News Release

AcelRx Pharmaceuticals to Hold a Conference Call and Webcast on Tuesday, August 1st to Discuss ZALVISO Phase 3 Top-line Data and Quarterly Financial Results

REDWOOD CITY, Calif., July 31, 2017 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, today announced that it will hold an investment-community conference call on Tuesday, August 1, 2017 at 8:30 am Eastern Time (5:30 am Pacific Time) to discuss top-line results from the IAP312 study. IAP312 was a Phase 3 study in which hospitalized, post-operative patients self-administered 15 microgram sufentanil sublingual tablets using ZALVISO® (sufentanil sublingual tablet system) as often as once every 20 minutes to manage their moderate-to-severe acute pain. The company also plans to discuss its financial results for the three and six months ended June 30, 2017.  

AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.)

Separate press releases regarding the Phase 3 IAP312 study top-line results and the company's financial results will be issued prior to the scheduled call. Please note, this conference call and webcast will replace the previously announced financial results conference call that had been scheduled for August 2, 2017.

Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to a webcast of the conference call live via the Internet may do so by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be archived on the AcelRx website for 90 days following the call.

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 moderate-to-severe acute pain. A New Drug Application (NDA) for DSUVIA (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was accepted for filing by the United States Food and Drug Administration (FDA) and has been given a PDUFA date of October 12, 2017. In the EU, the European Medicines Agency (EMA) has notified the company that the ARX-04 (sufentanil sublingual tablet, 30 mcg) Marketing Authorisation Application (MAA) has passed validation and that the scientific review of the MAA is underway.

The company's product candidate, ZALVISO® (sufentanil sublingual tablet system), is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The Phase 3 clinical trial, IAP312, was designed to evaluate the effectiveness of changes made to the functionality and usability of the ZALVISO device, to evaluate the incidence of inadvertent dosing, and to take into account comments from the FDA on the study protocol. 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 investigational and in late-stage development in the U.S. Grünenthal Group holds the rights for ZALVISO in Europe, where a commercialization across multiple countries is underway.

For additional information about AcelRx's clinical programs, please visit www.acelrx.com.

 

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SOURCE AcelRx Pharmaceuticals, Inc.

Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com