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Phase 4 IMPROVE Publication Finds EXPAREL®- Based Multimodal Analgesia Reduces Opioid Use, Adverse Events and Hospital Stay Following Laparoscopic Surgery
-- Results Reinforce Findings from IMPROVE Trial Series Demonstrating the Opioid-Sparing and Economic Benefits of EXPAREL Compared to Standard Opioid-Based Regimen --
The study evaluated 82 patients who underwent laparoscopic colectomy, a minimally invasive surgery to remove all or part of the colon using several small incisions in the abdomen. Compared to patients in the standard opioid-based treatment arm—who received intravenous (IV) opioids via patient-controlled analgesia (PCA) devices—patients undergoing the same procedure and receiving an EXPAREL-based multimodal regimen experienced:
- A 64 mg reduction in mean opioid consumption (32 mg in the EXPAREL group compared with 96 mg in the IV opioid-based PCA group; P<0.0001)
- A 1-day reduction in median length of hospital stay (3.0 days in the EXPAREL group compared with 4.0 days in the IV opioid-based PCA group; P=0.0019)
- Significantly fewer opioid-related adverse events (ORAEs) (8 percent of patients in the EXPAREL group experienced ORAEs, compared with 41 percent of patients in the IV opioid-based PCA group; P=0.0019)
$1,784reduction in mean hospitalization costs ( $11,234in the EXPAREL group compared with $13,018in the IV opioid-based PCA group)
“With a growing emphasis on minimizing the drawbacks of opioids,
clinicians are increasingly looking for effective analgesic agents that
can anchor an opioid-sparing multimodal pain management regimen while
demonstrating measurable advantages over the current standard of care,”
This study was conducted at six sites across
“There are millions of laparoscopic inpatient procedures performed
The full IMPROVE laparoscopic colectomy study publication is available online here.
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
EXPAREL (bupivacaine liposome injectable suspension) is 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 in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. 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 and prospects, including statements about our plans and
expectations regarding EXPAREL, and other statements containing the
words “believes,” “anticipates,” “plans,” “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 indications of EXPAREL to include nerve block; our plans to
continue to manufacture and provide support services for our commercial
partners who have licensed DepoCyt(e); our commercialization and
marketing capabilities; and other factors discussed in the “Risk
Factors” of our most recent Annual Report on Form 10-K for the fiscal