Medication Monitor

Generic Name (Trade Name—Company)
October 31, 2011

Bupivacaine liposome injectable suspension

(Exparel—Pacira Pharmaceuticals)
Novel long-acting nonopioid anesthetic/analgesic approved


Management of postsurgical pain

A novel, extended-release 1.3% bupivacaine liposome injectable suspension has been approved by FDA for administration into the surgical site to produce postsurgical analgesia, according to a news release by Pacira Pharmaceuticals. This new product consists of bupivacaine encapsulated in the multivesicular liposome DepoFoam that is designed to extend the duration of analgesia provided by bupivacaine for up to 72 hours. The recommended dose is based on the surgical site and volume required to cover the area.

Approval was based on data from 10 randomized, double-blind clinical trials evaluating the product in 823 patients. In a pivotal hemorrhoidectomy trial, use of bupivacaine liposome injectable suspension demonstrated significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours compared with placebo. The most common adverse events, occurring in 10% or more of patients, following administration were nausea, constipation, and vomiting.