AcelRx Pharmaceuticals Announces Sublingual Sufentanil Data Presentation at the American Society of Regional Anesthesia and Pain Medicine Meeting
Nov 19, 2015, 07:00 ET
REDWOOD CITY, Calif., Nov. 19, 2015 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, announced today that a moderated poster presentation will be made at the Emerging Technology session of the American Society of Regional Anesthesia and Pain Medicine (ASRA) 14th Annual Pain Medicine Meeting to be held November 19th to November 21st at the Fontainebleau Miami Beach in Miami, Florida. The annual ASRA meeting is the foremost scientific and educational event on invasive and non-invasive targeted therapies in pain medicine and brings together nearly 1,000 national and international thought leaders. Pamela Palmer, M.D. Ph.D., AcelRx Co-founder and Chief Medical Officer, will present safety and efficacy data from a Phase 3 trial, SAP301, evaluating the sufentanil sublingual 30 mcg tablet, or ARX-04, for the treatment of acute pain following ambulatory surgery.
Details on the presentation times are as follows:
Thursday, November 19, 2015 – Emerging Technology Moderated Poster Session, MP-02, Presentation time 10:45-12:45pm (local time), Splash 13
| Authors: |
Harold Minkowitz, MD, Shankar Lakshman, MD, Timothy Melson, MD, David Leiman, MD, Karen DiDonato, MSN, RN and Pamela Palmer, MD, PhD |
| Title: |
Safety and Efficacy Subgroup Analysis by Age of Sufentanil Sublingual 30 mcg Tablets for the Treatment of Acute Pain following Outpatient Abdominal Surgery |
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) for the proposed treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso™ (sufentanil sublingual tablet system) for the intended 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 (SAP-302) in emergency room patients. 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 and the Company is working with the FDA regarding the resubmission of the Zalviso NDA and initiation of a clinical study to support resubmission.
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 the process and timing of anticipated future development of Zalviso and ARX-04; anticipated results and timing of the completion of the SAP302 study 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, including the scope and timing of resubmission. 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 SAP301 ambulatory surgery study of ARX-04; 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 ARX-04 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.
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SOURCE AcelRx Pharmaceuticals, Inc.