Navigation Links
AcelRx Pharmaceuticals Confirms July 27, 2014 PDUFA Date for Zalviso

REDWOOD CITY, Calif., July 24, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today confirmed the PDUFA date for Zalviso remains July 27, 2014. 

The company recently learned that a rumor circulated online stating the Food and Drug Administration (FDA) had approved Zalviso.  As of July 24, 2014 there has been no notification to the company from the FDA regarding the status of the Zalviso New Drug Application (NDA). 

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain.  AcelRx's lead product candidate, ZALVISO, is designed to improve the management of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. AcelRx has announced positive results from each of the three completed Phase 3 clinical trials for ZALVISO, and has submitted an NDA to the FDA seeking approval for ZALVISO in the treatment of moderate-to-severe acute pain in adult patients in the hospital setting.  AcelRx plans to initiate a Phase 3 clinical trial for ARX-04, a product candidate for the treatment of moderate-to-severe acute pain in a medically supervised setting, during the second half of 2014. The company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development.  For additional information about AcelRx's clinical programs, please visit

Forward-Looking Statements
This press release contains forward-looking statements related to the anticipated approval of the Company's Zalviso NDA by the FDA. AcelRx Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, AcelRx Pharmaceuticals' ability to receive regulatory approval for Zalviso; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on May 8, 2014. AcelRx Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Logo -

SOURCE AcelRx Pharmaceuticals, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. AcelRx Pharmaceuticals Reports First Quarter 2012 Financial Results
2. AcelRx Pharmaceuticals Announces Pricing of a $10.0 Million PIPE Financing
3. AcelRx Pharmaceuticals, Inc. to Webcast, Live, at on July 12th
4. AcelRx Pharmaceuticals, Inc. Investor Presentation Now Available for On-demand Viewing at
5. AcelRx Pharmaceuticals Receives Two Additional U.S. Patents for Small-Volume Oral Transmucosal Dosage Forms
6. AcelRx Pharmaceuticals to Hold Second Quarter 2012 Financial Results Conference Call and Webcast on August 9, 2012
7. AcelRx Pharmaceuticals to Present at the Canaccord Genuity 32nd Annual Healthcare Conference
8. AcelRx Pharmaceuticals Reports Second Quarter 2012 Financial Results
9. AcelRx Pharmaceuticals to Present at Three Upcoming Investor Conferences
10. AcelRx Pharmaceuticals Receives Fourth and Fifth U.S. Patents for Small-Volume Oral Transmucosal Dosage Forms
11. AcelRx Pharmaceuticals to Present at the UBS Global Life Sciences Conference
Post Your Comments:
(Date:10/12/2015)... Oct. 12, 2015 A new computer program ... can predict whether they will develop effective language skills ... a study in the journal Brain and Behavior ... In the journal,s Oct. 12 online edition, researchers ... program determines how specific regions of the brain respond ...
(Date:10/12/2015)... Oct. 12 2015 ... of the "Personalized Medicine, Targeted Therapeutics ... Strategic Analysis of Industry Trends, Technologies, Participants, ... --> ) has announced ... Targeted Therapeutics and Companion Diagnostic Market to ...
(Date:10/12/2015)... , Oct. 12, 2015  Edwards Lifesciences Corporation (NYSE: ... valves and hemodynamic monitoring, plans to announce its operating results ... closes on Monday, October 26, 2015, and will host a ... those results. . A live stream and ... downloading Edwards, IR App for iPhone and iPad ...
Breaking Medicine Technology:
(Date:10/13/2015)... Miami, FL (PRWEB) , ... October 13, 2015 , ... ... announces the Driveway Snow Blanket, a snow melting invention that helps people in clearing ... $17 billion and will continue to grow at 3.8% per year," says Scott Cooper, ...
(Date:10/13/2015)... ... 2015 , ... With Fall weather approaching and holiday travel season upon us, ... Styler Contest. , Enter to win! , How to Enter:, 1. Like ... Style? , 3. Follow us on Instagram @thebeautyplace , 4. Share Facebook Contest ...
(Date:10/13/2015)... ... , ... Just under three months ago, eMarketing Concepts forever changed ... effectively offering all of their services for just a buck in the first month. ... phone calls from interested buyers. As a genuine one-stop-shop for internet marketing, EMC has ...
(Date:10/13/2015)... Virginia (PRWEB) , ... October ... ... International Biotechnology, LLC presented results from GyencoloGeneTM, the world’s first commercially-available next-generation ... the XXI FIGO World Congress of Gynecology and Obstetrics in Vancouver, BC, ...
(Date:10/12/2015)... (PRWEB) , ... October 13, 2015 , ... North American ... (IBC) at the 2015 IBC National Meeting in Rosemont, IL on October 4th. ... dedication, quality, and standards of excellence that customers have come to expect from members ...
Breaking Medicine News(10 mins):