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AcelRx Pharmaceuticals Announces Presentation Of Phase 3 Data From ARX-04 Sufentanil Sublingual 30 mcg Program At The American Society Of Anesthesiology Meeting

TLPH | October 23, 2015

Presentation of Clinical Data from Recently Completed Phase 3 Study in Ambulatory Surgery Patients Highlights Efficacy and Tolerability of ARX-04 30 mcg

REDWOOD CITY, Calif., Oct. 23, 2015 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that a presentation will be made at the 2015 Annual Meeting of the American Society of Anesthesiologists (Anesthesiology 2015) to be held October 24^th to October 28^th at the San Diego Convention Center in San Diego, CA. For nearly 70 years, the ASA annual meeting has been the most comprehensive anesthesia educational event in the world, bringing together top influential and notable professionals in anesthesiology, pain medicine and critical care medicine. The ANESTHESIOLOGY^™ 2015 annual meeting is expected to welcome more than 13,000 healthcare professionals.

The presentation marks the first time top-line results from the phase 3 study using sublingual sufentanil 30 mcg tablets being studied for the management of moderate-to-severe acute pain in outpatient abdominal surgery patients, or SAP301, will be revealed to an academic and scientific community within the U.S.

"These positive results from SAP301 support the potential benefits of sublingual sufentanil for physicians and their patients," states Harold Minkowitz, MD, lead investigator in the study. "The onset of action, non-invasive route of administration and favorable tolerability could offer a new alternative for patients suffering from moderate-to-severe acute pain while transitioning off of IV analgesics, such as in outpatient surgery centers, or with limited IV access, such as in emergency rooms or field-based trauma settings."

Details on the presentation time are as follows:

Title: Safety and Efficacy of Sublingual Sufentanil 30mcg Tablets for the Treatment of Acute Pain Following Outpatient Abdominal Surgery

Presentation Date and Time: Monday, October 26, 2015, 4:45pm-5:15pm

Presentation Number: A3218 – Monitor 18

Location: San Diego Convention Center, Hall B2-Area E

Authors: Harold Minkowitz, MD; Shankar Lakshman, MD; Timothy Melson, MD; David Leiman, 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) for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso™ (sufentanil sublingual tablet system) 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. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU and is in late-stage development in the U.S. AcelRx submitted a New Drug Application (NDA) for Zalviso and received a Complete Response Letter (CRL) from the FDA on July 25, 2014. The FDA subsequently requested an additional clinical study to evaluate the effectiveness of product changes made in response to the CRL, 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 U.S.; 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 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 August 4, 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.