April 6, 2018
"The FDA recognizes that judicious treatment of pain requires access to a broad range of medical products. While we are committed to making safe and effective pain management tools available, including nonaddictive options, it’s important that those considering use of such products also have access to balanced, factual information on their risks, benefits, and appropriate uses,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “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; however, its new use is limited to individuals who will undergo shoulder surgeries. We are taking careful steps to make sure that health care 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."
The U.S. Food and Drug Administration today approved a new indication for Exparel (bupivacaine Liposome injectable suspension) for use as an interscalene brachial plexus nerve block to produce post-surgical regional analgesia following shoulder surgery in adults. Interscalene brachial plexus nerve block works by anesthetizing the body’s nerves nearest the shoulder in order to help curb pain. 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.
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. In accordance with recommendations made by an FDA advisory committee in February, the agency has 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. 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.
In 2011, Exparel was approved for local administration to provide post-surgical analgesia. The FDA is granting approval for Exparel’s new indication for use in interscalene brachial plexus nerve block for post-surgical analgesia for shoulder surgery to Pacira Pharmaceuticals Inc.
- FDA: February 14-15, 2018 Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
- FDA Blueprint: Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain
- NIH: Interagency Pain Research Coordinating Committee
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.