Pacira CEO Dave Stack discussed the company's efforts to expand its nerve block Exparel label in an emailed interview with pharmaphorum.
Here are five insights.
1. Exparel, a bupivacaine liposome injectable suspension, was approved as a nerve blocker for removal of bunions and haemorrhoids. In February, a FDA adviser committee voted down a label extension for the drug. Despite this vote, the FDA decided to expand the label to cover it as a nerve block for shoulder surgery.
2. Even though Pacira earned a victory with the expansion to shoulder surgery, Mr. Stack said there is a still a ways to go to receive approval for Exparel's use in other surgeries. Literature supporting Exparel notes the drug is usable in thoracotomy, total knee arthroplasty and hand, wrist, foot and ankle surgeries.
3. Mr. Stack said the company is focused on jumpstarting conversations with the FDA again to expand the label, despite the agency rejecting trial evidence for knee surgery submitted this year. The FDA had concerns about pharmacology results and the drug's neurologic safety.
4. Mr. Stack shared the trial data revealed Exparel reduced opioid use by 78 percent, with 13 percent of patients opting out of all opioids after shoulder surgery.
5. As a non-opioid generic drug for pain relief, Exparel will cost about $285 per vial. Mr. Stack told pharmaphorum, "In terms of commercialization for the new indication, our initial efforts will center on accounts that both have Exparel access and perform regional nerve blocks."