AcelRx Pharmaceuticals Doses the First Patients in ARX-04 Phase 2 Clinical Study

  AcelRx Pharmaceuticals Doses the First Patients in ARX-04 Phase 2 Clinical

- Phase 2 placebo-controlled, dose-finding study funded by a grant from the
Department of Defense -

PR Newswire

REDWOOD CITY, Calif., Nov. 5, 2012

REDWOOD CITY, Calif., Nov. 5, 2012 /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 that it has dosed the first
subjects in a Phase 2, placebo-controlled, dose-finding study of its ARX-04
sufentanil NanoTab product candidate. This study will enroll approximately
100 patients following bunionectomy surgery, randomized into one of three
groups; 20 mcg sufentanil NanoTab, 30 mcg sufentanil NanoTab or placebo,
administered by healthcare personnel, as needed every hour. The study will
evaluate the ability of sufentanil NanoTabs to manage moderate-to-severe acute
pain over the first 12 hours following bunionectomy, and correlate the pain
response with sufentanil pharmacokinetics. AcelRx is conducting the study
with funding provided by a grant from the U.S. Army Medical Research and
Materiel Command, or USAMRMC.

"ARX-04, a single-dose applicator containing a single sufentanil NanoTab,
represents a promising new application of our proprietary NanoTab^® technology
for sublingual delivery of sufentanil by healthcare personnel, and has the
potential to safely provide rapid onset of analgesia for patients in acute
pain, both on the battlefield and in civilian settings of trauma or injury,"
stated Richard King, AcelRx's president and CEO. 

In May 2011, USAMRMC awarded AcelRx a $5.6 million grant to support the
development of ARX-04, a proprietary non-invasive, fast-onset sublingual
product candidate for the treatment of moderate-to-severe acute pain. In
accordance with the development plans of the grant, AcelRx filed the IND with
the FDA during October 2011 and on November 1, 2012 initiated the Phase 2
study following protocol approval by the USAMRMC.

About ARX-04

ARX-04 is a product candidate in development for the treatment of
moderate-to-severe acute pain, consisting of sufentanil, a high therapeutic
index opioid, in AcelRx's proprietary NanoTab technology that enables rapid
sublingual absorption when the NanoTab is placed under the tongue. As a
result, sufentanil NanoTabs can provide rapid onset of analgesia in a
non-invasive method of administration and display a consistent pharmacokinetic
profile due to a high percentage of drug being absorbed sublingually instead
of through the gastrointestinal tract. In this Phase 2 study of ARX-04, two
different doses, 20 mcg and 30 mcg of sufentanil will be evaluated in patients
experiencing moderate-to-severe acute pain, in order to determine an
appropriate dose to advance into Phase 3. We believe ARX-04 may ultimately be
proven beneficial in a variety of medically supervised settings, including use
in battlefield casualty treatment, by paramedics during patient transport, in
the emergency room, for non-surgical patients experiencing pain in the
hospital, or for post-operative patients, following either short-stay or
ambulatory surgery, who do not require more long-term patient-controlled
analgesia (PCA). According to the Centers for Disease Control and Prevention
(CDC) data, there are more than 45 million injury-related emergency department
visits and 43 million ambulatory surgery procedures annually in the United

About Acute Pain

In situations of trauma or injury, it is advantageous to have a rapid-acting,
non-invasive method of treating acute pain. In the battlefield, in the
emergency room and in ambulatory care environments, patients often do not have
immediate intravenous, or IV, access available. Intramuscular injections are
the current standard of care on the battlefield, but they are invasive,
painful, and present an increased risk of infection to both patient and health
care professional. In addition, in cases of severe trauma where the patient
is often in hypovolemic shock and muscles are not well perfused, pain
medication given by intramuscular injection may not readily reach the blood
stream to provide pain relief, rendering this route of delivery suboptimal.
Oral pills and liquids generally have slow and erratic onset of analgesia.
Even patients with IV access may have undesirable side effects with the
commonly used IV opioids morphine and hydromorphone, such as sedation or
oxygen desaturation. Moreover, IV dosing results in high peak plasma levels,
thereby limiting the opioid dose and requiring frequent redosing intervals to
titrate to satisfactory analgesia. Additional treatment options are needed
which can safely and rapidly treat acute pain, in both civilian and military

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
ARX-01 Sufentanil NanoTab PCA System, is currently in Phase 3 clinical
development and is designed to solve problems associated with post-operative
intravenous patient-controlled analgesia, including side effects of morphine,
invasive IV route of delivery and the inherent potential for programming and
delivery errors associated with the complexity of infusion pumps. AcelRx has
two additional product candidates that 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 initiated 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 the
USAMRMC.For additional information about AcelRx's clinical programs please

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 anticipated timing for clinical trials and therapeutic and commercial
potential of AcelRx Pharmaceuticals' product candidates, including the study
enrollment, safety and market potential of 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 success, cost and timing of AcelRx Pharmaceuticals'
product development activities and clinical trials, including the Phase 2
ARX-04 clinical trial; the uncertain clinical development process, including
the risk that planned clinical trials may not begin on time, have an effective
design, enroll a sufficient number of patients, or be initiated or 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 adequate clinical supplies of the drug and device components of its
product candidates; its ability to attract funding partners or collaborators
with development, regulatory and commercialization expertise; its ability to
obtain sufficient financing to complete development and registration of its
product candidates in the United States and Europe; its ability to obtain and
maintain regulatory approvals 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 for the three
months ended June 30, 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.

Contact: Jim Welch, Chief Financial Officer, +1-650-216-3511,
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