REDWOOD CITY, Calif.,
Aug. 1, 2012 /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 U.S. Patent
and Trademark Office (USPTO) has recently issued AcelRx Patent
Number 8,226,978 entitled "Small Volume Oral Transmucosal Dosage
Forms Containing Sufentanil for Treatment of Pain," and Patent
Number 8,231,900 entitled "Small-Volume Oral Transmucosal
Dosage Forms." The '978 patent claims a dosage form for oral
transmucosal administration of sufentanil and the '900 patent
claims a small-volume solid tablet containing a single dose of
sufentanil for oral mucosal administration to a subject.
These newly issued patents will provide intellectual property
protection for sufentanil NanoTab based products until at least
January 5, 2027. AcelRx
currently has more than 70 pending patent applications worldwide
and continues to file additional new patent applications to further
strengthen its market exclusivity.
"The addition of these two new patents further strengthens our
ability to protect our proprietary technology across our portfolio
of sufentanil NanoTab products, including our lead product, ARX-01,
the Sufentanil NanoTab PCA System," said Richard King, AcelRx's President and CEO.
"We will continue to pursue expansion of our patent portfolio
worldwide while also focusing on the execution of the ARX-01 Phase
3 clinical program, with data from two Phase 3 studies expected
later this year."
The 8,226,978 patent is the first composition of matter patent
the USPTO has issued in relation to sufentanil NanoTabs.
AcelRx exclusively owns this patent, which provides protection in
the United States for each of
AcelRx's four development programs. The '978 patent covers
AcelRx's proprietary NanoTab technology for delivering sufentanil
with claims to a bioadhesive dosage form for oral transmucosal
administration to a subject, comprising from about 5 to about 100
micrograms of sufentanil and a volume of less than 30 microliters
(or a mass of less than 30 milligrams), which generates a minimal
saliva response and delivers at least 55% of the sufentanil through
the transmucosal route resulting in consistent
pharmacokinetics.
The 8,231,900 patent also covers the composition of sufentanil
NanoTabs with claims to a single dose of sufentanil provided as a
substantially homogeneous, bioadhesive solid tablet for oral
transmucosal administration to a subject, comprising from about
0.25 micrograms to 200 micrograms of sufentanil, a volume of less
than 30 microliters, with complete erosion of the tablet evident
after about 5, 10 or 15 minutes.
AcelRx also holds U.S. Patent Number 8,202,535 entitled
"Small-Volume Oral Transmucosal Dosage Forms" which describes a
method of treating pain by administering a small-volume solid
tablet containing sufentanil by adhering to the oral mucosa.
The '535 patent will provide intellectual property protection for
sufentanil NanoTab based products in the
United States through late 2030. European patent protection
is provided by Patent Number EP2114383B1, which covers small-volume
NanoTab dosage forms for transmucosal administration containing the
opioid sufentanil. This European patent also covers elements of
AcelRx's dispensing technology and provides patent protection of
specific pharmacokinetic parameters derived from sublingual
administration using the NanoTab technology.
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, the ARX-01 Sufentanil
NanoTab PCA System, which is currently in Phase 3 clinical
development, 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 inherent potential for programming and delivery errors
associated with the complexity of infusion pumps. AcelRx has
two additional product candidates which have completed Phase 2
clinical development: ARX-02 for the treatment of cancer
breakthrough pain, and ARX-03 for mild sedation, anxiety reduction
and pain relief for patients undergoing painful procedures in a
physician's office. AcelRx plans to initiate a Phase 2
study, pending protocol approval, for a fourth product candidate,
ARX-04, a sufentanil formulation for the treatment of
moderate-to-severe acute pain, funded through a grant from
USAMRMC. 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 AcelRx
Pharmaceuticals' patent portfolio, including the useful life of its
U.S. patents and the European patent, the continued expansion of
its patent protection, market exclusivity, its ability to protect
its proprietary technology, the scope of patent protection, and
issued and planned or anticipated future clinical development of
AcelRx Pharmaceuticals' product candidates, including the execution
of the Phase 3 clinical studies for ARX-01, the timing of the
top-line data from two of the Phase 3 clinical trials, the
initiation of Phase 2 clinical trial for ARX-04, and the
therapeutic potential of AcelRx Pharmaceuticals' product
candidates. 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: the success, cost and timing of
AcelRx Pharmaceuticals' product development activities and clinical
trials; the success of its patent prosecution strategy; its ability
to protect its proprietary technology, including the risks that
pending patent applications may not result in issued patents; its
ability to obtain sufficient financing to complete development and
registration of its product candidates in the United States and Europe; its ability to obtain and maintain
regulatory approvals of its product candidates; the market
potential for its product candidates; and other risks detailed in
the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' U.S.
Securities and Exchange Commission filings, including its Quarterly
Report on Form 10-Q for the three months ended March 31, 2012. 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.
SOURCE AcelRx Pharmaceuticals, Inc.