Pacira Pharmaceuticals, Inc. Announces Publication of Pooled Results from IMPROVE Studies Evaluating Health Economic Benefits of EXPAREL®
-- Multi-study Analysis Published in
The IMPROVE studies were conducted at 13 centers and evaluated a total of 191 patients, who underwent three frequently performed gastrointestinal surgeries: open colectomy, laparoscopic colectomy and ileostomy reversal. Of the 191 patients included in the analysis, 105 received an opioid-based analgesic regimen via intravenous (IV) patient-controlled analgesia (PCA), while 86 patients received an EXPAREL-based multimodal pain management regimen. According to the analysis, the EXPAREL group was associated with:
- A 60 percent reduction in total narcotic consumption (38 mg versus 96 mg in the IV opioid PCA group; P < 0.0001)
- A 67 percent reduction in incidence of ORAEs (9 percent versus 27 percent in the IV opioid PCA group; P = 0.0027)
- A 1.4 day reduction in median length of hospital stay (2.9 versus 4.3 days in the IV opioid PCA group; P < 0.0001)
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$2,455 savings in mean per-patient hospitalization costs ($8,271 versus$10,726 for the IV opioid PCA group; P = 0.0109)
“EXPAREL has the potential to change the postsurgical pain management
landscape where narcotics have long been the only effective option,
despite their inherent risks,” said
“The completion of our IMPROVE Phase 4 program marks an important
milestone for the company and EXPAREL,” added
About Pacira
About EXPAREL®
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.
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: our and Patheon’s ability to successfully and timely
construct dedicated EXPAREL manufacturing suites; 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, including
for nerve block and the related timing and success of an sNDA; our plans
to evaluate, develop and pursue additional DepoFoam-based product
candidates; clinical studies in support of an existing or potential
DepoFoam-based product; 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 year ended
Source:
Company Contact:
Pacira Pharmaceuticals, Inc.
Jessica Cho,
973-254-3574
Jessica.Cho@pacira.com
or
Media
Contact:
Pure Communications, Inc.
Susan Heins, 864-286-9597
sjheins@purecommunicationsinc.com