The US Food and Drug Administration (FDA) has approved a supplemental new drug application for bupivacaine liposomal injectable suspension (Exparel, Pacira Pharmaceuticals Inc) for use as an interscalene brachial plexus nerve block to provide regional analgesia following shoulder surgery in adults.
In February, as reported by Medscape Medical News, the FDA Anesthetic and Analgesic Drug Products Advisory Committee voted 6 to 4 against recommending bupivacaine liposomal injectable suspension as a nerve block to treat general regional postsurgical pain.
In line with that recommendation, the FDA has concluded that clinical trial data are “not sufficient” to support the general use of bupivacaine liposomal injectable suspension for regional nerve blocks for analgesia after surgeries other than shoulder surgery.
Therefore, the product’s updated labeling “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,” the FDA said in a news release.
Bupivacaine liposomal injectable suspension was first approved by the FDA in 2011 for administration into the local surgical site to provide postsurgical analgesia.
“The expansion of the Exparel label to now also include interscalene brachial plexus nerve block allows clinicians to potentially eliminate the need for cumbersome catheters and pumps traditionally used to extend the duration of regional analgesia,” the manufacturer said in a news release.
The new indication was granted on the basis of results of a multicenter clinical study, which demonstrated that the agent was safe and effective for use as an interscalene brachial plexus nerve block to provide postsurgical regional analgesia for shoulder surgeries, such as total shoulder arthroplasty and rotator cuff repair, the FDA said.
“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,” Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in the release.
“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,” he added.
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