AcelRx Pharmaceuticals Provides Clinical Trial Updates

            AcelRx Pharmaceuticals Provides Clinical Trial Updates

Continued progress towards NDA submission for Sufentanil NanoTab PCA System in
Q3 2013

PR Newswire

REDWOOD CITY, Calif., Feb. 19, 2013

REDWOOD CITY, Calif., Feb. 19, 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 continuing progress on its two
remaining Phase 3 trials of the Sufentanil NanoTab PCA System being studied in
post-operative pain. The first of those studies in patients after major
abdominal surgery completed the last patient earlier this quarter, and is
expected to provide data later this quarter. The second study, in patients
after major orthopedic surgery, continues to enroll patients, with the last
patient expected to enroll around the end of the first quarter of 2013, and
data expected in the second quarter. A New Drug Application (NDA) submission
for the NanoTab System remains on track for the third quarter of 2013. In
addition, a Phase 2 clinical trial with ARX-04, a sufentanil formulation for
the treatment of moderate-to-severe acute pain, has completed dosing and
results from this study are expected to be available in the second quarter of
2013.

"We look forward to sharing the top-line results from our abdominal surgery
pain study with our lead product candidate, the Sufentanil NanoTab PCA System,
later this quarter and remain on track for an NDA submission later this year,"
said Richard King, president and chief executive officer of AcelRx. 

Status of Ongoing Clinical Trials

  oThe last patient has completed the Sufentanil NanoTab PCA System Phase 3
    double-blind, placebo-controlled post-operative pain study conducted in
    patients following open abdominal surgery. The study, initiated in March
    2012, enrolled 178 patients at 14 sites. The study is designed to assess
    the ability of sufentanil, delivered through the NanoTab System to control
    moderate-to-severe post-operative pain over 48 to 72 hours compared to a
    placebo delivered through the NanoTab System. The study will also assess
    the tolerability, safety, and ease of use of the NanoTab System by nurses
    and patients. Top-line results are expected in the first quarter of
    2013.
  oA second placebo-controlled Phase 3 trial with the Sufentanil NanoTab PCA
    System is being conducted at approximately 32 sites in patients following
    hip or knee replacement surgery. Targeting enrollment of approximately
    400 patients, dosing of the final subject in this study is expected around
    the end of the first quarter of 2013. The primary endpoint for both the
    abdominal and orthopedic placebo-controlled Phase 3 studies is the sum of
    pain intensity difference to baseline (SPID) over 48 hours.Top-line
    results should be available for the orthopedic study during the second
    quarter of 2013.
  oDosing of the last patient in a Phase 2, placebo-controlled, dose-finding
    study of the Company's ARX-04 sufentanil NanoTab product has completed.
    This study, which began in November 2012, enrolled 101 patients following
    bunionectomy surgery, randomized into one of three groups: 20 mcg
    sufentanil NanoTab, 30 mcg sufentanil NanoTab or placebo. Each dose was
    administered by healthcare personnel, as requested by the patient, up to a
    maximum of one dose every hour. The study is designed to evaluate the
    ability of sufentanil NanoTabs to manage moderate-to-severe acute pain
    over the first 12 hours following bunionectomy surgery. ARX-04 is a
    sublingual sufentanil product candidate designed to provide a
    non-invasive, fast-onset treatment of patients with moderate-to-sever
    acute pain, both on the battlefield and in civilian settings of trauma or
    injury. AcelRx is conducting the study at two sites with funding provided
    by a $5.6 million grant from the U.S. Army Medical Research and Materiel
    Command (USAMRMC). Top-line results from the trial are expected during
    the second quarter of 2013. 

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,
the Sufentanil NanoTab PCA System, which is currently in Phase 3 clinical
development, 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 two additional product candidates which have completed Phase 2 clinical
development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03
for mild sedation, anxiety reduction and pain relief for patients undergoing
painful procedures in a physician's office. AcelRx has completed enrollment
in a Phase 2 study for a fourth product candidate, ARX-04, a sufentanil
formulation for the treatment of moderate-to-severe acute pain, funded through
a grant from USAMRMC. 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
clinical development of AcelRx Pharmaceuticals product candidates, including
the release of ARX-01 clinical trial data, the release of ARX-04 clinical
trial data, the potential submission of an NDA for ARX-01 and the timing
hereof, the therapeutic and commercial potential of ARX-01 and the anticipated
timing and therapeutic and commercial potential of other AcelRx
Pharmaceuticals product candidates including 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: the ability of AcelRx Pharmaceuticals to successfully
complete the final clinical trial for ARX-01; the duration of time required to
assess clinical trial results once the dosing of patients is completed; the
success, cost and timing of all product development activities and clinical
trials; the uncertain clinical development process, including the risk that
clinical trials have an effective design; the final Phase 3 study enrolls a
sufficient number of patients, or be completed on schedule, if at all; any
delays or inability to obtain regulatory approval of its product candidates in
the United States and Europe; its ability to obtain and maintain regulatory
approvals of its product candidates; 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 Current
Report on Form 8-K filed with the SEC on December 7, 2012. 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.

Website: http://www.acelrx.com
Contact: Jim Welch, Chief Financial Officer, +1-650-216-3511,
jwelch@acelrx.com
 
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