Amicable resolution between FDA and Pacira Pharmaceuticals, Inc., which reaffirms the broad indication for Exparel (bupivacaine liposome injectable suspension).
An amicable resolution has been reached between FDA and Pacira Pharmaceuticals, Inc., which reaffirms the broad indication for Exparel (bupivacaine liposome injectable suspension).
Exparel is the first and only multivesicular liposome local anesthetic that can be used in the peri- or post-surgical setting to produce postsurgical analgesia. Exparel is a combination of bupivacaine, an amide local anesthetic, and DepoFoam, a delivery technology that allows the drug to be delivered over time. Using this delivery system, Exparel offers reductions in cumulative pain score with a decrease in opioid consumption.
In September 2014, the FDA Office of Prescription Drug Promotion (OPDP) issued Pacira Pharmaceutical, Inc. a Warning Letter related to certain promotional materials for Exparel. Pacira quickly sought a court order to defend against retroactive attempts to limit the broad indication and restrict communication supported by the approved label.
The 2 parties recently reached a resolution in which FDA confirmed that Exparel has, since its approval on October 28, 2011, been approved for administration into the surgical site to provide postsurgical analgesia for use in a variety of surgeries not limited to those studied in its pivotal trials.
"Our amicable resolution with the FDA is important because it removes the restrictions placed by the 2014 Warning Letter and reaffirms our right to inform healthcare professionals, formulary managers and administrators about the use of Exparel across various surgeries," said Dave Stack, Pacira's chief executive office and chairman, in a statement to FormularyWatch. "Most importantly, it allows us to appropriately educate surgeons about the proper use and administration of Exparel to achieve optimal patient outcomes. We are pleased with the result of this successful collaboration with the FDA to remove any ambiguity regarding the [drug's] package insert and look forward to a renewed focus on engaging with healthcare providers to advance patient care.”
Additionally, according to Stack, FDA clarified that there was a significant 72-hour treatment effect for Exparel compared to placebo in the pivotal soft-tissue trial, and the revised label now includes information about median time to first opioid use and percentage of patients who were opioid free in each group.
"The opioid reduction seen with Exparel is especially important given that 1 in 15 patients will go on to long-term use after receiving an opioid in the hospital setting,” he said.
FDA also approved a labeling supplement to amend the Exparel package Insert to clarify and reinforce the use, efficacy and safety of Exparel. The proper dosage and administration of Exparel is based on various patient- and procedure-specific factors. Additionally within this labeling supplement, Exparel may be admixed with bupivacaine, provided certain medication ratios are observed.