Pacira Pharmaceuticals, Inc.
) 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:
). 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
Santarus, Inc. (
), Jazz Pharmaceuticals Public Limited Company
Salix Pharmaceuticals Ltd.
) look well-positioned with a Zacks Rank #1 (Strong Buy).
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