Pacira Pharmaceuticals, Inc.
) recently announced positive data from a phase IV study,
EXCLAIM, evaluating the use of Exparel for postsurgical analgesia
in patients undergoing four common plastic surgery procedures,
namely, abdominoplasty, breast augmentation, breast reduction or
a combination of abdominoplasty/breast procedure. The study
revealed low pain scores, high satisfaction with pain control,
minimal opioid use and excellent overall benefit of analgesia
Under the EXCLAIM study (n=49), patients gave ratings to their
pain intensity; reported the number of opioids taken as rescue
medication and took note of any adverse effect associated with
the use of opioids.
Exparel is indicated for single-dose infiltration into the
surgical site to produce postsurgical analgesia. Exparel is the
first and only multivesicular liposome local anesthetic that can
be used in the same manner as local anesthetics in the peri- or
Exparel gained US Food and Drug Administration (FDA) approval
in Oct 2011 and was launched in Apr 2012. In the fourth quarter
of 2012, Exparel revenues were $7.8 million. Pacira has completed
a phase II study with Exparel in postsurgical analgesia - nerve
Two nerve block studies are currently being conducted
(intercostal block study in posterolateral thoracotomy patients
and a femoral nerve block in total knee arthroplasty (TKA)
patients) - these studies are scheduled to finish this year.
Positive results would allow the company to submit a Supplemental
New Drug Application (sNDA) in 2014.
Other candidates in Pacira's pipeline are DepoNSAID for
infiltration and intraarticular indication and DepoMethotrexate
for rheumatoid arthritis and oncology.
Pacira carries a Zacks Rank #4 (Sell). Currently, companies
Lannett Company, Inc.
) look more attractive in the pharmaspace with a Zacks Rank #1
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