Pacira Pharmaceuticals, Inc. Announces EXPAREL Data Presentations at the International Anesthesia Research Society 2011 Annual Meeting
Data Highlights Safety, Efficacy for EXPAREL across Multiple Surgical Models
PARSIPPANY, N.J., May 23, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that clinical data highlighting the safety profile of EXPAREL™ (bupivacaine extended-release liposome injection) will be presented at the 2011 International Anesthesia Research Society (IARS) Annual Meeting in Vancouver, British Columbia.
Comprehensive, program-wide safety data for EXPAREL will be presented by Dr. Eugene R. Viscusi, Director, Acute Pain Management, Department of Anesthesiology, Jefferson Medical College, Thomas Jefferson University, on Monday, May 23, 2011 at 2:45 p.m. ET. Dr. Viscusi's presentation, titled "The Safety of EXPAREL™, A Multivesicular Liposomal Extended-Release Bupivacaine" examines the safety profile of EXPAREL in 823 patients across ten wound infiltration studies and five surgical procedures, including hemorrhoidectomy, bunionectomy, total knee arthroplasty, breast augmentation and hernia repair.
Pacira also announced that comprehensive, program-wide efficacy data for EXPAREL was highlighted at IARS. Dr. Sergio Bergese, associate professor of anesthesiology and neurological surgery, The Ohio State University, presented the poster, titled, "The Efficacy of EXPAREL™, A Multivesicular Liposomal Extended-Release Bupivacaine" on Sunday, May 22, 2011 at 8 a.m. ET. The poster was previously presented May 11, 2011 at the Society for Ambulatory Anesthesia (SAMBA) 26th Annual Meeting in San Antonio; this is the first time that the program wide efficacy and safety data have been presented together.
"We are excited to present these data, which support the utility of EXPAREL across multiple surgical models," said David Stack, president and chief executive officer of Pacira Pharmaceuticals. "While EXPAREL was well-tolerated across all doses, based upon clinical experiences to date, we believe 300 mg will be the most commonly used dose. Given the side effect profile observed at this dose, which was comparable to placebo, we believe these data will encourage clinicians to integrate EXPAREL into their pain management treatment paradigms should it be approved by the Food and Drug Administration (FDA) later this year."
Key safety findings from these studies include:
- 823 patients were exposed to EXPAREL at doses from 75 mg to 600 mg across ten wound infiltration studies and five surgical procedures
- Only 32.9% of patients who received EXPAREL at a dose of 300 mg experienced a treatment emergent adverse event (TEAE), compared to 38.9% of patients who received a placebo
- Approximately 62% of all EXPAREL patients experienced a TEAE, compared to 75% of bupivacaine patients
- The most common TEAEs experienced were gastrointestinal in nature, and occurred in approximately 43% of EXPAREL patients, compared to 49% of bupivacaine patients. The most common adverse events were nausea, vomiting and constipation
- TEAEs generally increased with an increasing dose of either bupivacaine or EXPAREL
Key efficacy findings from these studies include:
- 823 patients were exposed to EXPAREL at doses from 75 mg to 600 mg in both soft-tissue and orthopedic models across five surgical procedures: hemorrhoidectomy, bunionectomy, breast augmentations, total knee arthroplasty, and inguinal hernia repair
- EXPAREL demonstrated statistically significant lower pain intensity in the two pivotal trials, with p =0.0005 compared>
- EXPAREL demonstrated a statistically significant lower (p =0.05)>
- Delay in the need for opioids
- Decrease in the amount of opioids required
- Increase in the number of patients able to avoid opioids entirely
For more information or to view the full posters, please visit the scientific presentations page located in the investors and media section on the Pacira website at www.pacira.com.
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 centers. In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL, the company's most advanced investigational product candidate, had been accepted for filing by the U.S. Food and Drug Administration (FDA). 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 a bupivacaine-based product and has completed extensive 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 www.pacira.com.
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 anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Market data indicate that there is an unmet medical need for a longer-acting anesthetic/analgesic for postsurgical pain management. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and suggest statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from Phase 3 trial 316 suggest that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. 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.
Forward Looking Statements
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: the timing of, and our ability to obtain regulatory approval of EXPAREL; the timing of our anticipated commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our commercialization and marketing capabilities; and other factors discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2010, 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.
James S. Scibetta
Chief Financial Officer
Pacira Pharmaceuticals, Inc.
Vice President, Media Relations
Pure Communications, Inc.
SOURCE Pacira Pharmaceuticals, Inc.
Web Site: http://www.pacira.com
Posted: May 2011