Company Description
Pacira BioSciences, Inc. (NASDAQ: PCRX) is a pharmaceutical company focused on non-opioid pain management and regenerative health solutions. According to company disclosures, Pacira "delivers innovative, non-opioid pain therapies to transform the lives of patients" and has a portfolio that spans commercialized products for postsurgical and musculoskeletal pain as well as a clinical-stage gene therapy platform targeting osteoarthritis of the knee.
Pacira is classified in Pharmaceutical Preparation Manufacturing within the Manufacturing sector and its common stock is listed on the Nasdaq Global Select Market under the symbol PCRX, as noted in its SEC filings. The company reports that it has three commercial-stage non-opioid treatments—EXPAREL, ZILRETTA and iovera°—and is advancing PCRX-201 (enekinragene inzadenovec), a locally administered gene therapy in Phase 2 clinical development for osteoarthritis of the knee.
Core business focus: non-opioid pain therapies
Pacira describes itself as an "industry leader" in its commitment to deliver non-opioid pain therapies. Its business centers on developing, manufacturing and commercializing products that manage pain without relying on opioid medications. This includes postsurgical local and regional analgesia, osteoarthritis knee pain management, and device-based cryoneurolysis for peripheral nerve pain.
The company’s public communications emphasize a strategy sometimes referred to as its "5x30" growth strategy and highlight efforts to expand access to its products through commercial partnerships, clinical development and geographic expansion. For example, Pacira announced an agreement granting LG Chem exclusive rights to commercialize EXPAREL in select Asia-Pacific markets, with Pacira manufacturing EXPAREL and LG Chem responsible for regulatory approvals and commercialization in those territories.
Key commercial products
EXPAREL® (bupivacaine liposome injectable suspension) is Pacira’s long-acting local anesthetic for postsurgical pain management. Company materials state that EXPAREL is:
- Indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older.
- Indicated for postsurgical regional analgesia via an interscalene brachial plexus block in adults, a sciatic nerve block in the popliteal fossa in adults, and an adductor canal block in adults.
- Formulated by combining bupivacaine with multivesicular liposomes (pMVL), a drug delivery technology that releases medication over a desired time period.
- Described as the first and only multivesicular liposome local anesthetic that can be used in peri- or postsurgical settings.
Pacira reports that a single dose of EXPAREL delivers bupivacaine over time and has been associated with reductions in cumulative pain scores and decreased opioid consumption in clinical studies, while also noting that the clinical benefit of opioid reduction was not demonstrated.
ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) is an extended-release intra-articular injection indicated for the management of osteoarthritis (OA) knee pain. Company information notes that:
- ZILRETTA was approved by the U.S. Food and Drug Administration on October 6, 2017 as the first and only extended-release intra-articular therapy for OA-related knee pain.
- It uses proprietary microsphere technology that combines triamcinolone acetonide with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief.
- The pivotal Phase 3 trial supporting approval showed significant reductions in OA knee pain for 12 weeks, with some patients experiencing pain relief through Week 16.
iovera®° is a handheld device for drug-free pain control using targeted cold. Pacira describes iovera° as:
- A system that uses the body’s natural response to cold to treat peripheral nerves and immediately reduce pain without drugs.
- Applying focused cold (cryoneurolysis) to a targeted peripheral nerve to temporarily interrupt its ability to transmit pain signals.
- Providing pain relief that is typically immediate and can last up to 90 days, with function returning as the nerve regenerates.
- Not indicated for treatment of central nervous system tissue.
The company has highlighted clinical data for iovera° in chronic low back pain, reporting favorable safety and improvements in pain and functional outcomes compared with radiofrequency ablation in a 12‑month pilot study.
Pipeline and gene therapy platform
Beyond its commercial products, Pacira is advancing PCRX-201 (enekinragene inzadenovec), which it describes as a novel, locally administered gene therapy for osteoarthritis of the knee. Company communications state that:
- PCRX-201 is based on a high-capacity adenovirus (HCAd) vector platform acquired through Pacira’s acquisition of GQ Bio Therapeutics GmbH.
