Pacira Announces FDA Approval of Enhanced EXPAREL Manufacturing Process
Pacira BioSciences, Inc. recently announced the US FDA has approved the company’s enhanced manufacturing process for EXPAREL (bupivacaine liposome injectable suspension) which is housed at a custom facility in Swindon, England, under a partnership with Thermo Fisher Scientific Pharma Services. The company expects to start selling commercial product manufactured in this 200-liter suite later this year.
“This FDA approval underscores the quality assurance of our enhanced manufacturing process, which is essential as we scale the production of EXPAREL,” said Dave Stack, Chairman and Chief Executive Officer of Pacira BioSciences. “Launching this new manufacturing site marks an important milestone for Pacira that will allow us to double our capacity to meet the growing demand for EXPAREL, while simultaneously improving our gross margins and extending our market exclusivity into 2041.”
In June 2021, the United States Patent and Trademark Office (USPTO) issued US Patent No. 11,033,495 related to EXPAREL. The patent, Manufacturing of Bupivacaine Multivesicular Liposomes, claims composition of EXPAREL prepared by the improved manufacturing process and has an expiration date of January 22, 2041. Pacira submitted this patent for listing in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) in July 2021.
Pacira BioSciences, Inc. is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients’ journeys along the neural pain pathway. The company’s long-acting local analgesic, EXPAREL (bupivacaine liposome injectable suspension) was commercially launched in the US in April 2012. EXPAREL utilizes DepoFoam, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. For more information, visit www.pacira.com.
EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. For more information, visit www.EXPAREL.com.
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