Pacira rockets on favorable Exparel ruling from FDA

USA-based Pacira Pharmaceuticals (Nasdaq: PCRX) saw its shares leap 15.33% to $72 in early afternoon trading on Tuesday after the US Food and Drug Administration U-turn, allowing the company to market its post-surgical analgesia treatment as not being limited to a specific surgery.

The resolution confirms that the company’s flagship product Exparel (bupivacaine liposome injectable suspension) is, and has been since 2011, broadly indicated for administration into the surgical site to provide postsurgical analgesia. The resolution will allow Pacira to promote its treatment for a wide variety of surgeries, beyond the two it has been tested on, bunion and hemorrhoid surgeries.

“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,” stated Dave Stack, chief executive and chairman of Pacira. “This is especially important given the burgeoning US opioid epidemic, underscored by the reality that one in 15 patients will go on to long-term use after receiving an opioid in the hospital setting,” he noted.