PARSIPPANY, N.J.--(Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the publication of results from a pooled analysis of nine clinical trials across five surgical models that compared cumulative pain scores, opioid consumption and occurrence of opioid-related adverse events (ORAEs) following administration of EXPAREL® (bupivacaine liposome injectable suspension) or bupivacaine HCl. EXPAREL is a non-opioid local analgesic indicated for administration into the surgical site to produce postsurgical analgesia.)--
“This pooled analysis of over 900 clinical trial patients revealed not only improved pain scores with EXPAREL but also a statistical effect on several aspects of the opioid burden, compared to patients randomized to bupivacaine HCl in a multimodal setting”
Notably, the results of the pooled analysis demonstrated that EXPAREL in a multimodal setting was associated with a statistically significant:
- Reduction in cumulative pain scores through 72 hours (P=0.039)
- Longer time to first opioid rescue (P<0.0001)
Decrease in opioid requirements and incidence of ORAEs
- Significant reduction in opioid use (P<0.0001)
- Thirty-six percent of bupivacaine HCl patients experienced at least one ORAE compared to 20 percent of EXPAREL patients (P<0.0001)
“This pooled analysis of over 900 clinical trial patients revealed not only improved pain scores with EXPAREL but also a statistical effect on several aspects of the opioid burden, compared to patients randomized to bupivacaine HCl in a multimodal setting,” said Joseph Dasta, MSc, FCCM, FCCP, RPh, Adjunct Professor at the University of Texas College of Pharmacy, and lead author on the paper. “This EXPAREL-based approach to multimodal pain management, which minimizes exposure to opioids and thus their related adverse events, has the potential to have important economic consequences.”
This analysis pools data from a total of 503 patients who received a single administration of EXPAREL at doses up to 266 mg compared with 409 patients who received bupivacaine HCl at doses up to 200 mg; surgical models included inguinal hernia repair, total knee arthroplasty, hemorrhoidectomy, bunionectomy and breast augmentation. The most frequently reported adverse events in both treatment groups were nausea, constipation and vomiting.
“We are extremely pleased to have the data from this pooled analysis available in the public domain,” said Dave Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. “This analysis allowed us to continue to demonstrate up to 72 hours of pain control with EXPAREL, while also highlighting the product’s significant reduction in opioid requirements compared to bupivacaine HCl. These results are a strong indication of the value of an EXPAREL-based multimodal approach for postsurgical pain management where the goal is to reduce opioid requirements with the hope of mitigating associated adverse events.”
The paper, titled “Bupivacaine Liposome Injectable Suspension Reduces Opioid Burden Compared With Bupivacaine HCl in the Postsurgical Setting” is available in the online version of Current Medical Research and Opinion and will be published in a future print version of the journal.
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is an emerging 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 administration 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 www.EXPAREL.com.