Pacira Pharmaceuticals faced a setback as FDA advisers did not support the extended use of its pain therapy Exparel as a nerve block after surgery. The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 6-4 against the approval of Exparel (bupivacaine liposome injectable suspension) for this new use. Although the vote is not binding, the FDA typically follows the advice of its experts.
Exparel, a new formulation of a well-established generic non-opioid painkiller, has been approved since 2011 for treating pain in patients undergoing bunion or hemorrhoid removal. Pacira aimed to expand its use based on mixed study results, which indicated effectiveness as a nerve block in the thigh but not between the ribs. The company also seeks to adjust the wording of Exparel's current indication to align with current clinical practices.
Despite submitting two new studies aimed at addressing the FDA's original concerns regarding knee and shoulder surgery, FDA staff reviewers remain concerned about some pharmacology results and the drug's neurologic safety. However, new data did not reveal any evidence of cardiac toxicity, a previous concern.
With a decision on the new use expected in early April, there are concerns that the FDA may reject Exparel's extended use again. This comes as the FDA is actively seeking non-opioid painkillers and analgesics to avoid the potential for addiction. Dave Stack, chairman and CEO of Pacira Pharmaceuticals, expressed the company's commitment to working with the FDA to address any remaining questions and to expand the administration options for Exparel to benefit clinicians and patients seeking long-lasting non-opioid pain control.
