REDWOOD CITY, Calif.,
Aug. 23, 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 dosing of the first
patient in the third of three planned Phase 3 studies for ARX-01,
the Sufentanil NanoTab PCA System, its novel sublingual
patient-controlled analgesia (PCA) system. This third ARX-01
Phase 3 study is a randomized, double-blind, placebo controlled
efficacy and safety trial in adults following hip or knee
replacement surgery.
"The start of our third Phase 3 clinical trial for ARX-01 is an
important milestone for our lead Sufentanil NanoTab development
program," said Richard King,
AcelRx's president and CEO. "The results of all three Phase 3
registration studies are expected to form the basis of a New Drug
Application for ARX-01, which we plan to submit to the FDA during
the third quarter of 2013. The ARX-01 System is designed to
provide an attractive post-operative pain treatment alternative
compared to the current standard of care that utilizes intravenous
pumps primarily delivering morphine."
This third study is designed to enroll approximately 400
patients, randomized 3:1 to receive 15 mcg Sufentanil NanoTabs or
placebo NanoTabs. Both treatments are being delivered via the
ARX-01 system at a maximum dosing rate of one NanoTab every 20
minutes to control pain. Patients will be followed for a
minimum of 48 hours and, as needed, up to 72 hours after
randomization. The study will be conducted at approximately
45 academic and community hospitals in the U.S. The primary
endpoint is the sum of the pain intensity difference to baseline,
over the 48 hour study period, or SPID-48, which is the FDA
standard for post-operative acute pain studies. Secondary
endpoints include pain relief scores, patient global satisfaction
ratings, and use of rescue medication. The ease of set up and
operation of the ARX-01 system for nursing staff and patients,
respectively, will also be measured through questionnaires.
Topline results for the third Phase 3 clinical study are
expected to be available during the first quarter of 2013.
In March 2012, AcelRx began its
first Phase 3 clinical study for ARX-01, a randomized,
double-blind, placebo-controlled efficacy and safety study for
post-operative pain following major open abdominal surgery designed
to enroll 150 patients. The primary endpoint for this study
is SPID-48. In April 2012, the
second Phase 3 clinical study for ARX-01 began. It is a
randomized, multicenter, open-label, parallel group design that
compares the efficacy and safety of the Sufentanil NanoTab PCA
System to the standard of care, IV PCA with morphine, in the
treatment of post-operative pain associated with major abdominal or
orthopedic surgeries. The primary objective of the study,
which is expected to enroll approximately 400 patients, is to
compare ARX-01 to IV PCA with morphine in terms of patient global
satisfaction with the method of pain relief. Patients in each
of these two studies will be treated for a minimum of 48 hours
after randomization and topline results for both clinical trials
are expected during the fourth quarter of 2012.
About Post-Operative Pain
Acute pain management in the hospital, in particular
post-operative analgesia, remains a challenge for healthcare
providers with up to 75% of patients reporting inadequate pain
relief after surgery. Inadequate treatment of post-surgical
pain can lead to decreased mobility, which increases the risks for
medical complications, including deep vein thrombosis and partial
lung collapse, potentially resulting in extended hospital stays.
Over 23 million procedures per year result in moderate to
severe post-operative pain in the major pharmaceutical markets
(U.S., 5 main EU countries and Japan), resulting in $5.1 billion of acute pain treatment product
sales in 2008.
About ARX-01, the Sufentanil NanoTab PCA System
ARX-01 is a pre-programmed, non-invasive, handheld system that
allows post-operative patients to self-dose with sublingual
Sufentanil NanoTabs to manage their post-operative pain. The ARX-01
System is designed to address the limitations of the current
standard of care, IV PCA with morphine, by offering:
- A high therapeutic index opioid: Because ARX-01
uses the high therapeutic index opioid sufentanil, it offers
post-operative pain patients the potential for effective
patient-controlled analgesia with a low incidence of drug-related
side effects.
- A non-invasive route of delivery: The sublingual route
of delivery used in ARX-01 provides rapid onset of analgesia,
therefore eliminating the risk of IV-related analgesic gaps and IV
complications, such as catheter-related infections. In addition,
because patients are not tethered to IV tubing and a pump for pain
relief, ARX-01 allows for ease of patient mobility.
- A simple, pre-programmed PCA solution: ARX-01 is a
pre-programmed PCA System designed to eliminate the risk of pump
programming errors, which are a potential source of patient
harm.
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, 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 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 mild sedation, anxiety reduction
and pain relief for patients undergoing painful procedures in a
physician's office. AcelRx plans to initiate a Phase 2 study,
pending protocol approval, 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 planned or
anticipated future clinical development of AcelRx Pharmaceuticals'
product candidates, including the anticipated timing for clinical
trials, progress towards initiation of the Phase 2 study for
ARX-04, the timing of the top line data from all three Phase 3
clinical trials, the timing of submission of an NDA to the FDA 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 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; 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; 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.