May 17, 2011--PACIRA PHARMACEUTICALS, INC. ANNOUNCES PHASE 3 EXPAREL™ DATA PRESENTATION
Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that positive results from its Phase 3 study evaluating EXPAREL™ in patients following hemorrhoidectomy will be presented at the 2011 American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting in Vancouver, British Columbia. Results from this multicenter, randomized, double-blind, parallel-group, placebo-controlled study demonstrated that patients experienced less pain and a reduction in opioid use for 72 hours following a single injection of EXPAREL at the end of the surgical procedure. This is the first time this study data has been presented at a major North American medical meeting. The poster presentation, titled "Extended-Release Multivesicular Liposome Bupivacaine (EXPAREL™) Is Superior to Placebo for Post-Hemorrhoidectomy Pain Reduction," will be presented by Dr. Stephen R. Gorfine, clinical professor of surgery in the Division of Colorectal Surgery at The Mount Sinai Medical Center, on Tuesday, May 17, 2011 at 11:30 a.m. EDT.
"These Phase 3 data demonstrate that the median time to first opioid rescue for patients treated with EXPAREL following hemorrhoidectomy was significantly longer than those treated with placebo," said David Stack, president and CEO of Pacira Pharmaceuticals. "Patients in this study underwent excisional hemorrhoidectomy using the Milligan-Morgan technique, a painful soft tissue surgery. We believe that these data coupled with our positive Phase 3 data from our bunionectomy trial will help support the potential utility of EXPAREL in a clinical setting and build important mindshare among key opinion leaders. This is the first time that these Phase 3 data are being presented at a North American medical meeting and we believe this is another important milestone as we execute on our clinical and pre-commercial strategies."
Key findings from this study include:
The study met its primary endpoint with a statistically significant reduction in cumulative pain score in patients receiving EXPAREL compared to placebo (p<0.0001).
A total of 189 patients were treated at 12 clinical sites in Europe.
The percentage of patients who were entirely opioid free was higher (p<0.0008) with EXPAREL than with placebo.
The median time to first opioid rescue was 14 hours and 20 minutes in the EXPAREL group, more than 10 times longer than the placebo group (1 hour and 10 minutes) (p<0.0001).
EXPAREL patients consumed statistically significantly less opioid rescue medication through 72 hours compared to the placebo group (p=0.0006).
In addition, the study showed that EXPAREL was well tolerated, with the incidence of adverse events (AEs) similar to placebo. GI side effects, commonly associated with opioid use, were reduced in the EXPAREL group compared to placebo, and there were no serious adverse events (SAEs) reported in patients receiving EXPAREL. Overall, 94.7% of patients treated with EXPAREL were "satisfied" or "extremely satisfied" with their postsurgical analgesia at 72 hours compared with 73.9% in the placebo group (p<0.0007).
There were no deaths or withdrawals due to an AE in the study. There was one SAE (mild thrombophlebitis), which occurred in a patient who had received placebo, and was resolved the next day after treatment. The most common AEs experienced were gastrointestinal in nature, occurring in 8.4% of EXPAREL patients and 13.8% of placebo patients.
For more information or to view the full poster, please visit the scientific presentations page located in the investors and media section on the Pacira website at Pacira Pharmaceuticals, Inc.
. PR-USA.net - Pacira Pharmaceuticals, Inc. Announces Phase 3 EXPAREL™ Data Presentation at the American Society of