FDA approved a new indication for Bupivacaine Liposome injectable suspension (Exparel, Pacira) for use as a nerve block to produce post-surgical regional analgesia following shoulder surgery in adults.
Exparel is intended for use as a nerve block to relieve pain associated with shoulder surgery for a period of 48 to 72 hours following administration. The drug was approved in 2011 for local administration to provide post-surgical analgesia.
“Today’s action helps to fulfill a need for additional nonaddictive pain management tools by providing a new option for certain patients that can last up to 72 hours following surgery,” said Douglas Throckmorton, MD, deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, in a statement from FDA.
However, Exparel’s new use is limited to individuals who will undergo shoulder surgeries. “We are taking careful steps to make sure that healthcare professionals treating pain are armed with this important information about the product’s approved uses as well as its limitations in order to make the best pain management decisions for a patient’s unique needs,” Thockmorton said.
The Interscalene brachial plexus nerve block works by anesthetizing the body’s nerves nearest the shoulder in order to help curb pain.
Exparel’s new indication is being approved based on the results of one multicenter clinical study, which demonstrated that the product is safe and effective for use as an interscalene brachial plexus nerve block to provide post-surgical regional analgesia for shoulder surgeries, such as total shoulder arthroplasty and rotator cuff repair.
FDA determined that clinical trial data is not sufficient to support the general use of Exparel for regional nerve blocks for post-surgical analgesia other than shoulder surgery, according to FDA. “As such, the product’s updated labeling approved today clearly articulates both Exparel’s limitations of use as well as the most up-to-date safety and efficacy data associated with its new interscalene brachial plexus nerve block for post-surgical analgesia indication,” FDA said.