News Release

New Study Correlates Use of EXPAREL for Postsurgical Pain Management with Significant Reductions in Opioid Related Adverse Events

--Data from American College of Surgeons Demonstrates Reduced Incidence of Respiratory Depression, Urinary Retention and Fall Risk in Patients Receiving EXPAREL--

PARSIPPANY, N.J.--(BUSINESS WIRE)--Oct. 27, 2014-- Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced results of an independent, physician-initiated study that reinforce the positive impact of an EXPAREL-based pain management regimen on reducing postsurgical complications associated with opioid use. The data, presented at the American College of Surgeons (ACS) Clinical Congress, found that patients treated with EXPAREL experienced statistically significantly lower rates of urinary retention, respiratory depression and fall risk compared to their counterparts who received the previous standard of care (SOC). The ACS Clinical Congress is being held October 26-30 at the Moscone Center in San Francisco.

“Owed largely to their potency, opioids have been the cornerstone of postsurgical pain management despite inherent risks and side effects which can delay the recovery process and pose substantial patient safety issues,” said Jay Redan, M.D., FACS, Medical Director of Minimally Invasive General Surgery at Florida Hospital Celebration Health and the study’s lead investigator. “Our findings suggest that including EXPAREL in a multimodal analgesic regimen can reduce the occurrence of opioid-related adverse events, and is associated with statistically significant reductions in urinary retention, respiratory depression and risk of falls after surgery.”

The study evaluated 82 patients undergoing open ventral hernia repair or laparoscopic colon resection, all of whom were treated by Dr. Redan. Thirty-seven patients received the SOC: intravenous hydromorphone or morphine with or without epidurals and/or IV acetaminophen. The other 45 patients received infiltration with EXPAREL in addition to the SOC. Key findings include:

  • Patients in the EXPAREL group experienced statistically significant reductions in the incidence of:
    • Urinary retention (0% in the EXPAREL group vs 10.8% in the SOC group; P<0.05)
    • Respiratory depression (2.2% in the EXPAREL group vs 21.6% in the SOC group; P<0.05)
  • Use of EXPAREL resulted in a statistically significant reduction (P<0.001) in the amount of patients classified as being “high-risk” for falls (8.4% in the EXPAREL group vs 16% in the SOC group) and an increase in patients classified as being “low-risk” for falls (48.7% in the EXPAREL vs 37.6% in the SOC group), according to the Morse Fall Scale designed to predict falls, and assess and address risk factors contributing to fall risk.

“Our ability to demonstrate the measurable impact of adding EXPAREL to our postsurgical pain management protocol played a major role in driving formulary acceptance of the product and increasing adoption across various surgical disciplines,” added Dr. Redan. “Based on my data and clinical experience, adopting a low-opioid strategy using EXPAREL not only reduces ORAEs and improves the patient recovery process, but has the potential to positively impact institutional efficiencies and economics as well as patient outcomes.”

EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.

About Pacira

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.

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 significant reductions in cumulative pain scores with a 45% 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 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: 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.

Source: Pacira Pharmaceuticals, Inc.

Company:
Pacira Pharmaceuticals, Inc.
Jessica Cho, 973-254-3574
Jessica.Cho@pacira.com
or
Media:
Pure Communications, Inc.
Susan Heins, 864-286-9597
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