REDWOOD CITY, Calif., July 29, 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 Second Quarter financial results after market close on Monday, Aug 3rd, 2015. AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on Aug 3rd, 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 pain. AcelRx's lead product candidate, Zalviso™ (sufentail sublingual tablet system), is designed to improve 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. In the EU, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, has adopted a positive opinion for Zalviso. The positive opinion by the CHMP will next be reviewed by the European Commission for central marketing authorization in the European Union (EU), which has the authority to approve medicines for the 28 member countries of the EU which will also be valid in Norway, Iceland and Liechtenstein. If approved, Grunenthal expects to launch Zalviso beginning in the first half of 2016. In addition, AcelRx would be eligible to receive a $15 million milestone payment from Grunenthal upon approval. In the U.S. AcelRx has 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 (CRL) from the FDA. In March 2015, AcelRx received correspondence from the FDA stating that in addition to the bench testing and two Human Factors studies AcelRx has performed to address dispensing issues raised in the CRL, an additional clinical trial is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures. AcelRx has submitted a formal meeting request to the FDA and this request has been denied. AcelRx is evaluating its next steps with regards to the regulatory process for Zalviso in the U.S. In March 2015, AcelRx initiated SAP301, a pivotal Phase 3 study for ARX-04 (sufentanil sublingual tablets, 30 mcg), a product candidate for the treatment of moderate-to-severe acute pain in a medically supervised setting. SAP301 is now fully enrolled and AcelRx expects top-line data from this study in the fourth quarter of 2015. The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. 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, (CRL); statements related to the potential approval and timing of commercial launch of Zalviso in Europe; potential milestone payments under the Grunenthal agreement; AcelRx's plans to seek a pathway forward towards gaining approval of Zalviso in the U.S.; and the anticipated timing of the Phase 3 ARX-04, SAP301 trial's top line results; 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 in the EU and U.S.; any delays or inability to obtain and maintain regulatory approval of its product candidates, including Zalviso; its ability to obtain sufficient financing to receive regulatory approval for and commercialize Zalviso and complete clinical development of ARX-04; inability to successfully manufacture Zalviso to meet the requirements of Grunenthal and potential delays in the timing of the European launch; 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; AcelRx Pharmaceuticals' ability to finalize the pathway towards timely resubmission of the Zalviso NDA to the FDA; potential additional clinical trials, Human Factors studies, and/or additional data analyses necessary in order to resubmit the Zalviso NDA; the ability to maintain compliance with contractual compliance matters and requirements; 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-Q filed with the SEC on May 5, 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.
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SOURCE AcelRx Pharmaceuticals, Inc.
Timothy E. Morris, Chief Financial Officer, 650.216.3511, firstname.lastname@example.org; Brian Korb, The Trout Group LLC, 646.378.2923, email@example.com