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  • Exparel Resolution of FDA Legal Action




    Dear Health Care Provider,


    As you may be aware, Pacira Pharmaceuticals, Inc. has been in ongoing settlement discussions with the U.S. Food and Drug Administration (FDA) related to a Warning Letter issued in September 2014.


    Today, we are pleased to announce that Pacira has reached an amicable resolution with the FDA, which reaffirms that EXPAREL® (bupivacaine liposome injectable suspension) is broadly indicated for use in a variety of surgeries not limited to bunionectomy or hemorrhoidectomy.


    The FDA has approved a labeling supplement which amends the EXPAREL Package Insert (PI) to clarify and reinforce that the use, efficacy and safety of EXPAREL is not limited to any specific surgery type or site. Significant revisions include:


    Section 2. Dosage and Administration: Revised language to indicate the proper dosage and administration of EXPAREL and provide examples based on various patient and procedure-specific factors

    Section 14.2 Study 2: Clarified that there was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy study

    Section 2.2 Compatibility Considerations: Provided guidance that EXPAREL may be admixed with bupivacaine HCl—including co-administered in the same syringe—provided certain medication ratios are observed

    The September 2014 Warning Letter has been formally withdrawn via a Rescission Letter from Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) to Pacira CEO Dave Stack.


    At the request of Pacira, this letter includes FDA guidance related to two key procedures:


    Infiltration into the transversus abdominis plane (TAP), which is a field block technique covered by the approved indication for EXPAREL


    Infiltration to produce postsurgical analgesia at the site of oral surgery procedures including tooth extractions, which is also covered by the approved indication for EXPAREL


    This resolution allows the Pacira team to place renewed focus on the important task at hand—collaborating with hospitals and healthcare professionals to ensure as many patients as appropriate have access to non-opioid medications, like EXPAREL, in order to reduce opioid exposure and improve the postsurgical recovery experience.


    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.


    We thank the FDA for the productive collaboration to resolve this matter in an expeditious and meaningful way, and we look forward to working with you—our customers—to continue to carry out the Pacira mission to improve patient care.


    For additional information related to the resolution, please visit the Legal Resolution section of the Pacira website.


    Best regards,


    James B Jones, MD, PharmD, FACEP
    James B Jones, MD, PharmD, FACEP
    Senior Vice President & Chief Medical Officer
    Pacira Pharmaceuticals, Inc.


    EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.


    Important Safety Information


    EXPAREL is contraindicated in obstetrical paracervical block anesthesia
    EXPAREL has not been studied for use in patients younger than 18 years of age
    Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL
    Monitoring of cardiovascular and neurological status as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products
    Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations
    In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting
    PP-EX-US-1234