AcelRx Pharmaceuticals Presents Positive Clinical Data for the Sufentanil NanoTab PCA System at ASRA Medical Meeting

  AcelRx Pharmaceuticals Presents Positive Clinical Data for the Sufentanil
                  NanoTab PCA System at ASRA Medical Meeting

- Additional Phase 3 analysis show significantly faster reduction in pain and
fewer patients with oxygen desaturation events for Sufentanil NanoTab PCA
System than IV PCA with morphine -

- Sufentanil NanoTab PCA System remains on track for a Q3 2013 NDA submission
-

PR Newswire

REDWOOD CITY, Calif., May 2, 2013

REDWOOD CITY, Calif., May 2, 2013 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc.
(Nasdaq: ACRX), ("AcelRx"), a specialty pharmaceutical company focused on the
development and commercialization of innovative therapies for the treatment of
acute and breakthrough pain, today reported additional clinical results for
its lead product candidate, the Sufentanil NanoTab PCA System for the
treatment of moderate-to-severe acute pain in the hospital setting. These
data are being presented in five posters at the American Society of Regional
Anesthesia and Pain Medicine (ASRA) spring meeting held May 2 to May 5, 2013
in Boston, MA. New analyses from the Phase 3 comparison trial of the NanoTab
System to intravenous patient-controlled analgesia (IV PCA) with morphine (see
press release dated November 15, 2012) demonstrate that sufentanil delivered
via the NanoTab System has a significantly greater pain intensity reduction in
the first four hours after starting treatment than IV PCA morphine (p<0.01).
In addition, there were fewer patients throughout the study that experienced
oxygen desaturation events below 95% in the Sufentanil NanoTab PCA System
group than in the IV PCA morphine group (p=0.028). Oxygen saturation is a
measure of a patient's respiratory function and can be affected negatively by
opioids. A decrease in oxygen saturation can be linked to the serious adverse
event of respiratory depression.

"Obtaining effective control over post-operative pain early on is critical not
only for patient satisfaction, but to avoid the deleterious effects of
under-treatment of pain, such as pulmonary complications and an increased
stress response" remarked Marc Huntoon, MD, Professor and Chief, Division of
Pain Medicine at Vanderbilt University in Nashville TN. "Providing rapid,
effective analgesia following major surgery while reducing oxygen desaturation
events is an important advance in treatment of post-operative pain," added Dr.
Huntoon.

Four additional posters presented at the meeting highlighted recently released
results from a placebo-controlled Phase 3 study conducted in abdominal surgery
patients, new pharmacokinetic data from a study evaluating different
oral-transmucosal routes of delivery of sufentanil NanoTabs, design features
for the NanoTab System, and new data from three Human Factors studies
describing ease of set-up and use of the NanoTab System for patients and
healthcare personnel.

"We have significant data to present at meetings during the next year based on
the ongoing analysis of our recent clinical trials," stated Dr. Mike Royal,
chief, clinical affairs for AcelRx. "The well-published high therapeutic
index for sufentanil and its short brain equilibration time is being
reinforced by the clinical data that we are collecting," added Dr. Royal.

"We are excited to present this additional data at the ASRA meeting regarding
our NanoTab System. We are particularly pleased by the rapid reduction in
pain intensity after treatment is started, and the reduced number of patients
experiencing oxygen desaturation events, an important safety measure, when
using the NanoTab System," stated Richard King, president and CEO of AcelRx.
"We remain on track to submit an NDA for the NanoTab System later this year."

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, 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 results from two Phase 3 clinical trials
for the NanoTab System, and a third Phase 3 study has completed enrollment,
with data expected in the second quarter of 2013. A New Drug Application
submission is planned for the third quarter of 2013. AcelRx recently 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 USAMRMC. 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 process and timing of anticipated future
clinical development of AcelRx Pharmaceuticals' product candidates, including
the release of the NanoTab System and ARX -04 top-line clinical trial data,
the release and anticipated timing of additional NanoTab System clinical trial
data, the potential submission of an NDA for NanoTab System and the timing
thereof, therapeutic and commercial potential of NanoTab System and the
anticipated timing and therapeutic and commercial potential of other AcelRx
Pharmaceuticals' 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 ability of AcelRx
Pharmaceuticals to successfully complete the clinical trials for the
sufentanil NanoTab System, that fact that subsequent analyses of the data may
lead to different (including less favorable) interpretations of the results
than the analyses conducted to date, or be subject to differing
interpretations by the regulatory agencies; 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, or be completed on schedule; 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 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; 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 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.

(Logo: http://photos.prnewswire.com/prnh/20130226/MM67303LOGO)

SOURCE AcelRx Pharmaceuticals, Inc.

Website: http://www.acelrx.com
Contact: Jim Welch, Chief Financial Officer, 650.216.3511, jwelch@acelrx.com
 
Press spacebar to pause and continue. Press esc to stop.