Pacira Pharmaceuticals Highlights Additional Safety Data on EXPAREL(TM) for Postsurgical Pain Relief at 2011 American Academy of Orthopaedic Surgeons Annual Meeting
EXPAREL Well Tolerated and Did Not Adversely Impact Wound Healing;
Poster Selected as Meeting's Best in 'Foot and Ankle' Category
SAN DIEGO, and PARSIPPANY, N.J., Feb. 15, 2011 /PRNewswire via COMTEX/ -- Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that additional safety data are being highlighted from its Phase 3 trial of EXPAREL(TM) (bupivacaine extended-release liposome injection) in bunionectomy. The data showed comparable safety in wound healing and significantly improved efficacy in pain reduction compared to placebo. These results are being highlighted in a poster presentation at the 2011 American Academy of Orthopaedic Surgeons Annual Meeting in San Diego, Calif.
"Data show that EXPAREL did not alter wound healing and no patients experienced malunion or non-union, both of which are critical factors considered when used to determine the appropriate postsurgical analgesic therapy," said Eugene R. Viscusi, M.D., Director, Acute Pain Management, Department of Anesthesiology, Jefferson Medical College, Thomas Jefferson University, Philadelphia. "These data, coupled with efficacy data, demonstrate that a single administration of EXPAREL enabled more patients to be pain-free for up to 48 hours post surgery, and significantly delayed usage of, or decreased the need for opioid rescue medication. These overall findings support that EXPAREL may be a useful addition to postsurgical analgesic."
The multicenter, parallel-group, randomized, double-blind study of 193 patients evaluated the efficacy and safety of the intraoperative administration of EXPAREL compared with placebo in bunionectomy patients. The company reported preliminary efficacy data in October 2009, and presented updated efficacy data during the Orthopaedic Research Society meeting (January 2011). These study results include:
• Statistically significantly more patients treated with EXPAREL were pain-free at 2, 4, 8 and 48 hours compared to placebo (p<0.05) and statistically significantly less opioids were consumed
- The median time to first use of opioid rescue medication was 7.2 hours for patients treated with EXPAREL compared with 4.3 hours for patients treated with placebo (p<0.0001)
- A larger percentage of patients treated with EXPAREL avoided any opioid rescue medication during the first 24 hours after surgery compared to placebo (7% vs.1%; p<0.05)
- EXPAREL was well tolerated in patients who received postsurgical treatment for pain following bunionectomy
- There were no statistically significant differences between treatment groups in wound assessments (erythema, drainage, edema, and in duration)
- No patients demonstrated any evidence of malunion or non-union. Follow-up radiographs and documentation of wound healing were collected for 82% of patients four to six weeks post bunionectomy procedures
- The incidence of adverse events was lower in the EXPAREL group (60%) than in the placebo group (68%); the most common events in both groups were nausea, vomiting, and dizziness
"EXPAREL addresses an unmet need in postsurgical pain control, which is the need for a longer-lasting, non-opioid analgesic," said David Stack, president and chief executive officer, Pacira Pharmaceuticals, Inc. "We believe these findings along with previously reported efficacy data continue to differentiate EXPAREL."
"Based upon the findings of this Phase 3 study, we believe Pacira's DepoFoam(R) technology enables EXPAREL to safely and effectively extend the duration of pain relief by more than 67% compared with placebo," added Stephen Daniels, D.O., primary study investigator and executive medical director, Premier Research Group Limited, Austin, Texas. "EXPAREL has the potential to be the first FDA-approved long-acting bupivacaine analgesic and should be well positioned to support a standard postsurgical treatment regimen. In addition, EXPAREL's ease-of-use should allow medical professionals to seamlessly incorporate its use into their existing medical practices."
In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL had been accepted for filing by the U.S. Food and Drug Administration (FDA). Pacira submitted the EXPAREL NDA in September 2010 for the initial indication of postsurgical analgesia by local administration. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 28, 2011 for the review of the EXPAREL NDA.
EXPAREL is Pacira's proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam(R), both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and demonstrate statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data has also demonstrated that EXPAREL provides analgesia for up to 72 hours post-surgery compared with 7 hours or less for bupivacaine. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical wound clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.
Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, commercialization and manufacture of novel pharmaceutical products, based on its proprietary DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. The company's most advanced investigational product candidate, EXPAREL, a bupivacaine-based product, has completed Phase 3 clinical development for postoperative analgesia by infiltration.EXPAREL consists of bupivacaine encapsulated in DepoFoam, which is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. Additional information about Pacira is available at http://www.pacira.com/.
Any statements in this press release about our future expectations, plans and prospects, including statements about EXPAREL's potential, and other statements containing the words "believes," "anticipates," "plans," "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: our ability to successfully obtain regulatory approval for EXPAREL; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses and our ability to raise substantial additional funds to achieve our goals; general economic and industry conditions; and other factors discussed in the "Risk Factors" section of the final prospectus relating to our initial public offering filed with the Securities and Exchange Commission, 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. 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.