Phase 3 Study of Exparel for Postsurgical Pain

Pacira Pharmaceuticals announced data from its Phase 3 study of Exparel (bupivacaine extended-release liposome injection) for the treatment of postsurgical pain after augmentation mammoplasty, the most commonly performed plastic surgery procedure in the United States. A total of 136 patients were treated; when their pain score and opioid usage were combined using the integrated rank analysis of Silverman, statistical significance was achieved at multiple time points (P<0.05). The mean total amount of opioid rescue used (morphine equivalents) was lower with Exparel at all time points through 96 hours; the difference between groups was statistically significant for the time intervals of 0–24 hours and 0–48 hours.

Exparel consists of bupivacaine encapsulated in DepoFoam, both of which are currently used separately in FDA-approved products. Exparel is a novel long-acting, sustained-release analgesic formulation of bupivacaine HCl being developed for prolonged postoperative analgesia.

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