Pacira Pharmaceuticals, Inc. (PCRX) recently announced disappointing data from its second pivotal phase III study on Exparel. The randomized, double-blind study evaluated the safety and efficacy of Exparel in intercostal nerve block for posterolateral thoracotomy.
The study did not meet its primary endpoint of reducing cumulative pain scores over a three day period. Detailed data from the study is expected in the coming few weeks.
This phase III portion of the study evaluated 180 patients receiving either 266 mg of Exparel or placebo as an intercostal nerve block. In some countries data revealed positive results favoring Exparel while others had a very high placebo response.
Apart from this, Exparel is also being studied as a femoral nerve block for patients undergoing total knee arthroplasty (:TKA). In May 2013, Pacira reported positive interim results from a phase II/III study of Exparel as a femoral nerve block for patients undergoing 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. Currently, the phase III portion of the study is ongoing.
Pacira expects to submit a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (:FDA) for Exparel in the nerve block indication based on data from both these studies in early 2014.
Exparel is currently approved for administration into the surgical site to produce postsurgical analgesia.
Pacira carries a Zacks Rank #2 (Buy). Currently, companies like Pharmacyclics, Inc. (PCYC), Questcor Pharmaceuticals Inc. (QCOR) and Anika Therapeutics Inc. (ANIK) look well-positioned with a Zacks Rank #1 (Strong Buy).
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