Pacira Pharmaceuticals, Inc. (PCRX) recently reported positive interim results from a phase II/III study of Exparel as a femoral nerve block for patients undergoing total knee arthroplasty (TKA).
In a two-part double-blind, placebo-controlled study, the first part evaluated the safety and efficacy of Exparel at three doses (67 mg, 133 mg or 266 mg). It aimed at finding the most effective of the three doses. Data revealed that the 266 mg dosage was the most effective. The interim data supports the initiation of the phase III portion of the study.
This phase III portion will be initiated shortly with 180 patients receiving either 266 mg of Exparel or placebo as a femoral nerve block (1:1). This study will measure pharmacokinetic, safety data and multiple efficacy endpoints.
Apart from this, Exparel is also being studied as an intercostal block in posterolateral thoracotomy patients. Pacira has completed enrolling patients for this phase III study. Pacira expects the results from this study to allow the submission of a Supplemental New Drug Application (sNDA) for Exparel in the above indication in early 2014.
Exparel is currently approved by the US Food and Drug Administration (FDA) for administration into the surgical site to produce postsurgical analgesia.
Other candidates in Pacira’s pipeline include DepoNSAID for infiltration and intraarticular indication and DepoMethotrexate for rheumatoid arthritis and oncology.
Pacira carries a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. (SNTS), Jazz Pharmaceuticals Public Limited Company (JAZZ) and Salix Pharmaceuticals Ltd. (SLXP) look well-positioned with a Zacks Rank #1 (Strong Buy).
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