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Postsurgery Painkiller Exparel (Bupivacaine) Effective in Late-Stage Trial
FDA filing expected soon (February 27)
A pivotal phase III trial assessing the safety and efficacy of Exparel (bupivacaine liposome injectable suspension) in femoral nerve block for total knee arthroplasty has met its primary efficacy endpoint.
The study evaluated 183 patients who were randomly assigned to receive either Exparel 266 mg or placebo, with all patients offered rescue narcotics as needed. The results demonstrated statistical significance (P < 0.0001) in favor of Exparel for cumulative pain scores over 72 hours, as measured by the area under the curve (AUC). The preliminary safety analysis was comparable between the two groups.
According to the product’s developer (Pacira Pharmaceuticals), Exparel (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a product delivery technology. By using the DepoFoam platform, a single dose of Exparel delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours.
Pivotal studies have demonstrated the safety and efficacy of Exparel in patients undergoing bunionectomy or hemorrhoidectomy procedures, and additional studies are under way to further demonstrate the product’s safety and efficacy in other procedures.
Source: Pacira Pharmaceuticals; February 27, 2014.