With back-to-back PhIII wins, Pacira guns for expanded indication for post-surgery pain drug Exparel
Just weeks after it announced a Phase III win for its pain drug after knee replacement, Pacira BioSciences has posted another Phase III success in post-bunion surgery pain.
In this trial with 185 bunion surgery patients, Exparel significantly reduced cumulative pain scores over a four-day period compared to bupivacaine. It also significantly reduced post-surgery opioid use over the same period compared to bupivacaine — a key secondary metric for pain drugs.
Pacira CEO Dave Stack said in a statement:
With these positive data sets, we believe we are well positioned to broaden the Exparel label to include two additional nerve block indications for prolonged pain management across a wide variety of lower extremity procedures. This will help physicians improve their patients’ outcomes by providing better pain control, while minimizing opioids, accelerating recovery times, and migrating procedures to outpatient settings.
Pacira said it plans to submit an sNDA for Exparel for pain in post-bunion and post-knee replacement surgeries early next year. Exparel is already approved for post-surgery pain relief in the upper body. Exparel takes bupivacaine, a common anesthetic, and puts it into a liposome delivery system, which is supposed to make the pain relief effect last longer, though some independent studies have refuted that claim.
Yesterday, Pacira’s competitor Heron Therapeutics got FDA approval for its IV injection of the generic post-surgery nausea and vomiting drug, aprepitant. Last year, Heron debuted its long-lasting anesthetic Zynrelef as an Exparel alternative, saying it would offer its drug at a lower price.
But Heron hasn’t had it easy — the biotech had to cut a third of its 300 or so employees at the end of June.