedic procedures, including total knee arthroplasty (TKA) and spinal fusion. I
AI Summary
Pacira BioSciences announced results from two real-world, propensity score–matched cohort studies that evaluated the economic impact of EXPAREL (bupivacaine liposome injectable suspension) in orthopedic surgeries, including total knee arthroplasty (TKA) and spinal fusion. The analyses examined outcomes on the day of surgery and across 30 days of follow-up in both commercial and Medicare Advantage patient groups. Across both studies, EXPAREL was associated with lower total costs of care and reductions in selected healthcare resource use.
In the spinal fusion study, most of the cost and resource use reductions were driven by a shorter hospital length of stay. Jonathan Slonin, Pacira’s chief medical officer, said the findings support EXPAREL’s role in multimodal, non-opioid pain management and suggest it can improve patient outcomes while easing economic barriers to access for hospitals, payers, and patients.
Read Announcement- Drug:
- EXPAREL (Bupivacaine Liposome Injectable Suspension)
- Announced Date:
- October 23, 2025
- Indication:
- Postsurgical Analgesia in Children
Announcement
Pacira BioSciences, Inc. announced real-world evidence evaluating the clinical effectiveness and economic benefits of EXPAREL® (bupivacaine liposome injectable suspension) will be presented at the AMCP Nexus 2025 Annual Meeting taking place October 27–30 in National Harbor, Maryland.
AI Summary
Pacira BioSciences will present new real-world data on EXPAREL® (bupivacaine liposome injectable suspension) at the AMCP Nexus 2025 Annual Meeting in National Harbor, Maryland, October 27–30. The findings come from the Innovations in Genicular Outcomes Registry (IGOR), a multicenter, prospective study tracking postsurgical pain management.
Jennifer Lin, Senior Director of Health Economics and Outcomes Research, will share how intraoperative EXPAREL reduced pain scores, opioid use, and hospital stays after total knee arthroplasty. Gabriel Wong, also Senior Director of Health Economics and Outcomes Research, will present two posters: one on clinical and economic outcomes for Medicare patients undergoing outpatient shoulder arthroplasty, and another on healthcare resource utilization and costs in ambulatory surgical centers for knee replacement.
These presentations highlight EXPAREL’s potential to improve patient recovery, lower opioid reliance, and reduce downstream healthcare costs through multimodal pain management strategies.
Read Announcement- Drug:
- EXPAREL (Bupivacaine Liposome Injectable Suspension)
- Announced Date:
- October 21, 2025
- Indication:
- Postsurgical Analgesia in Children
Announcement
Pacira BioSciences, Inc. today reported it has received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of a small private Chinese company.
AI Summary
Pacira BioSciences, Inc., a leader in non-opioid pain care, today said it received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of Zhejiang Haichang Biotechnology. WhiteOak has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking to market a generic version of EXPAREL. Neither WhiteOak nor its parent has any commercial products.
In its PIV Notice, WhiteOak alleges that the claims of 19 EXPAREL patents listed in the FDA’s Orange Book are invalid, unenforceable or would not be infringed by its product. Those patents fall into two families, one expiring on January 22, 2041, and the other on July 2, 2044.
Under the Hatch-Waxman Act, Pacira has 45 days to sue if it believes WhiteOak’s ANDA infringes its patents. Filing suit would trigger an automatic 30-month stay on FDA approval of WhiteOak’s ANDA. Pacira said it will vigorously protect its intellectual property rights.
Read Announcement
Iovera° FDA Regulatory Events
Iovera° is a drug developed by Pacira BioSciences for the following indication: drug-free treatment that relieves pain via cryoneurolysis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- iovera°
- Announced Date:
- December 2, 2025
- Indication:
- drug-free treatment that relieves pain via cryoneurolysis
Announcement
Pacira BioSciences, Inc. announced results from a randomized 30-patient pilot study evaluating iovera° cryoneurolysis versus radiofrequency ablation (RFA) for chronic low back pain (CLBP).
AI Summary
Pacira BioSciences reported results from a randomized, single-center 30‑patient pilot study comparing iovera° cryoneurolysis to radiofrequency ablation (RFA) for facet-mediated chronic low back pain (CLBP). The unblinded study followed patients for 12 months and found clinically meaningful benefits with iovera° on pain and function.
At day 180, mean pain scores were lower with iovera° (3.1) than RFA (5.4; p=0.01), and this difference persisted at day 360 (3.0 vs. 6.1; p=0.01). Functional disability (Oswestry Disability Index) was significantly better with iovera° at day 360 (10.1 vs. 20.6; p=0.002). Fewer iovera° patients needed additional spine injections by 180 days (45.5% vs. 75%). No treatment‑related adverse events were reported in either group over 12 months.
iovera° is a drug‑free, tissue‑sparing cryoneurolysis treatment that provides immediate relief lasting up to about 90 days. Study limits included lack of blinding and device tip length that restricted use to patients with lower body mass index.Read Announcement
- Drug:
- iovera°
- Announced Date:
- January 7, 2025
- Indication:
- drug-free treatment that relieves pain via cryoneurolysis
Announcement
Pacira BioSciences, Inc. announced that that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a new Smart Tip designed to access the medial branch nerves to manage chronic low back pain.
