Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, has launched Exparel (bupivacaine liposome injectable suspension) in the United States.
According to a company release, Exparel will begin shipping to hospital and ambulatory care customers through their normal wholesaler and distributor channels. Exparel was approved by the US Food and Drug Administration (FDA) in October 2011 for administration into the surgical site to produce postsurgical analgesia.
Strong pre-launch commercialization efforts including more than 40 data publications and more than 1,700 interactions with potential customers have laid the groundwork for what Pacira believes will be the successful introduction of Exparel into the hospital marketplace.
Exparel (bupivacaine liposome injectable suspension) is indicated for administration 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. Pivotal studies have demonstrated the safety and efficacy of Exparel in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures.
“For Pacira, today is the culmination of several important organizational milestones that span the last several years, with the most significant being the FDA approval of Exparel,” said Dave Stack, president and CEO of Pacira Pharmaceuticals. “For the millions of patients undergoing surgical procedures in the US each year, the introduction of Exparel—a single-dose, non-opioid local analgesic given at the close of surgery—represents a significant addition to the armamentarium of currently available options to manage postsurgical pain.”
The Pacira sales force, which consists of 63 hospital specialists who cover more than 81 percent of the market Pacira is targeting for Exparel, was launched in January 2012. Since that time, this team has been executing a formulary access strategy, working closely with key hospital and surgical customers to initiate the formulary review process to obtain access for Exparel.
“Through the work of our field force and the commercialization activities executed to date, awareness and anticipated demand for Exparel has continued to grow among our target markets,” said Taunia Markvicka, PharmD, vice president, commercial. “We intend to build off that momentum through a targeted strategy in 2012 that encompasses phase 4 clinical research, partnerships with key hospital customers and robust publication and medical education plans.”
Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients.