AcelRx Pharmaceuticals Provides Clinical Trial Updates
Continued progress towards NDA submission for Sufentanil NanoTab
PCA System in Q3 2013
REDWOOD CITY, Calif., Feb. 19, 2013 /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 continuing progress on its two remaining Phase 3 trials of the Sufentanil NanoTab PCA System being studied in post-operative pain. The first of those studies in patients after major abdominal surgery completed the last patient earlier this quarter, and is expected to provide data later this quarter. The second study, in patients after major orthopedic surgery, continues to enroll patients, with the last patient expected to enroll around the end of the first quarter of 2013, and data expected in the second quarter. A New Drug Application (NDA) submission for the NanoTab System remains on track for the third quarter of 2013. In addition, a Phase 2 clinical trial with ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, has completed dosing and results from this study are expected to be available in the second quarter of 2013.
"We look forward to sharing the top-line results from our abdominal surgery pain study with our lead product candidate, the Sufentanil NanoTab PCA System, later this quarter and remain on track for an NDA submission later this year," said Richard King, president and chief executive officer of AcelRx.
Status of Ongoing Clinical Trials
The last patient has completed the Sufentanil NanoTab PCA System
Phase 3 double-blind, placebo-controlled post-operative pain study
conducted in patients following open abdominal surgery. The study,
initiated in March 2012, enrolled 178 patients at 14 sites. The
study is designed to assess the ability of sufentanil, delivered
through the NanoTab System to control moderate-to-severe
post-operative pain over 48 to 72 hours compared to a placebo
delivered through the NanoTab System. The study will also assess
the tolerability, safety, and ease of use of the NanoTab System by
nurses and patients. Top-line results are expected in the first
quarter of 2013.
A second placebo-controlled Phase 3 trial with the Sufentanil
NanoTab PCA System is being conducted at approximately 32 sites in
patients following hip or knee replacement surgery. Targeting
enrollment of approximately 400 patients, dosing of the final
subject in this study is expected around the end of the first
quarter of 2013. The primary endpoint for both the abdominal and
orthopedic placebo-controlled Phase 3 studies is the sum of pain
intensity difference to baseline (SPID) over 48 hours. Top-line
results should be available for the orthopedic study during the
second quarter of 2013.
Dosing of the last patient in a Phase 2, placebo-controlled,
dose-finding study of the Company's ARX-04 sufentanil NanoTab
product has completed. This study, which began in November 2012,
enrolled 101 patients following bunionectomy surgery, randomized
into one of three groups: 20 mcg sufentanil NanoTab, 30 mcg
sufentanil NanoTab or placebo. Each dose was administered by
healthcare personnel, as requested by the patient, up to a maximum
of one dose every hour. The study is designed to evaluate the
ability of sufentanil NanoTabs to manage moderate-to-severe acute
pain over the first 12 hours following bunionectomy surgery. ARX-04
is a sublingual sufentanil product candidate designed to provide a
non-invasive, fast-onset treatment of patients with
moderate-to-sever acute pain, both on the battlefield and in
civilian settings of trauma or injury. AcelRx is conducting the
study at two sites with funding provided by a $5.6 million grant
from the U.S. Army Medical Research and Materiel Command (USAMRMC).
Top-line results from the trial are expected during the second
quarter of 2013.
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,
which is currently in 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 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 mild sedation, anxiety
reduction and pain relief for patients undergoing painful
procedures in a physician's office. AcelRx has completed enrollment
in 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 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 release of ARX-01 clinical trial
data, the release of ARX-04 clinical trial data, the potential
submission of an NDA for ARX-01 and the timing hereof, the
therapeutic and commercial potential of ARX-01 and the anticipated
timing and therapeutic and commercial potential of other AcelRx
Pharmaceuticals product candidates including 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 ability of AcelRx Pharmaceuticals to successfully complete the
final clinical trial for ARX-01; the duration of time required to
assess clinical trial results once the dosing of patients is
completed; 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; the final Phase 3 study enrolls a sufficient number of
patients, or be 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 and maintain
regulatory approvals of its product candidates; 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 Current
Report on Form 8-K filed with the SEC on December 7, 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,
jwelch@acelrx.com
Web Site: http://www.acelrx.com
Posted: February 2013
