REDWOOD CITY, Calif.,
Aug. 29, 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 8,252,328 entitled
"Bioadhesive Drug Formulations for Oral Transmucosal Delivery," and
Patent Number 8,252,329 also entitled "Bioadhesive Drug
Formulations for Oral Transmucosal Delivery." The '328 and '329
patents each make claims to a bioadhesive tablet for oral
transmucosal administration of sufentanil. 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.
"We have made significant progress this year in establishing our
intellectual property portfolio, with five issued US patents now
underpinning our novel NanoTab technology," said Richard King, AcelRx's President and CEO.
"We look forward to building on this success through emphasis
on the device aspects of our technology platforms as we seek
multiple avenues of protection for our proprietary pipeline of
product candidates."
The 8,252,328 patent is a composition of matter patent which
provides protection in the United
States for each of AcelRx's four development programs.
The '328 patent covers AcelRx's proprietary NanoTab
technology for delivering sufentanil with claims to a substantially
homogenous bioadhesive tablet, comprising from about 2.5 to about
100 micrograms of sufentanil and a volume of from about 3 to about
15 microliters, which adheres throughout the period of drug
delivery, generates a minimal saliva response and delivers a
majority of the drug through the oral mucosa.
The 8,252,329 patent also covers the composition of sufentanil
NanoTabs with claims to a bioadhesive tablet for sublingual
administration to a subject, comprising from about 2.5 micrograms
to about 100 micrograms of sufentanil, a volume of about 0.1
microliters to about 50 microliters, wherein the bioadhesive
material is present at between 2% and 30% by weight, and the tablet
generates a minimal saliva response and minimal swallowed drug and
delivers at least 55% of the sufentanil through the oral
transmucosal route. AcelRx exclusively owns both of these
patents.
AcelRx also holds three other U.S. patents which claim both
methods and compositions directed to sufentanil containing
NanoTabs. Collectively these patents 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 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 June 30, 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.