Pacira Pharmaceuticals, Inc. has “made nice” with the FDA. The company has, according to the December 15, 2015 news release, “achieved an amicable resolution with the United States in its lawsuit (filed on September 8, 2015). The resolution confirms that EXPAREL (bupivacaine liposome injectable suspension) is, and has been since 2011, broadly indicated for administration into the surgical site to provide postsurgical analgesia.”
“In September 2014, the FDA Office of Prescription Drug Promotion issued Pacira a Warning Letter related to certain promotional materials.” That letter has officially been formally withdrawn via a “Rescission Letter.”
“We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate, ” stated Dave Stack, CEO and chairman of Pacira. “This is especially important given the burgeoning U.S. opioid epidemic, underscored by the reality that one in 15 patients will go on to long-term use after receiving an opioid in the hospital setting.”
Asked what was especially challenging about this Warning Letter/legal) process, Stack told OTW, “The most challenging aspect of this process was our hampered ability to educate surgeons about important considerations related to the recommended administration technique with EXPAREL to achieve optimal results. We’ve learned that the total volume to which EXPAREL is expanded, the use of appropriate adjunctive medications, and the adequate distribution of EXPAREL throughout the surgical site and neuroanatomy are key factors in achieving optimal results, particularly in orthopedic procedures such as total knee arthroplasty. If any of those factors are overlooked, there is an increased potential for patients to receive suboptimal pain relief.”
“There are a few significant takeaways from this resolution agreement. First, the FDA has officially withdrawn the Warning Letter issued in September 2014 and reaffirmed that EXPAREL is, and always has been, broadly approved for “administration into the surgical site to produce postsurgical analgesia” in a variety of surgeries not limited to those studied in pivotal trials. Second, significant changes to the EXPAREL Package Insert were made to help clarify the broad indication for EXPAREL, and—of specific importance to orthopedic surgeons—the FDA has provided guidance on admixing EXPAREL with bupivacaine HCl, which should help further optimize treatment outcomes. We are quite pleased with the outcome of this successful collaboration with the FDA and look forward to a renewed focus on engaging with healthcare providers to advance patient care.”
