Healthcare Industry News: Zalviso
News Release - January 21, 2016
AcelRx Pharmaceuticals Announces Presentation of Phase 3 Sufentanil Sublingual 30 mcg Tablet (ARX-04) Data at the European Congress of Ambulatory SurgeryPhase 3 Clinical Data Highlights Safety and Efficacy of Sublingual Sufentanil in Outpatient Abdominal Surgery Populations
REDWOOD CITY, Calif., Jan. 21, 2016 -- (Healthcare Sales & Marketing Network) -- AcelRx Pharmaceuticals, Inc. (ACRX) today announced that a presentation will be made at the annual European Congress of Ambulatory Surgery to be held January 28th and 29th, 2016 at the Disneyland Hotel New York Convention Centre in Paris, France. This bilingual congress (simultaneous translation will be provided) is co-organized by AFCA (French Association for Ambulatory Surgery) and the IAAS (International Association for Ambulatory Surgery) and will bring together over 800 ambulatory surgery stakeholders from Europe, Asia and North America.
The presentation marks the first time comprehensive results from the completed Phase 3 study (SAP301) using sublingual sufentanil 30 mcg tablets for the management of moderate-to-severe acute pain in outpatient abdominal surgery patients will be presented to the European academic and scientific community.
Details on the presentation time are as follows:
Session: FPS 3 - PARALLEL SESSIONS – Free AFCA-IAAS Papers
Room: ROOM 3
Date: 28 January 2016 from 14:00 to 14:45 (local time)
Title: Efficacy and Safety of Sublingual Sufentanil for the Management of Acute Pain Following Ambulatory Surgery
Authors: Harold Minkowitz, MD; Neil Singla, MD; David Leiman, MD; Timothy Melson, MD; Karen DiDonato, MSN, RN and Pamela P. Palmer, MD, PhD
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 pain. The company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg) designed for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso™ designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index opioid, sublingually through a disposable, pre-filled, single-dose applicator. AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and has advanced ARX-04 into a study (SAP302) in emergency room patients. In addition, AcelRx intends to initiate SAP303 in the first quarter of 2016, with a focus on enrolling patients greater than 40 years of age, allowing for administration of ARX-04 for up to 12 hours. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. In response to the New Drug Application (NDA) AcelRx submitted to the U.S. Food and Drug Administration (FDA) seeking approval for Zalviso, AcelRx received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an additional clinical study (IAP312), which AcelRx is planning to initiate in the first quarter of 2016, to support resubmission of the NDA.
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, including Zalviso and ARX-04; timing for initiation of IAP312 for Zalviso and SAP303 studies for ARX-04; AcelRx's plans to seek a pathway forward towards gaining approval of Zalviso in the United States; and anticipated resubmission of the Zalviso NDA to the FDA. These forward-looking statements are based on AcelRx's current expectations and inherently involve significant risks and uncertainties. AcelRx's 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, risks related to: any delays or inability to obtain and maintain regulatory approval of its product candidates, including Zalviso and ARX-04; its ability to successfully design and complete the additional clinical study requested by the FDA to support resubmission of the Zalviso NDA; its ability to timely resubmit the Zalviso NDA to the FDA and to receive regulatory approval for Zalviso; the fact that the FDA may dispute or interpret differently positive clinical results obtained to date from the pivotal Phase 3 ambulatory surgery study of ARX-04 (SAP301); its ability to complete Phase 3 clinical development of ARX-04; the success, cost and timing of all product development activities and clinical trials, including the SAP302 and SAP303 ARX-04 trials and the IAP312 Zalviso trial; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on November 3, 2015. AcelRx 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.
Source: AcelRx Pharmaceuticals
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