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Zalviso

Generic name: sufentanil
Treatment for: Pain

AcelRx Pharmaceuticals Provides Zalviso Regulatory Update

REDWOOD CITY, Calif., May 4, 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 provided a regulatory update on Zalviso and reported financial results for the three months ended March 31, 2015.

Zalviso Regulatory Update

On April 21, 2015, AcelRx submitted a request to the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP or the Division) of the Food and Drug Administration (FDA) for a Type B meeting. This past Friday the Division notified the Company that the request for a meeting was denied and restated the Division's view that a clinical study is required. We are consulting with our regulatory, legal and clinical advisors to determine our next steps. We will be considering all options to determine a pathway forward for Zalviso including the possibility of dispute resolution through one of the FDA prescribed pathways as well as conducting additional clinical or Human Factors studies.

"As part of the Type B meeting, we intended to share with the Division the results of the bench testing and the Human Factors studies they had requested as part of the CRL and Type A meeting, and further discuss their desire for additional clinical work. We continue to believe that an additional clinical study should not be required to demonstrate the safety and efficacy of the Zalviso System beyond what has already been established in the Phase 3 clinical studies, as well as the bench testing and Human Factors studies," stated Howie Rosen interim chief executive officer of AcelRx Pharmaceuticals. "We will provide a further update as to our next steps once we finalize our plan for moving forward towards gaining Zalviso approval in the U.S."

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 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, 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 submitted a formal meeting request to the FDA and this request has been denied. AcelRx is currently evaluating its next steps with regards to the U.S. regulatory process for Zalviso. In March 2015, AcelRx initiated SAP-301, a pivotal Phase 3 study 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.

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 Zalviso and ARX-04; AcelRx's plans to seek a pathway forward towards gaining approval of Zalviso in the U.S., including meeting with outside advisors for consultation, potential additional clinical studies, additional Human Factors studies, additional data analyses, or the dispute resolution processes provided for by the FDA; AcelRx's belief that an additional clinical study should not be required to demonstrate the safety and efficacy of the Zalviso System beyond what has already been established in the Phase 3 clinical studies; anticipated resubmission of the Zalviso NDA to the FDA, including the scope of the resubmission and the timing of the resubmission and FDA review time; and the therapeutic and commercial potential of AcelRx Pharmaceuticals' product candidates, including Zalviso and ARX-04.

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 finalize the pathway towards timely resubmission of the Zalviso NDA to the FDA, including its ability to use dispute resolution processes provided for by the FDA; potential additional clinical trials, Human Factors studies, and/or additional data analyses necessary in order to resubmit the Zalviso NDA; AcelRx's ability to receive regulatory approval for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates, including Zalviso, in the United States and Europe; its ability to obtain sufficient financing to receive regulatory approval for and commercialize Zalviso and complete 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 or trials; the market potential for its product candidates; the accuracy of AcelRx's estimates regarding expenses, capital requirements and needs for financing, as well as the charges and savings attributable to the reduction in force; 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.

SOURCE AcelRx Pharmaceuticals, Inc.

Posted: May 2015

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