AI Summary
Pacira BioSciences has received clearance from the U.S. Food & Drug Administration to market a new Smart Tip designed to reach the medial branch nerves and manage chronic low back pain. This innovative 25-gauge, 180-mm Smart Tip is part of the iovera° system, a drug‐free treatment that uses cryoneurolysis—precise, controlled cold therapy—to temporarily block pain signals. The new Smart Tip is specially engineered to access deeper nerves, offering patients immediate pain relief that can last for months as the nerve gradually regenerates. With this advancement, Pacira aims to provide an effective alternative to conventional treatments, reducing reliance on opioids and mitigating common side effects. This FDA clearance marks a significant step forward in offering a safe and novel approach to alleviate chronic facet-mediated low back pain for millions of patients.
Read Announcement
PCRX-201 FDA Regulatory Timeline and Events
PCRX-201 is a drug developed by Pacira BioSciences for the following indication: For the Treatment of Osteoarthritis of the Knee.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PCRX-201
- Announced Date:
- November 5, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc. announced that it has concluded patient enrollment in Part A of its Phase 2 ASCEND study evaluating PCRX-201 (enekinragene inzadenovec) for the treatment of osteoarthritis (OA) of the knee.
AI Summary
Pacira BioSciences announced completion of patient enrollment in Part A of its Phase 2 ASCEND study of PCRX-201 gene therapy for knee osteoarthritis. This milestone begins a two-part trial to test safety and effectiveness, with topline results expected by late 2026.
PCRX-201 is injected into the knee to increase interleukin-1 receptor antagonist (IL-1Ra) and block inflammation. Its design includes an inducible promoter that “turns on” IL-1Ra when needed and “turns off” when inflammation subsides.
About 135 patients aged 45–80 with moderate to severe knee OA will join. In Part A, 45 patients were randomized to two PCRX-201 doses or saline, all with steroid pretreatment. Results will guide Part B of 90 patients using commercial-scale manufacturing.
The main goal is to assess safety through Week 52; secondary goals include changes in pain and function. Participants will be followed for five years.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- October 28, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc. announced updated three-year results and a new subset analyses demonstrating sustained efficacy and safety across all patient subgroups, including varying disease severities, from its open-label Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a novel gene therapy candidate for osteoarthritis of the knee.
AI Summary
Pacira BioSciences reported three-year results from its open-label Phase 1 trial of PCRX-201 (enekinragene inzadenovec), a gene therapy for knee osteoarthritis. After a single ultrasound-guided injection at low, mid or high doses, patients saw lasting improvements in pain, stiffness and function through 156 weeks, measured by WOMAC and KOOS scores. No serious treatment-related adverse events occurred, and joint swelling was the most common side effect.
New subgroup analyses showed consistent benefits across disease severities (Kellgren-Lawrence grades 2–4) and in patients with or without prior corticosteroid pretreatment. Pre-existing anti-adenovirus antibodies did not reduce efficacy or safety, suggesting possible re-dosing potential. These findings support the ongoing Phase 2 ASCEND study design using a lower PCRX-201 dose with corticosteroid pretreatment.
The data will be presented at the American College of Rheumatology Convergence 2025, highlighting PCRX-201’s promise for long-term relief from knee osteoarthritis after a single injection.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- October 20, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc. announced that new data from its Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a novel gene therapy candidate for osteoarthritis of the knee, will be presented at the American College of Rheumatology (ACR) Convergence 2025 meeting, taking place from October 24-29 in Chicago, Il.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- June 11, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc 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.
AI Summary
Pacira BioSciences, Inc. has announced new long-term follow-up data from its Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a promising gene therapy candidate for osteoarthritis of the knee. In this study, a single intra-articular injection of PCRX-201 was well tolerated and produced sustained improvements in pain, stiffness, and function for up to three years. The trial involved patients with moderate-to-severe osteoarthritis of the knee and showed meaningful clinical benefits, with reductions in symptoms that extend far beyond the typical three to six months offered by current treatments. The results, which include significant improvements on various knee assessment scores, highlight PCRX-201’s potential as a disease-modifying therapy that targets chronic inflammation at a cellular level. These findings will be shared during a poster session at the upcoming 2025 EULAR Congress in Barcelona, Spain.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- May 15, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc. 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.
AI Summary
Pacira BioSciences, Inc. announced new preliminary data showing that clinical immunogenicity does not affect the long-term benefits of its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), for knee osteoarthritis. The findings indicate that both pre-existing and treatment-induced anti-Ad5 neutralizing antibodies do not compromise the safety or effectiveness of the treatment. This gene therapy, delivered via a local knee injection, has been shown to provide sustained improvements in pain, stiffness, and function across patients with mild, moderate, and severe osteoarthritis.
