REDWOOD CITY, Calif.,
Aug. 15, 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, reported topline results from the single-arm, open-label
Phase 3 SAP302 trial (NCT02447848), which assessed ARX-04
(sufentanil sublingual tablet, 30 mcg) in patients who presented to
the emergency room with moderate-to-severe acute pain associated
with trauma or injury. Overall, the 76 adults treated with ARX-04
in this study experienced a mean pain intensity difference to
baseline (PID) of 2.9 from a baseline of 8.1, or 35%, on a 0 – 10
numeric rating scale at 60 minutes.
SAP302 enrolled patients in two cohorts. The initial phase
enrolled 40 adults who were administered a single dose of ARX-04;
and an extension phase enrolled 36 adults who were eligible to
receive up to four doses of ARX-04, given hourly as needed for
pain. Interim results from the first cohort were reported in
February 2016, and showed that
patients treated with a single dose of ARX-04 experienced a mean
pain intensity decrease from baseline of 2.7 at 60 minutes.
Patients in the second cohort reported a mean pain intensity
decrease from baseline of 3.1 on the 0 – 10 pain intensity
scale at 60 minutes. Of these 36 patients, seven received a second
dose of ARX-04, and two received a third dose. For 75% of patients
in the second cohort, a single dose of ARX‑04 was sufficient for
pain relief and only 8% of patients received morphine in addition
to ARX-04.
In addition, ARX-04 demonstrated a predicted onset of activity
in patients enrolled in SAP302. Patients reported a mean pain
intensity decrease of 1.1 compared to baseline 15 minutes following
first administration of ARX-04, and a decrease of 1.9 after 30
minutes.
Overall ARX-04 was well tolerated in this study, with 79% of
patients reporting no adverse events. The most common adverse
events reported in the study occurred with single-digit rates - the
most common being nausea (9%), somnolence (5%) and vomiting (4%).
All these events were rated as mild with the exception of one event
of moderate nausea. Drug-induced cognitive impairment was not seen
with ARX-04 in this study, as assessed using the validated Six-Item
Screener.
"The Department of Defense, which has provided us with
development funding for ARX-04, suggested that we conduct a
cognitive impairment assessment to determine if ARX-04 causes
cognitive deficiencies, which is an understandable concern when
treating wounded soldiers on the battlefield," explained Dr. Pamela
Palmer, co-founder and chief medical officer of AcelRx
Pharmaceuticals. "In addition to putting combat units in danger,
drug-induced cognitive effects can impede diagnosis and treatment
in a civilian emergency room. If borne out, ARX-04's onset of pain
relief, sublingual dosage form and side effect profile could make
it an attractive option for doctors considering opioid analgesic
treatment in emergency rooms and field-based settings."
About MHSRS
The above results are being presented
today at the 2016 Military Health System Research Symposium
(MHSRS), the Department of Defense's premier scientific meeting.
The MHSRS is being held at the Gaylord Palms Resort &
Convention Center in Kissimmee, FL
from August 15-18. It is a venue for
communicating and discussing new scientific knowledge resulting
from research and development aimed at optimizing care for members
of the Uniformed Services in operational settings. It is the only
military or civilian meeting that focuses specifically on the
unique medical needs of the warfighter.
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).
The ARX-04 Phase 3 clinical program is comprised of three
studies in patients with moderate-to-severe acute pain: SAP301, a
double-blind, placebo-controlled trial in ambulatory abdominal
surgery patients; SAP302, an open-label trial in adult emergency
room patients; and SAP303, an open-label trial in postoperative
patients. Results of SAP301, which were presented in 2015 at the
American Society of Anesthesiologists annual meeting, may be viewed
on the AcelRx website.
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
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 ARX-04
clinical trial results; anticipated submission of the New Drug
Application, or NDA, for ARX-04 to the U.S. Food and Drug
Administration, or FDA; AcelRx's pathway forward towards gaining
approval of Zalviso in the U.S.; the anticipated timing, design and
results of the IAP312 clinical trial for Zalviso; anticipated
resubmission of the Zalviso NDA to the FDA including the scope of
the resubmission and the timing of the resubmission, and FDA review
time; and the therapeutic and commercial potential of AcelRx's
product candidates, including potential market opportunities for
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 successfully
complete Phase 3 clinical development of ARX-04; 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 studies of ARX-04
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 July 29, 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.