PARSIPPANY, NJ, September 30, 2021 (GLOBE NEWSWIRE) – Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, announced Today, the successful completion of process validation and commercial production of EXPARELÂ® (bupivacaine liposome injectable suspension) are now underway in its custom 200 liter manufacturing room in Swindon, England. The suite was developed in a partnership with Thermo Fisher Scientific Pharma Services. Pacira plans to start selling commercial products made in the 200-liter suite before the end of 2021.
âCompleting our 200 liter validation process is a key milestone that doubles our manufacturing capacity to meet growing demand from EXPAREL and puts us on track to achieve EXPAREL gross margins above 85% of here 2024, âsaid Dave Stack, President and CEO of Pacira BioSciences. âIt is important to note that this improved process has allowed us to add another layer of commercial exclusivity for EXPAREL through the issuance of a new Orange Book patent which extends our ownership position until January 2041. “
In July 2021, the United States Food and Drug Administration (FDA) approved the company’s improved manufacturing process and subsequently listed the United States patent which claims the composition of EXPAREL prepared by this process in its ” Drug Products Approved with Therapeutic Equivalence Reviews â(The Orange Book). Process validation is required by the FDA before a product from a new manufacturing process is marketed for use by consumers to demonstrate that the process will consistently produce a pharmaceutical product that meets predefined specifications.
About Pacira BioSciences Pacira BioSciences, Inc. (Nasdaq: PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve the patient journey along the path to neural pain. The company’s long-acting local pain reliever, EXPARELÂ® (bupivacaine liposome injection suspension) was launched commercially in the United States in April 2012. EXPAREL uses DepoFoamÂ®, a unique product delivery technology and proprietary drug that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera Â° System, a portable cryo-analgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the company’s mission to reduce excessive opioid dependence, visit www.pacira.com.
EXPAREL (bupivacaine liposome suspension for injection) is indicated in patients aged 6 years and older for single-dose infiltration to produce post-surgical local analgesia, and in adults as an interscalene nerve block of the brachial plexus to produce regional analgesia. post-surgical. Safety and effectiveness have not been established in other nerve blocks. Since its launch, EXPAREL has been used in more than nine million patients. The product combines bupivacaine with DepoFoamÂ®, a proven product delivery technology that delivers drugs over a desired period of time. EXPAREL represents the first and only local anesthetic with multivesicular liposomes that can be used in the peri- or post-surgical setting. Using the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, offering significant reductions in cumulative pain scores with up to 78% decrease in opioid use; the clinical benefit of reducing opioids has not been demonstrated. Additional information is available at www.EXPAREL.com.
Important safety information for patients
EXPAREL should not be used in the setting of paracervical obstetric block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low red blood cell count, muscle twitching, blurred vision, itching and rapid heartbeat. EXPAREL may cause temporary loss of sensation and / or loss of muscle movement. The amount and duration of the loss of sensation and / or muscle movement depends on where and how much EXPAREL is injected and may last for up to 5 days. EXPAREL is not recommended in patients less than 6 years old for injection into a wound, in patients less than 18 years old for injection near a nerve and / or in pregnant women. Tell your healthcare provider if you or your child has liver disease, as this may affect the way the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints or veins. The active substance in EXPAREL may affect the nervous system and the cardiovascular system; may cause an allergic reaction; can cause damage if injected into the joints; and can cause a rare blood disorder.
Company Contact: Pacira BioSciences, Inc. Susan Mesco, (973) 451-4030 [email protected]
Media Contact: Coyne Public Relations Kristin Capone (973) 588-2108 [email protected]
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