Zalviso is an investigational pre-programmed, non-invasive, handheld system that allows hospital patients with moderate-to-severe acute pain to self-dose with sublingual sufentanil microtablets to manage their pain. Zalviso is designed to address the limitations of IV PCA by offering:
About AcelRx Pharmaceuticals, Inc.
- A high therapeutic index opioid - Zalviso uses the high therapeutic index, highly lipophilic opioid sufentanil, enabling delivery via a non-intravenous route, and also supporting fast onset of effect.
- A non-invasive route of delivery - The sublingual route of delivery used by Zalviso eliminates the risk of IV-related analgesic gaps and IV complications, such as catheter-related infections in IV PCA treated patients. In addition, because Zalviso patients do not require direct connection to an IV PCA infusion pump through IV tubing, Zalviso allows for ease of patient mobility.
- A simple, pre-programmed PCA solution – Zalviso is a pre-programmed PCA system designed to eliminate the risk of infusion pump programming errors.
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 solve the problems associated with post-operative intravenous patient-controlled analgesia which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the complexity of infusion pumps. AcelRx has announced positive results from each of the three Phase 3 clinical trials for Zalviso and has submitted an NDA to the FDA seeking its approval. AcelRx has also announced positive top-line results for a Phase 2 trial for ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, funded through a grant from the U.S. Army Medical Research and Materiel Command. 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
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the Phase 3 clinical trial data for Zalviso, the therapeutic benefits of Zalviso, the process and timing of anticipated future clinical development of AcelRx Pharmaceuticals' product candidates, the commercial potential of Zalviso and the anticipated timing and therapeutic and commercial potential of AcelRx Pharmaceuticals' other product candidates. 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:
the fact that FDA may not accept for filing Zalviso NDA; ability to obtain regulatory approval for Zalviso, including whether the results of the Phase 3 clinical trials for Zalviso are sufficient to obtain marketing approval for Zalviso, which depends on the ability of AcelRx to demonstrate to the satisfaction of the FDA the safety and efficacy of Zalviso based upon its findings of the Phase 3 trials; any delays or inability to obtain and maintain regulatory approval of its product candidates in
the United States
; its ability to attract funding from partners or collaborators with development, regulatory and commercialization expertise; its ability to obtain sufficient financing to complete registration of its product candidates in
the United States
; the market potential for its product candidates; the accuracy of AcelRx Pharmaceuticals' estimates regarding expenses, capital requirements and needs for financing; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on
, 2013. 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.