Pacira resolves warning letter with FDA’s Office of Prescription Drug Promotion
Pacira Pharmaceuticals recently announced it has resolved issues regarding certain promotional aspects of Exparel, its bupivacaine liposome injectable suspension product, which led to a warning letter from the FDA’s Office of Prescription Drug Promotion in September 2014.
According to a company press release, in the resolution Pacira acknowledged Exparel is broadly indicated for administration into the postsurgical site to produce postsurgical analgesia in hemorrhoidectomy and bunionectomy as FDA approval was based on pivotal trials conducted in these surgical models. Thus, the basis for assessment of safety and efficacy was limited to those two procedures.
The company also acknowledged Exparel demonstrated a significant reduction in pain intensity scores compared with placebo for up to 24 hours in both pivotal trials. In the hemorrhoidectomy trial, which had a primary endpoint of cumulative pain scores over the first 72 hours, there was minimal to no difference in pain intensity scores between Exparel and placebo from 24 hours to 72 hours. However, there was a cumulative decrease in opioid consumption through 72 hours. The clinical benefit of that reduction was not demonstrated, according to the release.
“We are pleased to have reached a mutually acceptable resolution with the Office of Prescription Drug Promotion regarding the matters raised in the warning letter,” Dave Stack, president, CEO and chairman of Pacira, stated in the release. “In the face of our nation’s burgeoning opioid abuse epidemic, we continue to believe that Exparel plays a critical role in reducing our reliance on and overuse of opioids in the acute care setting by providing a viable non-opioid alternative.”
According to the release, Pacira is actively working to ensure its sales force and other promotional channels communicate these points to customers thoroughly and accurately.