Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, announced that positive results from its phase III 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 multi-centre, 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 Centre, on Tuesday, May 17, 2011 at 11:30 a.m. EDT.
“These phase III 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 III 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 III 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.”
Some of the key findings of the study includes: 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 post-surgical 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.
Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, manufacture and commercialization of novel pharmaceutical products, based on its proprietary DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centres.
Exparel is Pacira's proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anaesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. The most common adverse events following Exparel administration were nausea, constipation, and vomiting.