Pacira to present EXPAREL data in postsurgical pain at two medical meetings

Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that clinical and preclinical data highlighting the safety and efficacy of EXPAREL™ will be presented at two medical meetings.

New Phase 3 data on the use of EXPAREL in the treatment of postsurgical pain after augmentation mammoplasty will be presented by Sergio Bergese, M.D., associate professor of anesthesiology and neurological surgery, The Ohio State University, at the Society for Ambulatory Anesthesia (SAMBA) 26th Annual Meeting in San Antonio on Saturday, May 7, 2011. Dr. Bergese's presentation, titled "EXPAREL™ (Bupivacaine Extended-Release Liposome Injection), An Investigational Analgesic, Provides Postsurgical Pain Relief and Decreased Opioid Use as Demonstrated by Integrated Analysis" evaluated the extent and duration of the analgesic effect of EXPAREL in patients undergoing augmentation mammoplasty, the most commonly performed plastic surgery procedure in the United States.

Key findings from this study include:

  • A total of 136 patients were treated at 11 clinical sites in the U.S.
  • When the pain score and the opioid usage were combined using the integrated rank analysis of Silverman, statistical significance was achieved at multiple time points (p<0.05)
  • The mean total amount of opioid rescue used (morphine equivalents) was lower with EXPAREL at all time points through 96 hours
    • The difference between groups was statistically significant for the time intervals of 0–24 hours and 0–48 hours
  • The overall incidence of treatment-emergent adverse events was approximately 73% in both treatment groups
  • There were no serious adverse events, deaths or withdrawals from the study due to an adverse event in either treatment group

"We are amassing a comprehensive body of evidence that we believe supports the utility of EXPAREL," said David Stack, president and CEO of Pacira Pharmaceuticals. "We are excited to present these new Phase 3 data that favor EXPAREL, including a decrease in the use of opioid rescue medication and improvement of patient satisfaction with non-opioid analgesia. We have thoughtfully built a clinical program focused on obtaining data that will illustrate the utility of EXPAREL within the clinical community and we believe the effective execution of this strategy will encourage rapid adoption for EXPAREL if approved later this year."

Dr. Bergese is also presenting comprehensive, program-wide efficacy and safety data for EXPAREL as demonstrated across numerous Phase 2 and Phase 3 clinical trials.  The presentation, also at SAMBA on Saturday, May 7, 2011, is titled, "The Efficacy of EXPAREL™, A Multivesicular Liposomal Extended-Release Bupivacaine."

Pacira also announced that new Phase 1 and preclinical data on EXPAREL, as well as previously presented preclinical data, will be highlighted at the American Society of Regional Anesthesia and Pain Medicine (ASRA) 36th Annual Regional Anesthesia Meeting and Workshops, May 5-8, 2011 in Las Vegas.

  • "Duration of Motor vs. Sensory Blockade of EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) and Bupivacaine HCl in a Phase 1 Epidural Study" (Presented by Eugene R. Viscusi, M.D., Director, Acute Pain Management, Department of Anesthesiology, Thomas Jefferson University)
  • "Safety and Tolerability of DepoFoam® Encapsulated Bupivacaine for Intra-articular use in Rabbits and Dogs"
  • "Safety Evaluation of DepoFoam® Encapsulated Bupivacaine in Dogs to Assess Inadvertent Intrathecal Injection"
  • "DepoFoam® Encapsulated Bupivacaine Technology – Safety and Tolerability Properties in Rabbits and Dogs"
  • "The Safety Evaluation of DepoFoam® Encapsulated Bupivacaine Administered by Epidural Nerve Block in Rats and Dogs"

SOURCE Pacira Pharmaceuticals, Inc.

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