REDWOOD CITY,
Calif., Dec. 2, 2013
/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 that
the Zalviso™ New Drug Application
(NDA) was accepted for filing by the FDA on November 26, 2013. The acceptance
for filing of the NDA indicates the FDA has determined that the
application is sufficiently complete to permit a substantive
review.
"We are extremely pleased with the filing of our NDA for
Zalviso, representing achievement of another critical milestone for
AcelRx," stated Richard King,
president and CEO of AcelRx. "Zalviso, if approved, will provide
hospitalized patients with a non-programmable, non-invasive,
patient-controlled treatment option for the management of
moderate-to-severe acute pain with a rapid onset of pain relief
compared to the commonly used, intravenous patient controlled
analgesia systems that typically utilize morphine."
The NDA, submitted on September 27,
2013, seeks approval for the marketing and sale of Zalviso
for the management of moderate-to-severe acute pain in adult
patients in the hospital setting. The NDA submission is based
primarily on data from a Phase 3 registration program that included
two double-blind randomized placebo-controlled clinical trials, one
conducted in patients following major abdominal surgery, the other
in patients following major joint replacement
surgery. Additionally, a Phase 3 open-label
active-comparator trial was conducted in patients following either
major abdominal or orthopedic surgery, comparing Zalviso to the
current standard of care, intravenous patient-controlled analgesia
(IV PCA) with morphine. Zalviso successfully
achieved the primary efficacy endpoints for each of these
studies. Treatment-emergent adverse events were
typical of opioid usage post-operatively, were generally
mild-to-moderate in nature, and were similar in both active- and
placebo-treatment groups for the majority of adverse
events.
About Zalviso
Zalviso is an investigational pre-programmed,
non-invasive, handheld system that allows hospital patients with
moderate-to-severe acute pain to self-dose with sublingual
sufentanil microtablets to manage their pain. Zalviso is
designed to address the limitations of IV PCA by
offering:
- A high therapeutic index opioid -
Zalviso uses the high therapeutic index opioid sufentanil.
It offers hospitalized adult patients with
moderate-to-severe acute pain 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 by Zalviso provides rapid
onset of analgesia, and also eliminates the risk of IV-related
analgesic gaps and IV complications, such as catheter-related
infections in IV PCA treated patients. In
addition, because Zalviso patients do not require direct connection
to an IV PCA infusion pump through IV tubing, Zalviso allows for
ease of patient mobility.
- A simple, pre-programmed PCA solution
– Zalviso is a pre-programmed PCA system designed to
eliminate the risk of infusion pump programming errors.
About Moderate-to-Severe Acute Pain
Moderate-to-severe acute pain management in the hospital
remains a challenge for healthcare providers with up to 75% of
patients reporting inadequate pain relief following surgery.
Inadequate treatment of moderate-to-severe pain can lead to
decreased mobility, which increases the risks for serious medical
complications, including deep vein thrombosis and partial lung
collapse, potentially resulting in extended hospital stays.
Approximately 12 million surgical procedures per year result
in moderate-to-severe pain in the U.S., with an additional 7.4
million hospital inpatients in the U.S. annually experiencing
moderate-to-severe acute pain from other, non-post surgical,
medical conditions. Currently, patients experiencing
moderate-to-severe acute pain in the hospital may have IV PCA
treatment, typically utilizing morphine or hydromorphone.
However, there are deficiencies associated with the current
use of IV PCA that can negatively impact patient safety, well-being
and recovery. These include drug-related side effects
associated with morphine or hydromorphone, complications associated
with IV delivery and medication delivery errors typically
associated with misprogramming of the complex IV PCA pumps.
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, Zalviso™, 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 complexity of infusion
pumps. 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 to be used to treat
moderate-to-severe acute pain in the hospital setting. AcelRx
has also announced positive top-line results for a Phase 2 trial
for ARX-04, a product candidate for the treatment of
moderate-to-severe acute pain in a medically supervised setting,
funded through a grant from the U.S. Army Medical Research and
Materiel Command. 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 anticipated receipt of the 74-day filing
letter from the FDA related to Zalviso submission, potential
approval of the NDA for Zalviso and the timing thereof,
the therapeutic and commercial potential of Zalviso and
the anticipated timing, and therapeutic and commercial potential of
other AcelRx product candidates. These
forward-looking statements are based on AcelRx's current
expectations and inherently involve significant risks and
uncertainties. AcelRx's 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's ability to receive regulatory approval for Zalviso, the
fact that FDA may dispute or interpret differently positive
clinical results obtained to date; any delays or inability to
obtain and maintain regulatory approval of its product candidates,
including Zalviso, in the United
States and Europe; its
ability to attract funding partners or collaborators with
development, regulatory and commercialization expertise; its
ability to obtain sufficient financing to commercialize Zalviso;
the market potential for its product candidates; the accuracy of
AcelRx's estimates regarding expenses, capital requirements and
needs for financing; and other risks detailed in the "Risk Factors"
and elsewhere in AcelRx's U.S. Securities and Exchange Commission
filings and reports, including its Quarterly Report on Form 10-Q
filed with the SEC on November 5,
2013. 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.