WASHINGTON -- The FDA has approved the non-opioid analgesic bupivacaine liposome injectable suspension (Exparel) for use in postsurgical pain relief.
The 1.3% solution delivers extended pain relief through a liposomal platform, called DepoFoam, that allows the drug to be administered into the surgical site, producing postsurgical analgesia for up to 72 hours, according to Pacira Pharmaceuticals.
Conventional bupivacaine, the longest-acting local anesthetic/analgesic on the market, provides therapeutic benefits for only seven hours or less, the drug maker added.
The multivesicular liposome local anesthetic is the first that can be used after surgery like other current local anesthetics, the company stated.
Drug safety was established through 21 clinical trials of more than 1,300 patients, including 10 in which the suspension was administered through local surgical-site injections, in amounts ranging from 66 mg to 532 mg.
In one key hemorrhoidectomy study, patients receiving opioids for pain relief were treated with bupivacaine liposome injection, after which they showed significant cumulatively reduced pain scores versus placebo and decreased opioid consumption for up to 72 hours, the statement said.
The most common adverse events were nausea, constipation, and vomiting.
The drug is contraindicated in obstetrical paracervical block anesthesia.
Patients receiving this drug should not take another formulation of bupivacaine for 96 hours.