REDWOOD CITY, Calif.,
Nov. 10, 2014 /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 it has been granted International
Standards Organization (ISO) 13485:2003 certification of its
quality management system, an internationally recognized quality
standard for medical devices issued by the British Standards
Institution (BSI).
ISO 13485:2003 certification recognizes that consistent quality
policies and procedures are in place at AcelRx for the development,
design and manufacturing of medical devices. The certification
indicates that AcelRx has successfully implemented a quality system
that conforms to ISO 13485 standards for medical devices.
Certification to this standard is one of the key regulatory
requirements for a CE Mark in the European Union as well as
requirements in other international markets. The certification
applies to the Redwood City, CA
location which designs, manufactures and distributes finished
medical devices.
"The ISO certification is an important milestone for AcelRx as
we work together with Gruenenthal towards bringing Zalviso to the
European market," stated Richard
King, president and CEO of AcelRx. "The certification
confirms that our Quality System meets the highest
standards."
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 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 25th, received a Complete
Response Letter from the FDA. AcelRx plans to initiate a Phase 3
clinical trial for ARX-04, a product candidate for the treatment of
moderate-to-severe acute pain in a medically supervised setting, by
the end of 2014. 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 company's
Zalviso NDA and the Complete Response Letter ("CRL"), the recent
meeting held with the FDA to discuss the CRL, our plans to address
the issues raised in the CRL, our anticipated resubmission of the
Zalviso NDA to the FDA, including the scope of the resubmission and
the timing of the resubmission and FDA review time, planned
initiation of the Phase 3 clinical trial for ARX-04, and the
therapeutic and commercial potential of AcelRx Pharmaceuticals'
product candidates, including Zalviso. 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 receive regulatory approval for
Zalviso; any delays or inability to obtain and maintain regulatory
approval of its product candidates, including Zalviso, in
the United States and Europe; AcelRx's ability to build an effective
commercial organization; its ability to obtain sufficient financing
to commercialize Zalviso and proceed with clinical development of
ARX-04; the success, cost and timing of all product development
activities and clinical trials, including the planned Phase 3
ARX-04 trial; 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
and reports, including its Quarterly Report on Form 10-Q filed with
the SEC on August 11, 2014. 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.
Contacts:
Timothy E.
Morris
Chief Financial Officer
650.216.3511
tmorris@acelrx.com
Brian Korb
The Trout Group LLC
646.378.2923
bkorb@troutgroup.com
SOURCE AcelRx Pharmaceuticals, Inc.