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