Efficacy of EXPAREL® in Clinical Trials

The efficacy of EXPAREL was evaluated in two pivotal Phase 3 studies. Both investigations were multicenter, randomized, double-blind, placebo-controlled trials.1,2

Significant long-lasting pain control in a clinical trial of patients undergoing a soft tissue surgery3

Primary endpoint: cumulative pain score reflected in area under the curve (AUC) of numeric rating scale (NRS) through 72 hours3

  • 30% reduction in cumulative pain scores vs placebo (P<0.0001)1,3

Pain intensity scores (NRS)

  • Significant reduction in pain intensity scores vs placebo during first 24 hours3
Reduction in Cumulative Pain & Opioid Consumption
  • By 24 hours, 88% of patients in the placebo group vs 64% of patients in the EXPAREL group (P<0.0008) were rescuing with opioids, causing the differences between the treatment groups for pain intensity scores to diminish for the rest of the study period3

Significant decrease in opioid consumption in a clinical trial of patients undergoing a soft tissue surgery1,3,*

  • 45% reduction in overall opioid consumption** vs placebo through 72 hours (P<0.0006)3
  • 28% of patients in the EXPAREL group did not require any rescue medication throughout the 72-hour study period vs 10% of patients in the placebo group. (P<0.0008)1
EXPAREL Opioid Use Versus Placebo
  • Significant 14-hour difference in median time to first opioid rescue between treatment groups

*The clinical benefit of the difference in opioid consumption was not demonstrated in the clinical trials.

**Opioid reduction calculated based on geometric mean ratio; P≤0.0006.

Soft-tissue trial design1,3

Phase 3 trial of patients undergoing a 2- or 3-column excisional hemorrhoidectomy (N=189) randomized to receive a single administration of 266 mg of EXPAREL or placebo for postsurgical analgesia. Primary endpoint was cumulative pain scores as reflected in the AUC of NRS through 72 hours. Placebo was preservative-free saline for injection. Opioid rescue medication (up to 10 mg IM morphine) was available to all patients.

 

Soft Tissue Pivotal Trial: Hemorrhoidectomy

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Important Notice

This site is for informational purposes only and is intended to address medical questions from healthcare professionals in the United States.

To report an adverse event, e-mail drugsafety@pacira.com or dial 1-855-RX-EXPAREL (1-855-793-9727).

For medical inquiries related to EXPAREL, submit a request to Medical Information or call 1-855-RX-EXPAREL (1-855-793-9727).

These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.

References

  1. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559.
  2. Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011;28(9):776-788.
  3. Data on file. Parsippany, NJ: Pacira Pharmaceuticals, Inc.; May 2016.

Important Safety Information

Warnings and Precautions Specific to EXPAREL

Warnings and Precautions for Bupivacaine-Containing Products

Please refer to full Prescribing Information.

Important Safety Information

Medical Information

US healthcare professionals Click Here

Non-US healthcare professionals can submit a request to medinfo@pacira.com

If you are not a healthcare professional, please discuss any questions you have regarding your health or treatment with your physician, pharmacist, nurse, or other healthcare professional.

Important information about EXPAREL®

The FDA confirms that EXPAREL has always been approved for "administration into the surgical site to produce postsurgical analgesia" for use in a variety of surgeries not limited to those studied in its pivotal trials.

"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."

- Dave Stack, Chief Executive Officer and Chairman of Pacira

The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.

Important Safety Information

  • EXPAREL is contraindicated in obstetrical paracervical block anesthesia
  • In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting
  • EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients
  • 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

Warnings and Precautions Specific to EXPAREL

  • EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use
  • 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

Warnings and Precautions for Bupivacaine-Containing Products

  • Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesias. CNS reactions are characterized by excitation and/or depression
  • Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias sometimes leading to death
  • Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients
  • Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use

Please refer to full Prescribing Information.

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