Pacira Pharmaceuticals, Inc. (PCRX) Announces Publication Of Pooled Results From IMPROVE Studies Evaluating Health Economic Benefits Of EXPAREL®
6/26/2014 10:13:24 AM
PARSIPPANY, N.J., JUNE 26, 2014 – Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced results from a pooled analysis of IMPROVE, a series of open-label prospective, Phase 4 clinical studies designed to compare postsurgical narcotic use and health economic outcomes associated with EXPAREL® (bupivacaine liposome injectable suspension) as the foundation of a multimodal analgesic regimen versus a standard opioid-based pain management regimen. The analysis, published in this month’s issue of the Journal of Pain Research, concluded that in comparison to the current standard of care, an EXPAREL-based multimodal regimen was associated with significant reductions in opioid consumption, incidence of opioid-related adverse events (ORAEs), length of hospital stay and total hospital costs.
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)
• A $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 Stephen M. Cohen, MD, MBA, FACS, FASCRS, Atlanta Colon and Rectal Surgery, PC, and the lead author of the IMPROVE manuscript. “Building on a solid body of safety and efficacy data, the IMPROVE studies provide quantitative, comparative data on the positive impact of EXPAREL on important pharmacoeconomic benefit measures such as narcotic usage, hospital stay and overall hospital cost. Based on our conclusions, clinicians and hospital administrators should consider transitioning toward narcotic-sparing regimens with EXPAREL as the mainstay for therapy.”
“The completion of our IMPROVE Phase 4 program marks an important milestone for the company and EXPAREL,” added Dave Stack, president, chief executive officer and chairman of Pacira. “Demonstrating the measurable value of EXPAREL to patients and the healthcare system, both independently and in comparison to the standard narcotic-based analgesia, has been our core focus since launch and continues to be an integral lever to increase adoption. In fact, we’re increasingly hearing from surgeons across various specialties collecting their own outcomes data which, similar to IMPROVE, shows a quantifiable impact of replacing narcotics to improve patient care, patient satisfaction and hospital economics.”
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL® (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.
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 December 31, 2013, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Pacira Pharmaceuticals, Inc.
Jessica Cho, (973) 254-3574, Jessica.Cho@pacira.com
Pure Communications, Inc.
Susan Heins, (864) 286-9597, email@example.com
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