REDWOOD CITY, Calif.,
May 31, 2011 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX)(AcelRx), today announced that
the US Army Medical Research and Material Command (USAMRMC) has
awarded AcelRx a $5.6 million grant
to support the development of a new product candidate, ARX-04, a
proprietary non-invasive, fast-onset sublingual product for the
treatment of moderate-to-severe acute pain. Commenting on the
award, Richard King, AcelRx
President and Chief Executive Officer stated, "ARX-04, a single
dose, higher strength iteration of our ARX-01 product, represents a
promising new application of our proprietary NanoTab® technology
for sublingual delivery of sufentanil, 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." Mr. King added, "USAMRMC has provided AcelRx with a
grant to support development of ARX-04 through completion of a
Phase 2 study, which we will begin in the second half of 2011."
Under the terms of the grant, the USAMRMC will reimburse
AcelRx for development, manufacturing and clinical costs necessary
to prepare for and complete the planned Phase 2 dose-finding trial
in a study of acute moderate-to-severe pain, and to prepare to
enter Phase 3 development.
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 (IV)
access available. Intramuscular injections are a 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 ARX-04
ARX-04 is a non-invasive, acute pain product candidate that
features 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
and display a consistent pharmacokinetic profile due to a high
percentage of drug being absorbed sublingually instead of through
the gastrointestinal tract. In the Phase 2 study of ARX-04,
two different doses of sufentanil will be evaluated in patients
suffering from moderate-to-severe acute pain, with the goal of
determining an appropriate dose to take into Phase 3. In
addition to battlefield casualty treatment, if approved, we
anticipate that ARX-04 could be useful in a variety of medically
supervised settings, including 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.
About AcelRx Pharmaceuticals, Inc.
Based in Redwood City, CA,
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) 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 SufentanilNanoTab PCA System, which is entering 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 inherent potential for programming and delivery errors
associated with 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 providing mild sedation, anxiety reduction and pain
relief for patients undergoing painful procedures in a physician's
office. ARX-04 will soon enter Phase 2 clinical development
for the management of acute pain in a medically supervised
setting.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to the US Army
Medical Research and Material Command grant for research and
development of AcelRx Pharmaceuticals' ARX-04 product candidate,
potential market for the ARX-04 product candidate and its
applications, the AcelRx Pharmaceuticals' statements relating to
ARX-04 Phase 2 clinical trial, the funding and timing of the
clinical trial and product candidate development. These
forward-looking statements are based on the company's 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 Pharmaceutical's product
development activities and clinical trials; its ability to obtain
and maintain regulatory approval of its product candidates,
including any new product candidates; its ability to obtain funding
for its operations and new product development; its plans to
research, develop and commercialize its product candidates,
including new product candidates; its ability to attract funding
partners or collaborators with development, regulatory and
commercialization expertise; the accuracy of AcelRx
Pharmaceutical's estimates regarding expenses, capital requirements
and needs for financing; and other risks detailed in the "Risk
Factors" and elsewhere in AcelRx Pharmaceuticals' Securities and
Exchange Commission filings and reports, including its Annual
Report on Form 10-K for the year ended December 31, 2010, and its Form 10-Q for the
quarter ending March 31, 2011.
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.