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
iovera° and PCRX-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
iovera° - FDA Regulatory Timeline and 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:
- 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:
- 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
- Estimated Event Date Range:
- November 17, 2024 - November 17, 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
