REDWOOD CITY, Calif., April 30, 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 and breakthrough pain, today announced that it will release First Quarter financial results after market close on Monday, May 4th, 2015. AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on May 4th, 2015 to discuss the financial results and provide a corporate update.
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 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.
A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company's website at www.acelrx.com.
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 and breakthrough pain. AcelRx's lead product candidate, Zalviso, is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. AcelRx has announced positive results from each of the three completed Phase 3 clinical trials for Zalviso, and had submitted an NDA to the FDA seeking approval for Zalviso in the treatment of moderate-to-severe acute pain in adult patients in the hospital setting and on July 25, 2014, received a Complete Response Letter from the FDA. AcelRx received correspondence from the FDA stating that in addition to the bench testing and two Human Factors studies AcelRx has performed, an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures. AcelRx plans to meet with the FDA to discuss and understand the need and potential objectives of an additional clinical study for Zalviso. AcelRx has initiated a Phase 3 clinical trial for ARX-04, a product candidate for the treatment of moderate-to-severe acute pain in a medically supervised setting.
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
This press release contains forward-looking statements, including, but not limited to, statements related to the company's Zalviso NDA and the Complete Response Letter, or CRL, our anticipated resubmission of the Zalviso NDA to the FDA, the Phase 3 clinical trial for ARX-04, and the therapeutic and commercial potential of AcelRx Pharmaceuticals' product candidates, including Zalviso. These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' 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: AcelRx Pharmaceuticals' ability to receive regulatory approval for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates, including Zalviso; its ability to obtain sufficient financing to commercialize Zalviso and proceed with clinical development of ARX-04; the success, cost and timing of all product development activities and clinical trials, including the Phase 3 ARX-04 trial; the market potential for its product candidates; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' U.S. Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-K filed with the SEC on March 13, 2015. AcelRx Pharmaceuticals 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.