REDWOOD CITY, Calif., Sept. 24, 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, today announced that the company will host an Analyst & Investor Day on Friday, October 2 in New York from 12:00pm – 2:00pm ET.
Members of the management team will discuss the AcelRx late-stage product candidates, Zalviso™ and ARX-04. A comprehensive update will also be provided on ARX-04, including recently reported and updated clinical results, anticipated market size and regulatory plans. Guest speakers scheduled to present at the event include:
- Dr. Harold Minkowitz, an anesthesiologist with the Hermann Memorial City Medical Center in Houston, TX; and
- Dr. James Miner, the chief of emergency medicine at Hennepin County Medical Center in Minneapolis, MN
An update will also be provided on Zalviso, which was recently approved for sale in the European Union.
The event will be webcast live and can be accessed through the Investors page at www.acelrx.com. For those not available to listen to the live broadcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.com.
For more information or to RSVP please contact Patrick Till at firstname.lastname@example.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. In the US, 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 sublingual, a high therapeutic index opioid, through a disposable, pre-filled, single-dose applicator (SDA). AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and will be advancing ARX-04 into a study in emergency room patients in 2015. Zalviso delivers 15 mcg sufentanil sublingual tablets 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, the Company received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an additional clinical study prior to the resubmission of the Zalviso NDA. Zalviso is authorized for marketing in the European Union as well as in the European Economic Union.
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 anticipated timing of the emergency room study for ARX-04. 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, the market potential for its product candidates, including Zalviso and ARX-04, in the United States and Europe; its ability to timely resubmit Zalviso NDA to the FDA and to receive regulatory approval for Zalviso, that fact that 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 planned Phase 3 ARX-04 emergency room 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.
SOURCE AcelRx Pharmaceuticals, Inc.