Pacira Pharmaceuticals reached an amicable resolution with the United States in a lawsuit filed earlier this year. The resolution confirms the company's bupivacaine liposome injectable suspension product Exparel is broadly indicated for surgical site administration for postsurgical analgesia, but isn't limited to a specific surgery type or site.
"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," said CEO and Chairman of Pacira Dave Stack. "This is especially important given the burgeoning U.S. 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."
Here are five key notes:
1. The lawsuit, Pacira Pharmaceuticals, Inc., et al v. United States Food & Drug Administration et al, was filed on Sept. 8, 2015. The FDA approved Exparel in October 2011 for "administration into the surgical site to produce postsurgical analgesia" in a variety of surgeries.
2. The FDA has approved a labeling supplement amending the Exparel Package Insert to clarify the product isn't limited to a specific surgery type or site as well as the appropriate dosage.
3. The company received a warning letter from the FDA in September 2014, which was formally withdrawn. In the Recission Letter the FDA guidance included information related to infiltration into the transverses abdominis plane and infiltration to produce postsurgical analgesia at the site of oral surgery procedures including tooth extractions.
4. Pacira and the FDA agreed future interactions will be dealt with in an open, forthright and fair manner.
5. Ropes & Gray as well as Latham & Watkins and Lowenstein Sandler represented Pacira in the lawsuit.