- The therapy targets chronic inflammatory processes that contribute to osteoarthritis of the knee.
- In a large Phase 1 study, 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 Product (ATMP) designation from the European Medicines Agency.
- Dosing is underway in a Phase 2 study (ASCEND) for knee osteoarthritis.
Pacira notes that this gene therapy platform is part of its strategy to address large, prevalent conditions such as osteoarthritis and that PCRX-201 is the first gene therapy to achieve the specific regulatory designations and clinical results it has reported in osteoarthritis of the knee.
Manufacturing and operational footprint
Pacira has described multi-year investments in manufacturing capacity for EXPAREL. An 8‑K filing details that the company operates large-scale manufacturing suites in San Diego, California, and Swindon, United Kingdom, capable of producing bulk EXPAREL volumes approximately four-fold greater than its earlier 45‑liter batch process. As part of improving manufacturing efficiencies, Pacira decided to decommission its 45‑liter suite in San Diego and implemented a reduction in force at its Science Center Campus there.
The company states that these larger manufacturing suites are expected to provide ample capacity to meet growing demand for EXPAREL and to support a more favorable cost structure and manufacturing yields compared with the earlier process. Pacira has also entered into a senior secured revolving credit facility to support working capital and refinance prior indebtedness, as disclosed in its credit agreement 8‑K.
Research collaborations and data initiatives
Pacira participates in collaborative efforts aimed at advancing osteoarthritis research. It announced that it joined the PROBE (Patient Relevant Osteoarthritis endpoints using Big data Evaluation) Consortium, a public‑private partnership funded by the European Innovative Health Initiative. According to Pacira, PROBE brings together partners from academia, industry, patient organizations, regulators and health professionals to:
- Create a regulation-compliant database network to analyze unidentified patient data from multiple OA cohorts and registries.
- Use AI models to predict disease progression and support personalized medicine.
- Develop novel multi-modal trial endpoints for better treatment evaluation.
- Provide tools for shared decision-making between patients and healthcare providers.
Pacira has stated that it will contribute data from its ASCEND study of PCRX-201 and other osteoarthritis-related research to this initiative.
Capital markets and shareholder matters
Pacira is an established public company with ongoing engagement in the capital markets. It regularly files current reports on Form 8‑K regarding quarterly financial results, financing arrangements and operational changes. The company has disclosed share repurchase activity under a board-authorized repurchase program and has reported inducement equity grants to new employees under its inducement plan, in accordance with Nasdaq Listing Rule 5635(c)(4).
Pacira has also been the subject of shareholder activism. Public communications from DOMA Perpetual Capital Management LLC, a significant stockholder, describe DOMA’s intention to nominate director candidates at Pacira’s annual meeting and urge the board to explore a potential sale of the business. These materials reflect the views of that shareholder and are not company statements, but they illustrate that Pacira’s governance and strategic direction are topics of active investor discussion.
Regulatory and safety information
As a pharmaceutical and medical device company, Pacira’s products carry detailed prescribing and safety information. Company communications emphasize:
- Specific indications and limitations of use for EXPAREL, including age restrictions and routes of administration that have not been established as safe and effective.
- Contraindications and warnings for ZILRETTA, such as hypersensitivity to triamcinolone acetonide or corticosteroids, and the requirement that it be used only via intra-articular injection.
- Usage limitations and safety considerations for iovera°, including contraindications in patients with hypersensitivity to cold or infected wounds near the treatment site, and potential local side effects.
Investors and healthcare professionals typically refer to full prescribing information, device labeling and regulatory documents for complete details on indications, dosing, safety and risk factors.
Position within the pharmaceutical manufacturing sector
Within the broader pharmaceutical preparation manufacturing industry, Pacira is distinct in its focus on non-opioid pain therapies that span injectable pharmaceuticals, extended-release formulations and device-based treatments, alongside a gene therapy pipeline. Its operations, as described in public filings and press releases, combine commercial manufacturing, clinical development, intellectual property protection and collaborations with external partners and distributors.