REDWOOD CITY, Calif.,
July 29, 2015 /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 will release
Second Quarter financial results after market close on Monday, Aug 3rd, 2015. AcelRx management will
host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on Aug 3rd, 2015 to discuss the financial results
and provide a corporate update.
Investors who wish to participate in the conference call may do
so by dialing (866) 361-2335 for domestic callers, (855) 669-9657
for Canadian callers or (412) 902-4204 for international callers.
Those interested in listening to the conference call live via the
internet may do so by visiting the Investors page of the company's
website at www.acelrx.com and clicking on the webcast link on the
Investors home page.
A webcast replay will be available on the AcelRx website for 90
days following the call by visiting the Investor page of the
company's website at www.acelrx.com.
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 pain. AcelRx's lead
product candidate, Zalviso™ (sufentail sublingual tablet system),
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. In the EU, the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency, has
adopted a positive opinion for Zalviso. The positive opinion by the
CHMP will next be reviewed by the European Commission for central
marketing authorization in the European Union (EU), which has the
authority to approve medicines for the 28 member countries of the
EU which will also be valid in Norway, Iceland and Liechtenstein. If approved, Grunenthal expects
to launch Zalviso beginning in the first half of 2016. In addition,
AcelRx would be eligible to receive a $15
million milestone payment from Grunenthal upon approval. In
the U.S. AcelRx 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 25, 2014, received a Complete Response
Letter (CRL) from the FDA. In March
2015, AcelRx received correspondence from the FDA stating
that in addition to the bench testing and two Human Factors studies
AcelRx has performed to address dispensing issues raised in the
CRL, an additional clinical trial is needed to assess the risk of
inadvertent dispensing and overall risk of dispensing failures.
AcelRx has submitted a formal meeting request to the FDA and this
request has been denied. AcelRx is evaluating its next steps with
regards to the regulatory process for Zalviso in the U.S. In
March 2015, AcelRx initiated SAP301,
a pivotal Phase 3 study for ARX-04 (sufentanil sublingual tablets,
30 mcg), a product candidate for the treatment of
moderate-to-severe acute pain in a medically supervised setting.
SAP301 is now fully enrolled and AcelRx expects top-line data from
this study in the fourth quarter of 2015. 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); statements
related to the potential approval and timing of commercial launch
of Zalviso in Europe; potential
milestone payments under the Grunenthal agreement; AcelRx's plans
to seek a pathway forward towards gaining approval of Zalviso in
the U.S.; and the anticipated timing of the Phase 3 ARX-04, SAP301
trial's top line results; 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 in the EU and U.S.; any delays or inability to
obtain and maintain regulatory approval of its product candidates,
including Zalviso; its ability to obtain sufficient financing to
receive regulatory approval for and commercialize Zalviso and
complete clinical development of ARX-04; inability to successfully
manufacture Zalviso to meet the requirements of Grunenthal and
potential delays in the timing of the European launch; the success,
cost and timing of all product development activities and clinical
trials, including the Phase 3 ARX-04 trial; the market potential
for its product candidates; AcelRx Pharmaceuticals' ability to
finalize the pathway towards timely resubmission of the Zalviso NDA
to the FDA; potential additional clinical trials, Human Factors
studies, and/or additional data analyses necessary in order to
resubmit the Zalviso NDA; the ability to maintain compliance with
contractual compliance matters and requirements; and other risks
detailed in the "Risk Factors" and elsewhere in AcelRx
Pharmaceuticals' U.S. Securities and Exchange Commission filings
and reports, including its Annual Report on Form 10-Q filed with
the SEC on May 5, 2015. 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.
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SOURCE AcelRx Pharmaceuticals, Inc.