REDWOOD CITY, Calif.,
June 28, 2016 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of moderate-to-severe acute
pain, announced that it has completed patient enrollment in the two
remaining Phase 3 studies of ARX-04 (sufentanil sublingual tablet,
30 mcg):
- SAP302 is a single-arm, open-label study that enrolled 76 adult
patients who presented in the emergency room with
moderate-to-severe acute pain associated with trauma or injury. The
primary endpoint is the time-weighted summed pain intensity
difference (SPID) to baseline over the first hour, or SPID1.
- SAP303 is a multicenter, open-label study that enrolled 139
patients 40 years and older who had moderate-to-severe acute pain
following a surgical procedure with general anesthesia or spinal
anesthesia (except those who received intrathecal opioids). The
primary efficacy endpoint of this study is SPID over the 12-hour
study period, or SPID12.
Data from both studies are currently being analyzed, and
top-line results are expected to be available in the third quarter
of 2016.
Dr. Pamela Palmer, AcelRx's chief
medical officer and co-founder, stated, "Pending positive results
for SAP302 and SAP303, we believe we are on track to file a New
Drug Application for ARX-04 with the U.S. Food and Drug
Administration (FDA) by the end of this year."
Howie Rosen, AcelRx's chief
executive officer, added, "The completion of enrollment in these
ARX-04 clinical studies represents a tremendous accomplishment for
AcelRx. With $106 million in cash on
hand (as of the end of 1Q), I believe we are in a good financial
position to drive ARX-04 through the regulatory process."
Clinical and Rehabilitative Medicine Research Program
(CRMRP)
ARX-04 is funded in part by the Clinical and
Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army
Medical Research and Materiel Command (USAMRMC) under contract No.
W81XWH-15-C-0046. The CRMRP was established in 2008 to foster
research and technology advances for regeneration, restoration and
rehabilitation of traumatic injuries.
In accordance with USAMRMC guidelines, in the conduct of
clinical research, AcelRx has adhered to the policies regarding the
protection of human subjects as prescribed by Code of Federal
Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1,
Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human
Subjects).
About ARX-04
ARX-04 is a non-invasive investigational product candidate
consisting of 30 mcg sufentanil tablets delivered sublingually via
a disposable, pre-filled, single-dose applicator (SDA). AcelRx is
developing ARX‑04 for the management of moderate-to-severe acute
pain in a variety of medically supervised settings, including the
emergency room, outpatient or ambulatory surgery, non-surgical
patients experiencing pain in the hospital, and post-operative
patients following short-stay surgery, who do not require more
long-term patient-controlled analgesia (PCA).
Based on its market research, the Company estimates there are
more than 51 million injury-related emergency department visits
annually that on average receive two doses of opioids for
moderate-to-severe acute pain in the
United States.
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 pain. The Company's late-stage pipeline
includes ARX-04 (sufentanil sublingual tablet, 30 mcg) designed for
the treatment of moderate-to-severe acute pain in a medically
supervised setting; and Zalviso® (sufentanil sublingual
tablet system) designed for the management of moderate-to-severe
acute pain in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index
opioid, sublingually through a disposable, pre-filled, single-dose
applicator. AcelRx has reported positive results from the pivotal
Phase 3 SAP301 ambulatory surgery study, and has recently completed
enrollment of SAP302 (study in emergency room patients) and SAP303
(study in post-operative patients 40 years and older). Zalviso
delivers 15 mcg sufentanil sublingually through a non-invasive
delivery route via a pre-programmed, patient-controlled analgesia
device. In response to the New Drug Application (NDA) AcelRx
submitted to the U.S. Food and Drug Administration (FDA) seeking
approval for Zalviso, AcelRx received a Complete Response Letter
(CRL) on July 25, 2014. The FDA has
requested an additional clinical study (IAP312), which AcelRx is
planning to initiate once supply testing is complete in order to
support its NDA resubmission.
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 development of AcelRx's product candidates,
ARX-04 (sufentanil sublingual tablet, 30 mcg) and
Zalviso® (sufentanil sublingual
tablet system), including the planned initiation of the IAP312
clinical trial for Zalviso; anticipated resubmission of the Zalviso
NDA and submission of the ARX-04 NDA to the U.S. Food and Drug
Administration, or FDA; and the therapeutic and commercial
potential of AcelRx's product candidates, including ARX-04 and
Zalviso. These forward-looking statements are based on AcelRx
Pharmaceuticals' current expectations and inherently involve
significant risks and uncertainties. AcelRx Pharmaceuticals' actual
results and timing of events could differ materially from those
anticipated in such forward-looking statements, and as a result of
these risks and uncertainties, which include, without limitation,
risks related to AcelRx Pharmaceuticals' ability to complete Phase
3 clinical development of ARX-04 and support ARX-04 development
under the contract with the Department of Defense; AcelRx's ability
to successfully execute the pathway towards a resubmission of the
Zalviso NDA to the FDA, including the initiation and completion of
the IAP312 clinical study for Zalviso; any delays or inability to
obtain and maintain regulatory approval of its product candidates,
including ARX-04 in the United
States and Europe, and
Zalviso in the United States; the
uncertain clinical development process, including adverse events;
the risk that planned clinical trials may not begin on time, have
an effective clinical design, enroll a sufficient number of
patients, or be initiated or completed on schedule, if at all; the
success, cost and timing of all development activities and clinical
trials, including the Phase 3 ARX-04 SAP302 and SAP303 trials, and
the additional clinical trial for Zalviso, IAP312; the fact that
the FDA may dispute or interpret differently clinical results
obtained to date from the Phase 3 SAP301 study of ARX-04; the
market potential for AcelRx's product candidates; and other risks
detailed in the "Risk Factors" and elsewhere in AcelRx's U.S.
Securities and Exchange Commission filings and reports, including
its Annual Report on Form 10-Q filed with the SEC on May 2, 2016. AcelRx 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.
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SOURCE AcelRx Pharmaceuticals, Inc.