REDWOOD CITY, Calif.,
Jan. 31, 2012 /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, reported that the two remaining items
required by the FDA prior to the initiation of the Phase 3 clinical
program for ARX-01, specifically software verification and
validation of the ARX-01 system, are progressing. AcelRx
believes that dosing of the first patient in the first ARX-01 Phase
3 study should occur either late Q1 or early Q2 2012. The
ARX-01 Phase 3 program is comprised of three studies – a
placebo-controlled post-operative pain study following major
abdominal surgery, a placebo-controlled study in patients after
major orthopedic surgery and an active comparator study comparing
the Sufentanil NanoTab PCA System to intravenous morphine
patient-controlled analgesia in post-operative patients.
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 Sufentanil NanoTab PCA System, which is in preparation
for 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. A fourth product
candidate, ARX-04, is a sufentanil product for the treatment of
moderate-to-severe acute pain that is expected to enter Phase 2
clinical development in the first quarter of 2012 under a grant
from the US Army Medical Research and Material Command, or
USAMRMC.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to the planned or
anticipated future clinical development of AcelRx Pharmaceuticals'
ARX-01 product candidate, including the expected initiation of its
Phase 3 studies for ARX-01, the timing thereof and events related
thereto, and the therapeutic and commercial potential of 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 success, cost and timing of AcelRx Pharmaceuticals' product
development activities and clinical trials; the uncertain clinical
development process, including the risk that the Phase 3 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; the uncertainty of the FDA's regulatory
process, including uncertainty as to whether AcelRx Pharmaceuticals
will be able to complete the software verification and software
validation activities required to initiate the first Phase 3
clinical study for ARX-01; its ability to obtain adequate clinical
supplies of the drug and device components of its product
candidates, including ARX-01; 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; 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 quarter ended September 30, 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.