Pacira Biosciences is a pharmaceutical company focused on developing and commercializing non-opioid pain management solutions. Headquartered in Tampa, Florida, its core work involves using proprietary technology to provide therapies for post-surgical and chronic pain. The company’s work is centered in the United States, where it develops, manufactures, and sells its products.
A Mission for Non-Opioid Pain Management
The mission of Pacira Biosciences is directly shaped by the public health challenge of the opioid crisis. The widespread use of opioid medications for pain created a need for alternative treatments without the addictive properties associated with opioids. Pacira’s objective is to meet this demand by providing therapies that offer prolonged pain relief from a single administration.
This focus on non-addictive alternatives addresses a gap in patient care for acute pain management. Following surgical procedures, patients require pain relief to facilitate recovery. The company provides clinicians with tools to manage this pain for an extended period, reducing the potential for patients to be prescribed opioids upon discharge. This approach aligns with a broader shift in medicine towards minimizing opioid exposure.
Core Products and Delivery Technology
Pacira’s commercial strategy centers on two main products, EXPAREL and ZILRETTA, which are based on its proprietary DepoFoam drug delivery technology. This technology encapsulates drugs in microscopic, lipid-based particles called liposomes. This structure allows for the slow release of a medication over an extended period, providing sustained therapeutic effects from a single dose.
EXPAREL is a bupivacaine liposome injectable suspension used for post-surgical pain management. It is administered as a single dose into the surgical site during a procedure, where it slowly releases the local anesthetic bupivacaine for several days. This extended duration of local pain control is designed to reduce the need for other pain medications, including opioids, during the initial recovery period.
ZILRETTA is a triamcinolone acetonide extended-release injectable suspension. This product is indicated for managing osteoarthritis pain in the knee. An injection of ZILRETTA into the knee joint releases the corticosteroid triamcinolone acetonide over several weeks, which helps to reduce inflammation and pain associated with the condition. The extended-release mechanism aims to provide longer-lasting relief than standard immediate-release corticosteroid injections.
Navigating Legal and Regulatory Challenges
The company has encountered and managed legal and regulatory hurdles, particularly concerning its marketing practices. A notable event involved an investigation by the U.S. Department of Justice (DOJ) related to the off-label promotion of EXPAREL. The inquiry focused on allegations that the company was promoting the drug for uses not approved by the U.S. Food and Drug Administration (FDA).
The investigation concluded with a settlement, which included financial penalties and an agreement to adhere to specific compliance measures. In addition to the DOJ settlement, Pacira has engaged in ongoing dialogue with the FDA regarding product labeling and approved indications for its therapies.
Future Pipeline and Research Initiatives
Pacira Biosciences continues to invest in research and development to broaden the applications of its existing products and explore new therapeutic candidates. This involves conducting new clinical trials to demonstrate safety and efficacy in different types of surgeries or medical conditions, which could lead to wider patient access.
The company is also leveraging its DepoFoam technology to develop other potential treatments. One area of development includes a gene therapy platform, designated PCRX-201, intended for local administration to treat diseases like osteoarthritis.