Pacira Announces Publication of Phase 3 Study of EXPAREL Infiltration in Pediatric Patients Undergoing Spinal or Cardiac Surgeries

Study demonstrating safety and tolerability of EXPAREL, published in Journal of Clinical Anesthesia

PARSIPPANY, NJ, Sept. 21, 2021 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX) announced today that the full results of its Phase 3 PLAY trial of EXPAREL® (bupivacaine liposome injectable suspension), administered by infiltration in pediatric patients undergoing spinal or cardiac surgery, have been published in Journal of Clinical Anesthesia . The study, designed to determine the safety and pharmacokinetics (PK) of EXPAREL in a pediatric population, found that the PK profile was similar across age groups and generally consistent with the profile in adult patients. No safety concerns were identified at a dose of 4 mg/kg.

Key findings include:

The safety of EXPAREL was comparable to that of bupivacaine and consistent across treatment groups.

There were no treatment-related cardiac or nervous system adverse events (AEs) in the EXPAREL arm.

EXPAREL was well tolerated in all age groups, with no discontinuations due to adverse reactions.

“Traditionally, clinicians seeking pain management in pediatric patients have been forced to choose between opioids or traditional local anesthetics that require the use of cumbersome catheters or pumps to provide the duration of pain management required in historically painful surgical procedures,” said Christopher Tirotta, MD, chief of anesthesiology at Nicklaus Children’s Hospital and lead author of the PLAY study. “The results of this study demonstrate the excellent safety profile of EXPAREL, which provides long-term pain management and versatility of administration without many of the unwanted side effects often associated with opioids.”

The PLAY study formed the basis of the US Food and Drug Administration (FDA) approval of the EXPAREL label extension with single-dose infiltration to produce postoperative local analgesia in patients 6 years of age and older on March 22. 2021.

This study was a multicenter, open-label, randomized study that enrolled 98 patients in two patient groups: patients 12 to less than 17 years of age and patients 6 to less than 12 years of age. The results showed that plasma bupivacaine levels after local infiltration with EXPAREL remained below the toxic threshold in adults across all age groups and procedures. In addition, adverse reactions were mild to moderate, supporting the safety of EXPAREL in pediatric patients undergoing spinal or cardiac surgery.

Story continues

Dosing for both age groups was weight-based, with dose selection focusing on using the maximum dose of each drug that would be predictably safe. In all age groups and surgical procedures, surgeons administered EXPAREL or bupivacaine HCl by topical infiltration prior to wound closure, with EXPAREL and bupivacaine HCl administered in small increments into the deep and superficial layers along the entire length of the incision site to ensure a uniform distribution of to guarantee the medicine.

“Children undergoing surgery often experience moderate to severe pain after their procedure, and unmanaged postoperative pain often leads to delayed healing, extended length of stay, and even the development of chronic postoperative pain,” said Roy Winston, MD, chief medical officer at Pacira . “We are grateful for the opportunity to offer EXPAREL, the first and only FDA-approved long-acting topical analgesic for the pediatric population aged six and up, as a safe and effective pain management option for pediatric patients and their families.”

The results of this study build on a growing body of evidence supporting the use of EXPAREL in pediatric procedures. A recent retrospective cohort study found that in patients ≤ 18 years of age undergoing surgery to correct spinal misalignment, the administration of EXPAREL via wound infiltration was associated with lower pain scores, reduced opioid consumption, and a lower complication rate than standard pain treatment.1

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 patients’ journey along the neural pain pathway. The company’s long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL uses DepoFoam®, a unique and patented product delivery technology that encapsulates drugs without changing their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iora° System, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. Visit www.pacira.com to learn more about Pacira, including the company’s mission to reduce opioid over-reliance.

About EXPAREL®

EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single dose infiltration to produce postoperative local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postoperative regional analgesia. Safety and efficacy have not been established with other nerve blocks. Since its launch, EXPAREL has been used in more than nine million patients. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired period of time. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be used in the peri- or post-operative setting. Leveraging the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing a significant reduction in cumulative pain scores with up to 78 percent reduction in opioid consumption; the clinical benefit of the opioid reduction has not been demonstrated. Additional information is available at www.EXPAREL.com.

Important Patient Safety Information

EXPAREL should not be used in obstetric paracervical block anaesthesia. In adult studies where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In adult studies 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 fast heart rate. EXPAREL may cause a temporary loss of sensation and/or loss of muscle movement. How much and for how long the loss of sensation and/or muscle movement depends on where and how much EXPAREL was injected and can last up to 5 days. EXPAREL is not recommended for use in patients under 6 years of age for injection into the wound, in patients under 18 years of age 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 can affect the nervous and cardiovascular system; can 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 susan.mesco@pacira.com

Media contact:
Coyne Public Relations
Kristin Capone
(973) 588-2108
kcapone@coynepr.com

1 Chughtai, M., Sultan, AA, Hudson, B., Goodwin, R.C., Seif, J., Khlopas, A., … & Ballock, R.T. (2020). Liposomal bupivacaine is both safe and effective in managing postoperative pain after spinal surgery in children: a controlled cohort study. Clinical Spine Surgery, 33(10), E533-E538.

Comments are closed.