REDWOOD CITY, Calif.,
May 14, 2015 /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 pain, today announced it has entered into Contract No.
W81XWH-15-C-0046 worth up to $17.0
million, supported by the United States Army Medical
Research and Materiel Command (USAMRMC) within the U.S. Department
of Defense (DoD). The contract provides partial funding for ongoing
development of ARX-04, including Phase 3 clinical, manufacturing
and regulatory activities. ARX-04 is in development as a
non-invasive, single-use 30 mcg sufentanil sublingual tablet in a
disposable, pre-filled, single-dose applicator (SDA), for the
anticipated treatment of moderate-to-severe acute pain in a
medically supervised setting.
"We recently announced the initiation of the pivotal Phase 3
study of ARX-04 and are now very pleased to announce the DoD's
continued support of ARX-04. The funding, together with our
existing resources, will allow us to complete the Phase 3
development program, continue with manufacturing activities, and
ready the product for the potential submission of a New Drug
Application (NDA). We are excited to continue our relationship with
the DoD, which began in 2011 through a $5.6
million grant to fund Phase 2 development. We believe ARX-04
can potentially provide great benefit to our servicemen and women
in the armed forces and presents promising commercial opportunities
in a wide range of medically-supervised settings such as emergency
rooms, and following short-stay surgeries," stated Howie Rosen, AcelRx interim Chief Executive
Officer.
Under the terms of the contract, commencing in Q2 2015, the DoD
will reimburse AcelRx for costs incurred for development,
manufacturing and clinical costs outlined in the contract,
including reimbursement for certain personnel and overhead
expenses. These development activities are intended to include
completion of the Phase 3 clinical program and manufacturing
development activities over the next 18-months.
About ARX-04
ARX-04 consists of a 30 mcg sufentanil sublingual tablet, in a
pre-filled single-dose applicator (SDA). ARX-04 is non-invasive,
single-use and disposable, allowing healthcare professionals to
administer a sufentanil tablet under a patient's tongue to manage
their moderate-to-severe acute pain. AcelRx's proprietary tablet
formulation enables sublingual sufentanil absorption when a tablet
is placed under the tongue, thereby providing analgesia with a
consistent pharmacokinetic profile, due to a high percentage of
drug being absorbed sublingually instead of through the
gastrointestinal tract. We believe ARX-04 may be a candidate
for use in a variety of medically supervised settings to manage
moderate-to-severe pain, including in emergency room patients;
post-operative patients who are transitioning from the operating
room to the recovery floor; patients who are recovering from either
short-stay or ambulatory surgery and do not require more long-term
patient-controlled analgesia; treatment of battlefield casualties;
and patients being transported by paramedics. According to the
National Emergency Department Sample, there were more than 104
million adult emergency room visits in the U.S. during 2011, of
which it is estimated that more than 48 million were associated
with moderate-to-severe acute pain; while in the five largest
markets in Europe there were more
than 91 million adult emergency room visits during 2011, of which
it is estimated more than 34 million were associated with
moderate-to-severe acute pain.
About USAMRMC
The USAMRMC is the Army's medical materiel developer, with
responsibility for medical research, development, and acquisition
and medical logistics management. The USAMRMC manages and executes
research in five basic areas: military infectious diseases, combat
casualty care, military operational medicine, chemical biological
defense, and clinical and rehabilitative medicine.
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 has initiated a Phase 3 clinical trial for ARX-04 and
is actively recruiting for that trial. In addition to ARX-04,
AcelRx's lead product candidate, Zalviso, is designed for the
management of moderate-to-severe acute pain in adult patients in
the hospital setting by utilizing a high therapeutic index opioid,
through a non-invasive delivery route via a pre-programmed,
patient-controlled analgesia device. AcelRx has submitted an NDA to
the FDA seeking approval for Zalviso in the treatment of
moderate-to-severe acute pain in adult patients in the hospital
setting and on July 25, 2014,
received a Complete Response Letter (CRL) from the FDA. In
March 2015, AcelRx received
correspondence from the FDA stating that in addition to the bench
testing and two Human Factors studies AcelRx has performed to
address dispensing issues raised in the CRL, an additional clinical
trial is needed to assess the risk of inadvertent dispensing and
overall risk of dispensing failures. AcelRx submitted a formal
meeting request to the FDA and this request has been denied. AcelRx
is currently evaluating its next steps to seek a pathway forward
towards gaining approval of Zalviso in the U.S., including
potential additional clinical studies, additional Human Factors
studies, or the dispute resolution processes provided for by the
FDA. The Company has two additional pain treatment product
candidates, ARX-02 and ARX-03, which have completed Phase 2
clinical development. 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, including Zalviso and ARX-04; statements related to the
completion of enrollment in ARX-04's Phase 3 trial and
anticipated timing of the trial's top line results; availability
and amount of funding to support ARX-04's development including
potential filing of an NDA; and the therapeutic and commercial
potential of AcelRx Pharmaceuticals' product candidates, including
Zalviso and 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: AcelRx Pharmaceuticals' ability to complete Phase 3
development for ARX-04, file an NDA and to receive regulatory
approval for ARX-04; the success, cost and timing of all product
development activities and clinical trials, including the Phase 3
ARX-04 trial; the market potential for its product candidates,
including Zalviso and ARX-04; the ability to maintain compliance
with contractual compliance matters and requirements; 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 filed with
the SEC on May 5, 2015. 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.
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SOURCE AcelRx Pharmaceuticals, Inc.