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New Study Reveals Cost of Initial IV Opioid Dose in the Emergency Department for the Treatment of Acute Pain Exceeds $140

Results to be Presented at the 21st ISPOR Annual International Meeting

REDWOOD CITY, Calif., May 24, 2016 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today reported that the Company will be presenting an evaluation of the cost of delivering IV opioids in the emergency department for the treatment of acute pain. Based on an analysis of over 7 million patients who received IV opioids in 614 US emergency departments, it was found that the cost of administering an initial IV opioid dose ranges from $143 for morphine to $145 for fentanyl. This analysis will be presented at the 21st annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), which is being held May 21-25, 2016 in Washington, DC. The study was sponsored by AcelRx Pharmaceuticals, Inc.

"The cost of materials and labor, excluding the cost of the opioid, to establish an IV line to administer an opioid is almost 95% of the total cost, which is a substantial spend when you consider the number of patients visiting ERs annually," commented Dr. Pamela Palmer, AcelRx's chief medical officer and co-founder. "We believe that the development of a rapidly absorbed, non-invasive analgesic for emergency department use could be advantageous from both a cost and patient-benefit standpoint. We are developing ARX-04, our proprietary sufentanil sublingual 30 mcg tablet, for the treatment of moderate-to-severe acute pain designed to help address the time and cost of setting up an IV line as well as the other complications often associated with IV lines. We anticipate completing our clinical program and filing for regulatory approval later this year."

Details on the presentation time are as follows:

Date:        

Tuesday, May 24, 2016 from 3:45 – 7:45 pm (local time)



Title:         

Cost of Delivering Intravenous Opioid Analgesia in Emergency Departments in the United States



Authors: 

Pamela P. Palmer, MD, PhD, Brenda Lemus, MD and Karen DiDonato, MSN, RN of AcelRx Pharmaceuticals, Inc.; and John House, MS of Premier, Inc.

ISPOR meetings are designed to be forums for the discussion and dissemination of information related to health economics and outcomes research. The upcoming meeting in Washington, DC will specifically examine drug development, regulatory issues, and decision making through the lens of Value, Affordability, and Patient Centeredness. For more information on the conference, please visit www.ispor.org.

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® (sufentanil sublingual tablet system) 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 studies in emergency room patients (SAP302) and post-operative patients 40 years and older (SAP303). 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 once supplies are available, have been tested with acceptable results, and clinical sites are ready, in order to support its NDA 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, ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso® (sufentanil sublingual tablet system), including the planned initiation of the IAP312 clinical trial for Zalviso; anticipated resubmission of the Zalviso NDA to the U.S. Food and Drug Administration, or FDA; the timing of completion of ARX -04 clinical program and  submission of ARX-04 NDA to the FDA; and the therapeutic and commercial potential of AcelRx's product candidates, including ARX-04 and Zalviso. These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals' ability to complete Phase 3 clinical development of ARX-04 and support ARX-04 development under the contract with the Department of Defense; AcelRx's ability to successfully execute the pathway towards a resubmission of the Zalviso NDA to the FDA, including the initiation and completion of the IAP312 clinical study for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates, including ARX-04 in the United States and Europe, and Zalviso in the United States; the uncertain clinical development process, including adverse events; the risk that planned clinical trials may not begin on time, have an effective clinical design, enroll a sufficient number of patients, or be initiated or completed on schedule, if at all; the success, cost and timing of all development activities and clinical trials, including the Phase 3 ARX-04 SAP302 and SAP303 trials, and the additional clinical trial for Zalviso, IAP312; the fact that the FDA may dispute or interpret differently clinical results obtained to date from the Phase 3 SAP301 study of ARX-04; the market potential for AcelRx's product candidates; 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 May 2, 2016. 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.

Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com; Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com