LONDON, UK / ACCESSWIRE / October 20, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) ("Pacira"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=PCRX. The Company announced on October 18, 2017, that the US Food and Drug Administration (FDA) has accepted the resubmission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL® (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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As per the Prescription Drug User Fee Act (PDUFA), the expected action date by the FDA is April 06, 2018.
EXPAREL® is Pacira's flagship product. Presently, EXPAREL® is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. It combines bupivacaine with DepoFoam®, which is a unique and proprietary product delivery technology that encapsulates drugs without changing their molecular structure and releases them over a desired period of time. By leveraging the DepoFoam® platform, a single dose of EXPAREL® provides bupivacaine over time, providing considerable reductions in cumulative pain score. It leads up to 45% reduction in the opioid consumption although the clinical benefit of the opioid reduction was not yet demonstrated.
EXPAREL® was commercially launched in the US in April 2012. Currently, it is the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting.
About the Supplemental New Drug Application
The sNDA is basically centered on the positive data from a Phase-3 study of EXPAREL® in femoral nerve block for TKA (lower extremity), and a Phase-3 study of EXPAREL® in brachial plexus block for shoulder surgeries (upper extremity). Besides, it also comprises safety and pharmacokinetic data through 120 hours.
This extended indication of EXPAREL® has been substantiated by eight Pacira-sponsored studies. A total of 570 subjects were given a dose of EXPAREL® ranging from 2 mg to 310 mg. The sNDA also covers data from two investigator-initiated studies, which offer greater experience in smaller, peripheral nerve block settings.
Remarks from Pacira's CEO
Dave Stack, Chairman and Chief Executive Officer (CEO) at Pacira shared his views about this development. He believes that Pacira's sNDA filing contains all the important information needed to comply with the FDA requirements. This includes another clinical trial that validates the efficacy of EXPAREL® in a clinical setting beyond femoral nerve block, in addition to a comprehensive safety database, which includes pharmacokinetic profiles through the median time to maximum concentration of EXPAREL®.
Stack also stated that his team looks forward to working with the FDA for providing clinicians an extra option to provide postsurgical patients with long-lasting non-opioid pain control. This will help in reducing opioid requirements and also support the increasing clinical goal of transitioning inpatient procedures to an outpatient setting.
Last Close Stock Review
On Thursday, October 19, 2017, the stock closed the trading session at $33.10, marginally climbing 0.15% from its previous closing price of $33.05. A total volume of 472.09 thousand shares have exchanged hands. In the last twelve months, shares of the Company have advanced 0.91%. Since the start of the year, shares of Pacira Pharma have gained 2.48%. At Thursday's closing price, the stock's net capitalization stands at $1.33 billion.
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