Pacira Release: New Data Demonstrate Reduced Opioid Requirements Following Use Of EXPAREL In Hysterectomy And Mastectomy Procedures

PARSIPPANY, N.J.--(BUSINESS WIRE)--Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced results of two data presentations on the impact of EXPAREL^® (bupivacaine liposome injectable suspension) on postsurgical opioid requirements in patients undergoing hysterectomy or mastectomy. The data were presented during two poster sessions at the annual meeting of the International Anesthesia Research Society (IARS), being held in Honolulu March 21^st-24^th.

“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”

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:

• Significantly decreased total opioid intake in first 72 hours (by 57%)
• Significantly decreased incidence of nausea and vomiting in the first 72 hours (by 32%)
• Significantly lower maximal pain intensity at all time points (0-24 hours, 24-48 hours and 48-72 hours)

“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 Jacob Hutchins, M.D., Minnesota anesthesiologist and the study’s lead investigator. “TAP infiltration provides highly effective incisional pain control, but the limited duration of traditional local anesthetics, such as bupivacaine HCl, still requires a heavy reliance on opioids. Our research found that the benefits of TAP infiltration can be further amplified by using EXPAREL, which provides pain control that more closely matches the time course of the most severe postsurgical pain, thus reducing opioid use and associated adverse events.”

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 Dennis Feierman, M.D., Vice Chairman in the Division of Anesthesiology at Maimonides Medical Center in Brooklyn, NY, found that the patient’s highest pain score in the hospital was a two on a scale of 0-10, and that the patient did not receive any opioids or additional pain medications during her stay or at home. In addition, the patient did not complain of nausea or experience postsurgical vomiting.

“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 Dave Stack, president, chief executive officer, chairman and director of Pacira. “The two studies presented at this year’s IARS annual meeting reinforce that EXPAREL can have a measurable impact on reducing or eliminating the use of opioids, and should play a vital role in opioid-sparing postsurgical pain management protocols.”

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 the United States will become long-term opioid users.^3,4

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.

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 flagship product, EXPAREL^® (bupivacaine liposome injectable suspension), a non-opioid local analgesic for postsurgical pain control, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam^®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

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 of a United States Food and Drug Administration supplemental New Drug Application; our receipt of FDA approval of our nerve block indication; the adverse effects and impacts of FDA warning letters; 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; our and Patheon UK Limited’s ability to successfully and timely construct dedicated EXPAREL manufacturing suites; 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, 2014, 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. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such 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.

References

¹ Adamson, et al. Hosp Pharm. 2011;46(6 Suppl 1):1-3.

² Kessler, E. Richard, et al. “Cost and Quality Implications of Opioid-Based Postsurgical Pain Control Using Administrative Claims Data from a Large Health System: Opioid-Related Adverse Events and Their Impact on Clinical and Economic Outcomes.” Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy 33.4 (2013): 383-391.

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.