REDWOOD CITY, Calif.,
July 25, 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 the U.S. Food and
Drug Administration (FDA) has issued a Complete Response Letter
(CRL) for the Company's new drug application (NDA) for Zalviso™
(sufentanil sublingual tablet system). The Company is
currently reviewing the FDA's comments and requests contained in
the CRL and plans to discuss these requests with the FDA.
The CRL contains requests for additional information on the
Zalviso System to ensure proper use of the device. The
requests include provision of bench data demonstrating a reduction
in the incidence of optical system errors which require premature
drug cartridge change, changes to the Instructions for Use for the
device, and additional data to support the shelf life of the
product. We believe some of the requests have been addressed
in amendments to the NDA that have been submitted prior to the
receipt of the CRL but, as acknowledged by the FDA, have not been
reviewed. There is no guarantee that the information
previously provided to the FDA will be adequate to address the
issues in the CRL. Additional bench testing will be required
and human factors testing may be required to address certain items
in the CRL. There were no requests to conduct additional human
clinical studies.
"We believe we can satisfy all of FDA's requests in the CRL and
resubmit the NDA by the end of 2014, although we will have more
clarity on the process and timing after our conversation with FDA,"
said Richard King, president and CEO
of AcelRx. "We are confident in the Zalviso development
program and will work closely with the FDA to address the Agency's
concerns as outlined in the CRL to ensure that healthcare
professionals and patient communities will have access to
Zalviso."
Conference Call
There will be a conference call and webcast with AcelRx
management on Monday, July 28, 2014
at 8:30 a.m. Eastern time
(5:30 a.m. Pacific time) to discuss
the Zalviso CRL. The conference call will be available via phone
and webcast. The dial in and webcast information is listed
below:
Toll-Free US & Canada: 877-407-3109
International: 201-493-6798
Replay Information:
Conference ID #: 13587613
Replay Dial-In (Toll Free US & Canada): 877-660-6853
Replay Dial-In (International): 201-612-7415
Expiration Date: 8/4/14
Webcast URL:
http://acelrx.equisolvewebcast.com/q2-2014
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"), 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 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 May 8, 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
Investor Enquiries
Brian
Korb
The Trout Group, LLC
bkorb@troutgroup.com
646-378-2923
Timothy E Morris
Chief Financial Officer
tmorris@acelrx.com
650-216-3511
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SOURCE AcelRx Pharmaceuticals, Inc.