REDWOOD CITY, Calif.,
March 16, 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 reported dosing of the first patient in the
pivotal Phase 3 study of ARX-04. ARX-04 is a non-invasive,
single-use 30 mcg sufentanil sublingual tablet in a disposable,
pre-filled, single-dose applicator (SDA).
This study, SAP301, is a multi-center, double-blind,
placebo-controlled study that will evaluate the efficacy and safety
of ARX-04 vs. placebo for the treatment of moderate-to-severe acute
pain following ambulatory abdominal surgery. SAP301 is
expected to include approximately 160 adult patients, randomized
2:1 active to placebo, to be treated for up to 48
hours. ARX-04 or placebo will be administered by site staff as
requested by the patient, but no more than once per hour. The
primary endpoint of the study is to demonstrate a statistically
significant difference in the time-weighted summed pain intensity
difference (SPID) of ARX-04 compared to placebo over a 12-hour
dosing period (SPID-12). The study will be conducted at four
sites in the United States.
"We are pleased to have our pivotal ARX-04 Phase 3 clinical
trial underway. The ARX-04 product represents a promising new
application of our sublingual tablet technology for delivery of
sufentanil and has the potential to safely provide non-invasive,
fast-acting analgesia for patients in acute pain," stated Dr.
Pamela Palmer, AcelRx's founder and
Chief Medical Officer. "We anticipate enrollment to take up to
nine months. Pending the completion of enrollment in this
study, we anticipate top-line results in the fourth quarter of
2015."
About ARX-04
The ARX-04 SDA is a non-invasive,
single-use, disposable, handheld applicator that allows healthcare
professionals to effectively administer tablets to a patient's
sublingual space to manage their moderate-to-severe acute pain.
ARX-04 consists of a 30 mcg sufentanil sublingual tablet, in a
pre-filled SDA. AcelRx's proprietary tablet formulation enables
sublingual sufentanil absorption when ARX-04 is placed under the
tongue. As a result, ARX-04 can provide analgesia in a non-invasive
method of administration and display 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
the emergency room, or for post-operative patients, following
either short-stay or ambulatory surgery, who do not require more
long-term patient-controlled analgesia, as well as for battlefield
casualty treatment, and by paramedics during patient transport.
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
EU-5 there were more than 91 million adult emergency room visits
during 2011, of which it is estimated that more than 34 million
were associated with moderate-to-severe acute pain.
About Acute Pain
In situations of trauma or injury,
it is advantageous to have a rapid-acting, non-invasive method of
treating acute pain. In the emergency room and in ambulatory care
environments, or on the battlefield, patients often do not have
immediate intravenous, or IV, access available, or maintaining IV
access can be an impediment to rapid discharge. Oral pills and
liquids generally have slow and erratic onset of analgesia. IV
dosing results in high peak plasma levels, thereby limiting the
opioid dose and requiring frequent redosing intervals to titrate to
satisfactory analgesia. Additional treatment options are needed
that can safely and rapidly treat acute trauma pain, in both
civilian and military settings.
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. AcelRx's
lead product candidate, ZalvisoTM, is designed to
improve 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
announced positive results from each of the three completed Phase 3
clinical trials for Zalviso, and 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 from the FDA. In March
2015, the Company received correspondence from the FDA
stating that in addition to the bench testing and two Human Factors
studies it had performed in response to the issues identified in
the CRL, an additional clinical study is needed to assess the risk
of inadvertent dispensing and overall risk of dispensing failures.
The Company plans to meet with the FDA to discuss and clarify the
need for an additional clinical study, and the potential design and
objectives of such a study. 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 completion
of enrollment in SAP-301, the Company's first Phase 3 clinical
trial for ARX-04, the anticipated timing of top-line results from
SAP-301, regulatory approval of ZalvisoTM, 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 obtain sufficient financing to
proceed with clinical development of ARX-04; the success, cost and
timing of all product development activities and clinical trials,
including the Phase 3 clinical trials for ARX-04; the market
potential for its product candidates, including Zalviso and ARX-04;
the planned meeting with the FDA to discuss their request for an
additional clinical trial for Zalviso to address the risk of
inadvertent dispensing and overall risk of dispensing failures; and
other risks detailed in the "Risk Factors" and elsewhere in AcelRx
Pharmaceuticals' U.S. Securities and Exchange Commission filings
and reports, including its Annual Report on Form 10-K filed with
the SEC on March 13, 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.