The results were presented during a podium session at the ASGCT Annual Meeting. By overcoming a key challenge common to many gene therapies—the body’s natural immune response—the data supports PCRX-201 as a promising, durable treatment option for patients seeking long-lasting relief from osteoarthritis symptoms.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- May 6, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc announced new data from its ongoing Phase 1 study of its gene therapy candidate PCRX-201 (enekinragene inzadenovec).
AI Summary
Pacira BioSciences has announced encouraging new data from its ongoing Phase 1 study of the gene therapy candidate PCRX-201 (enekinragene inzadenovec). The study, presented at the 2025 European Alliance of Associations for Rheumatology Annual Congress in Barcelona, Spain, focused on using a single intra-articular injection to treat moderate-to-severe knee osteoarthritis. Led by Professor Philip G. Conaghan of the University of Leeds, UK, the findings indicate that the treatment was safe and provided sustained clinical benefits through three years. PCRX-201 uses a novel high-capacity adenovirus vector platform to target the chronic inflammatory processes found in osteoarthritis. These results show promise for long-term relief and improved joint function, supporting further clinical development of this innovative gene therapy candidate.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- May 2, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc. announced an upcoming podium presentation of findings from its Phase 1 study of PCRX-201 (enekinragene inzadenovec), a locally administered gene therapy candidate for osteoarthritis of the knee.
AI Summary
Pacira BioSciences announced an upcoming podium presentation at the 28th Annual Meeting of the American Society of Gene and Cell Therapy in New Orleans. The presentation will focus on findings from the Phase 1 study of PCRX-201 (enekinragene inzadenovec), a gene therapy candidate developed to treat osteoarthritis of the knee. Researchers will discuss how both preexisting and treatment-induced neutralizing antibodies affect the treatment’s efficacy, safety, and potential for redosing. The findings will be presented by Dr. MiJeong Kim, Senior Director of Translational Sciences at Pacira, on May 15 from 2:15 to 2:30 PM CT. This research utilizes a proprietary high-capacity adenovirus vector platform and may offer new insights into effective dosing strategies for managing chronic inflammatory processes involved in knee osteoarthritis.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- April 28, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc. announced new data demonstrating its locally administered gene therapy candidate, PCRX-201 (enekinragene inzadenovec), provided sustained improvements in knee pain, stiffness, and function for up to two years following a single local administration in patients with mild, moderate, as well as severe osteoarthritis of the knee.
AI Summary
Pacira BioSciences recently presented promising data on its gene therapy candidate, PCRX-201 (enekinragene inzadenovec). The study showed that a single local injection provided long-lasting improvements in knee pain, stiffness, and function for patients with osteoarthritis, regardless of whether the severity was mild, moderate, or severe. The therapy works by boosting the production of a natural protein that helps block inflammation, addressing not just the symptoms but the underlying causes of the disease.
These results suggest that PCRX-201 could transform treatment by offering relief that lasts for up to two years after just one injection. This innovative approach may provide patients with a new option for managing their knee osteoarthritis more effectively, potentially reducing the need for frequent treatments and improving overall quality of life.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- April 3, 2025
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc. announced the first patient has been dosed in the Phase 2 ASCEND study of PCRX-201 (enekinragene inzadenovec) for the treatment of osteoarthritis, or OA, of the knee.
AI Summary
Pacira BioSciences, Inc. has reached an important milestone in its effort to improve treatments for knee osteoarthritis. The company announced that the first patient has been dosed in the Phase 2 ASCEND study of PCRX-201 (enekinragene inzadenovec). This novel gene therapy is designed to be injected directly into the knee joint to boost the production of an anti-inflammatory protein called IL-1Ra. By increasing IL-1Ra levels, PCRX-201 aims to block the interleukin-1 pathway, which is known to drive inflammation and pain in osteoarthritis. The study will involve about 135 patients and will test different doses of the treatment, along with a corticosteroid pretreatment to improve tolerability. Topline results from this study are expected by late 2026, marking a promising step toward a more effective and long-lasting therapy for osteoarthritis of the knee.
Read Announcement- Drug:
- PCRX-201
- Announced Date:
- September 26, 2024
- Target Action Date:
- November 17, 2024
- Indication:
- For the Treatment of Osteoarthritis of the Knee
Announcement
Pacira BioSciences, Inc. announced the upcoming presentation of new data in support of its gene therapy candidate, PCRX-201 (enekinragene inzadenovec). The data will be presented at the American College of Rheumatology's annual ACR Convergence meeting, being held in Washington, D.C. November 14–19.
AI Summary
Pacira BioSciences, Inc. announced new data supporting its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), will be presented at the American College of Rheumatology's annual ACR Convergence meeting. The event takes place in Washington, D.C. from November 14 to 19, and the presentation is scheduled for Sunday, November 17 between 10:30 am and 12:30 pm EST. PCRX-201 is a locally administered gene therapy aimed at treating moderate-to-severe osteoarthritis of the knee. It works by producing interleukin-1 receptor antagonist (IL-1Ra), an anti-inflammatory protein that helps reduce IL-1 signaling, a key factor in knee osteoarthritis. This innovative approach targets the affected joint directly, mimicking the body’s natural response to inflammation and potentially reducing pain, disability, and further joint damage.
Read Announcement
