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:

http://protraderdaily.com/register/

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on PCRX. Go directly to your stock of interest and access today's free coverage at:

http://protraderdaily.com/optin/?symbol=PCRX

As per the Prescription Drug User Fee Act (PDUFA), the expected action date by the FDA is April 06, 2018.

About EXPAREL®

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.

Pro-Trader Daily:

Pro-Trader Daily (Pro-TD) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. PRO-TD has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles, and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

PRO-TD has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:

The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA® charter-holder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

NO WARRANTY

PRO-TD, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. PRO-TD, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, PRO-TD, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

NOT AN OFFERING

This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither PRO-TD nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://protraderdaily.com/disclaimer/.

CONTACT

For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:

Email: contact@protraderdaily.com

Phone number: (917) 341.4653

Office Address: Mainzer Landstrasse 50 Frankfurt am Main, Germany 60325

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Pro-Trader Daily

ReleaseID: 478359

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Featured Company News – Pacira Announces FDA Acceptance of sNDA for EXPAREL

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:

http://protraderdaily.com/register/

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on PCRX. Go directly to your stock of interest and access today's free coverage at:

http://protraderdaily.com/optin/?symbol=PCRX

As per the Prescription Drug User Fee Act (PDUFA), the expected action date by the FDA is April 06, 2018.

About EXPAREL®

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.

Pro-Trader Daily:

Pro-Trader Daily (Pro-TD) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. PRO-TD has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles, and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

PRO-TD has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:

The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA® charter-holder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

NO WARRANTY

PRO-TD, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. PRO-TD, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, PRO-TD, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

NOT AN OFFERING

This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither PRO-TD nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://protraderdaily.com/disclaimer/.

CONTACT

For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:

Email: contact@protraderdaily.com

Phone number: (917) 341.4653

Office Address: Mainzer Landstrasse 50 Frankfurt am Main, Germany 60325

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Pro-Trader Daily

ReleaseID: 478359

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:

http://protraderdaily.com/register/

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on PCRX. Go directly to your stock of interest and access today's free coverage at:

http://protraderdaily.com/optin/?symbol=PCRX

As per the Prescription Drug User Fee Act (PDUFA), the expected action date by the FDA is April 06, 2018.

About EXPAREL®

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.

Pro-Trader Daily:

Pro-Trader Daily (Pro-TD) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. PRO-TD has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles, and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

PRO-TD has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:

The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA® charter-holder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

NO WARRANTY

PRO-TD, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. PRO-TD, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, PRO-TD, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

NOT AN OFFERING

This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither PRO-TD nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://protraderdaily.com/disclaimer/.

CONTACT

For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:

Email: contact@protraderdaily.com

Phone number: (917) 341.4653

Office Address: Mainzer Landstrasse 50 Frankfurt am Main, Germany 60325

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Pro-Trader Daily

ReleaseID: 478359

Source URL: https://marketersmedia.com/featured-company-news-pacira-announces-fda-acceptance-of-snda-for-exparel/253065

Source: AccessWire

Release ID: 253065


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