REDWOOD CITY, Calif.,
May 10, 2011 /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 and breakthrough pain, announced that the opposition period
for a patent granted by the European Patent Office expired on
April 21 and to date there is no
indication that the patent has been opposed. The patent (European
patent EP2114383), covers small-volume NanoTab® dosage forms for
transmucosal administration containing the opioid sufentanil. This
patent covers elements of AcelRx's dispensing technology and also
provides patent protection of specific pharmacokinetic parameters
derived from sublingual administration using the NanoTab
technology. AcelRx has exclusive rights to the patent, which covers
key aspects of AcelRx's product candidates ARX-01, ARX-02 and
ARX-03. AcelRx registered the European patent in England, Germany, France, Spain, Italy,
Switzerland / Lichtenstein,
Denmark, Netherlands, Portugal, and Sweden.
AcelRx developed the NanoTab technology as a basis for
delivering sufentanil, a highly lipophilic, high therapeutic index
opioid, to control acute and breakthrough pain. The NanoTab
provides for rapid uptake of the drug via sublingual tissues,
enabling a rapid and consistent onset of effect.
"This patent is the first to issue from our broad portfolio of
pending intellectual property which provides long-term market
exclusivity for AcelRx NanoTab technology and pipeline product
candidates through at least 2027 in key markets" commented
Richard King, AcelRx President and
Chief Executive Officer. Mr. King added, "This patent is an
important component of AcelRx's formidable intellectual property
portfolio covering our sufentanil product candidates. We see
this patent issuance as a key milestone that underscores the
durable commercial potential of our market-focused acute and
breakthrough pain products."
About AcelRx Pharmaceuticals, Inc.
Based in Redwood City, CA,
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) 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 entering 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, which is designed to offer rapid onset of
analgesia, appropriate offset of pain relief and mitigation of
opioid abuse and misuse for the treatment of breakthrough pain
experienced by cancer patients, and ARX-03 for providing mild
sedation, anxiety reduction and pain relief for patients undergoing
painful procedures in a physician's office.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to AcelRx
Pharmaceuticals' intellectual property, breadth and commercial
potential of its patent portfolio, market for its products, its
clinical trials and product candidate development. These
forward-looking statements are based on the company's 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 Pharmaceutical's product
development activities and clinical trials; its ability to obtain
and maintain intellectual property protection for its product
candidates in the United States
and Europe; its ability to obtain
and maintain regulatory approval of its product candidates; its
plans to research, develop and commercialize its product
candidates; the market potential for its product candidates;
and other risks detailed in the "Risk Factors" and elsewhere
in AcelRx Pharmaceuticals' Securities and Exchange
Commission filings and reports, including its Annual Report on Form
10-K for the year ended December 31,
2010. 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.