The US Food and Drug Administration today approved a novel long-acting nonopioid anesthetic/analgesic for postsurgical pain: bupivacaine extended-release liposome injection (Exparel, Pacira Pharmaceuticals).
Exparel consists of bupivacaine encapsulated in the multivesicular liposome DepoFoam, Pacira Pharmaceutical's extended drug-delivery technology that is the basis for 2 products already on the market: DepoCyte (cytarabine liposome injection) and DepoDur (morphine sulfate extended-release liposome injection).
The new product is designed to extend the duration of analgesia provided by bupivacaine. Based on clinical trial data, Exparel provides continuous and extended postsurgical analgesia for up to 72 hours compared with bupivacaine's analgesic time of 7 hours or less, the company notes.
Exparel has been shown safe in more than 1300 patients across 21 studies, the company says. Most recently, the product was shown to be safe and effective in 2 multicenter, randomized, double-blinded, placebo-controlled, pivotal phase 3 clinical trials in patients undergoing hemorrhoidectomy and bunionectomy.
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