|New Data Demonstrate Reduced Opioid Requirements Following Use of EXPAREL in Hysterectomy and Mastectomy Procedures|
Data Presented at the 2015 Annual Meeting of the
The first study compared the efficacy of EXPAREL to bupivacaine HCl when infiltrated into the transversus abdominis plane (TAP) to provide postsurgical analgesia following robotic assisted hysterectomy in 60 women. Blinded assessments of pain intensity, opioid intake and incidence of adverse events were taken for up to 72 hours after the procedure. In comparison to the bupivacaine HCl treatment group, patients who received TAP infiltration with EXPAREL had:
“Opioid use in patients undergoing abdominal surgeries can be
particularly challenging, as their surgical intervention already
increases the risk for gastrointestinal complications such as
constipation and ileus, which we know opioids can exacerbate,” said
The IARS annual meeting also featured a case review assessing the impact
of EXPAREL on postsurgical opioid consumption in a mastectomy patient
with several risk factors, including morbid obesity, chronic obstructive
pulmonary disease (COPD) with a greater than 40 pack-year history of
smoking, and a history of opioid induced nausea and vomiting, all of
which increase the risk of serious opioid-related complications. In the
case study, the patient underwent radical mastectomy with axillary lymph
node dissection and had EXPAREL infiltrated into the wound prior to skin
closure. The case outcome, presented by
“Minimizing the opioid burden on patients in the postsurgical setting is
integral to breaking the cycle of opioid overuse, chronic use and abuse,
all of which fuel the national opioid epidemic,” said
More than 70 million patients per year receive opioids in a hospital or
clinic following surgery,1,2 and approximately one out of
every 15 surgery patients in
EXPAREL is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. 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 score with up to a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.
Please see the full Prescribing Information for more details available at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans, outlook and prospects, including statements about our expected
revenues, and other statements containing the words “believes,”
“anticipates,” “plans,” “estimates,” “expects,” and similar expressions,
constitute forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements as a
result of various important factors, including risks relating to: the
success of our sales and manufacturing efforts in support of the
commercialization of EXPAREL; the rate and degree of market acceptance
of EXPAREL; the size and growth of the potential markets for EXPAREL and
our ability to serve those markets; our plans to expand the use of
EXPAREL to additional indications, including nerve block, oral surgery
and chronic pain, as well as pediatrics; the related timing and success
1 Adamson, et al.
2 Kessler, E. Richard, et al. "Cost and Quality Implications
of Opioid‐Based Postsurgical Pain Control Using Administrative Claims
Data from a
3 Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, et al. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med, 2012; 172(5): 425-30.
4 Carroll I, Barelka P, Wang CK, Wang BM, Gillespie MJ, et al. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg, 2012; 115(3): 694-702.