Pacira Pharmaceuticals, Inc. Announces Receipt of FDA Warning Letter

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the receipt of a Warning Letter (attached for reference) from the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) referencing certain promotional materials on EXPAREL® (bupivacaine liposome injectable suspension). “We take regulatory compliance very seriously and believe that our current labeling supports the claims being challenged by the FDA,” said Dave Stack, president, chief executive officer and chairman of Pacira. “We plan to explain our position to the FDA and will provide an update upon resolution of these issues.” EXPAREL is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia in adult patients 18 years of age or older. About Pacira Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company's current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL® (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com. About EXPAREL® EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours.