AcelRx Pharmaceuticals Announces Data Presentations for Zalviso™ at US and International Medical Meetings

REDWOOD CITY, Calif., Oct. 15, 2013 /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 presentations of its previously reported Phase 3 data for Zalviso™  (sufentanil sublingual microtablet system) at several major medical meetings in Europe and the United States.   Scheduled for presentation during the European Federation of IASP Chapters (EFIC) Annual Congress held in Florence, Italy on October 9-12, 2013 and at the American Society of Anesthesiologists (ASA) meeting in San Francisco being held on October 12-16, 2013, this is the first time data from the Phase 3 study of Zalviso in the treatment of post-operative pain in patients after knee or hip replacement surgery will be presented at a major medical meeting.  In addition, data from other Phase 3 Zalviso clinical studies will also be presented at these medical meetings.  Zalviso is a patient-activated, non-invasive analgesic system, which delivers 15 mcg sufentanil per dose sublingually as needed for pain control, subject to a 20-minute lockout period between doses.

"Presentations at important medical meetings in both the EU and US of favorable Phase 3 data for Zalviso represent an opportunity for investigators to discuss the trials and their impressions of Zalviso with other thought leaders in the pain-treatment community," stated Richard King, president and CEO of AcelRx.  "Presentations of this data are an important step in the familiarization of the medical community with Zalviso, and in enabling early understanding of the potential value the product may provide to their patients, if approved by the regulatory agencies."

The Phase 3 orthopedic study data presented at these meetings were from a trial that enrolled 426 patients to evaluate the ability of Zalviso to control pain during the 48-hours immediately following knee or hip replacement surgery, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline (SPID-48), compared to a placebo-treated group of patients.  Results demonstrated that patients receiving Zalviso realized a significantly greater SPID-48 during the study period than placebo-treated patients (+76.1 vs. -11.5, p<0.001).  Secondary endpoint data showed that SPID at 24 hours and 72 hours was also significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 in each case).  Adverse events reported in the study were generally mild or moderate in nature and were similar in both placebo and treatment groups for the majority of adverse events.

In addition to data from this Phase 3 orthopedic study, three other posters presented at both the EFIC meeting in Florence, Italy and the ASA in San Francisco highlight results from a Phase 3 placebo-controlled study conducted in abdominal surgery patients, a Phase 3 active-comparator  study comparing Zalviso to intravenous patient-controlled analgesia  (IV PCA) with morphine, and pharmacokinetic data from a study describing different routes of sufentanil delivery (IV vs. transmucosal vs. oral/swallowed), highlighting the clinical relevance of context-sensitive half-time (CST_½) and plasma:central nervous system equilibration half-life (t_½ke0) in selecting the appropriate opioid for treatment of acute pain.

Previously Reported Phase 3 Clinical Trial Results for Zalviso

At the end of September 2013, AcelRx submitted its NDA for Zalviso to the FDA for the management of moderate-to-severe acute pain in adult patients in the hospital setting.  The filing is based the data from AcelRx's three Phase 3 clinical trials. Zalviso met the FDA-agreed primary endpoint in the two double-blind, placebo-controlled Phase 3 registration studies conducted in patients who had undergone major open-abdominal surgery or orthopedic surgery that involved either knee or hip replacement procedures.  In each of these trials, patients treated with Zalviso to manage their post-surgical pain reported a rapid onset of pain relief.  In addition, patients treated with Zalviso reported a greater SPID-48 compared to placebo-treated patients (p=0.001 and p<0.001, respectively).  Adverse events reported across these two studies and considered possibly or probably related to treatment were generally mild-to-moderate in nature and similar for the majority of adverse events between Zalviso- and placebo-treated patients, with the exception of itching, which was significantly greater (p < 0.05) in the Zalviso-treated group.

The third Phase 3 study, an open-label, active-comparator trial comparing Zalviso to IV PCA with morphine demonstrated that Zalviso was non-inferior (p<0.001) and superior (p=0.007) to IV PCA morphine based on the primary endpoint of Patient Global Assessment of method of pain control comparison over the 48-hour trial period (PGA48) as determined by the combined percentage of patients with PGA ratings of "good" or "excellent".  Secondary endpoints of summed pain intensity, summed pain relief, and dropouts due to inadequate analgesia over the 48-hour study period were similar between treatment groups.  Zalviso-treated patients reported a significantly faster reduction in pain intensity compared to IV PCA morphine-treated patients in the first 4 hours of treatment.  Fewer patients experienced oxygen desaturation events below 95% in the Zalviso-treated group compared to the IV PCA morphine-treated patients (p=0.028).  In addition, both nurses and patients rated Zalviso significantly higher for Overall Satisfaction and Ease of Care compared to IV PCA with morphine.  Overall, adverse events in the comparison trial were similar and most were mild-to-moderate in nature in both treatment groups.

About Zalviso

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:

• 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.

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 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 www.acelrx.com.

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 and Europe; 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 and Europe; 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 August 12, 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.

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SOURCE AcelRx Pharmaceuticals, Inc.