REDWOOD CITY, Calif.,
Oct. 8, 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 pain, today provided a regulatory update on Zalviso™
(sufentanil sublingual tablet system) intended for the management
of moderate-to-severe acute pain in adult patients in the hospital
setting. The company has received formal minutes of the
telephonic meeting held in early September
2015, with the Division of Anesthesia, Analgesia, and
Addiction Products of the Food and Drug Administration (FDA).
As reflected in the minutes, the Division restated at the meeting a
request for clinical data to complement other data AcelRx has
developed to assess the overall performance of the Zalviso
device.
The company is planning to submit a protocol to the Division for
a clinical study in post-operative patients designed to evaluate
the effectiveness of changes made to enhance product performance.
AcelRx expects to be ready to initiate the study in the first
quarter of 2016, and likely will await comments on the protocol
from the Division. The company will be prepared to work with the
FDA to facilitate the timely study initiation.
"We have been preparing a clinical study to investigate the use
of Zalviso in a more diverse post-surgical population than in our
original Phase 3 studies," stated Pamela P.
Palmer, MD, PhD, chief medical officer of AcelRx, "so we are
modifying the design of this study to include endpoints that we
believe will address the Division's concerns."
"The teleconference and meeting minutes were constructive,
because they further clarified the Division's position," stated
Howie Rosen, interim chief executive
officer of AcelRx. "Even as ARX-04 advances through clinical
development, Zalviso remains an important product for AcelRx,
especially given its recent approval in Europe. We look forward to moving
Zalviso toward resubmission, review and ultimate approval."
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. The company's
late-stage pipeline includes ARX-04 (sufentanil sublingual tablet,
30 mcg) for the treatment of moderate-to-severe acute pain in a
medically supervised setting; and Zalviso™ (sufentanil sublingual
tablet system) for the management of moderate-to-severe acute pain
in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index
opioid, sublingually through a disposable, pre-filled, single-dose
applicator. AcelRx has reported positive results from the pivotal
Phase 3 SAP301 ambulatory surgery study, and has advanced
ARX-04 into a study (SAP302) in emergency room patients. Zalviso
delivers 15 mcg sufentanil sublingually through a non-invasive
delivery route via a pre-programmed, patient-controlled analgesia
device. AcelRx submitted a New Drug Application (NDA) for Zalviso
and received a Complete Response Letter (CRL) from the FDA on
July 25, 2014. The FDA subsequently
requested an additional clinical study to evaluate the
effectiveness of product changes made in response to the CRL, and
the Company is working with the FDA regarding the resubmission of
the Zalviso NDA.
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 process
and timing of anticipated future development of AcelRx's product
candidates, including the process and timing of anticipated future
development of Zalviso and ARX-04; anticipated results and timing
of the completion of the SAP302 study for ARX-04; AcelRx's plans to
seek a pathway forward towards gaining approval of Zalviso in the
U.S.; and anticipated resubmission of the Zalviso NDA to the FDA,
including the scope and timing of resubmission. These
forward-looking statements are based on AcelRx's current
expectations and inherently involve significant risks and
uncertainties. AcelRx's 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:
any delays or inability to obtain and maintain regulatory approval
of its product candidates, including Zalviso and ARX-04; its
ability to timely resubmit the Zalviso NDA to the FDA and to
receive regulatory approval for Zalviso; the fact that the FDA may
dispute or interpret differently positive clinical results obtained
to date from the pivotal Phase 3 SAP301 ambulatory surgery study of
ARX-04; its ability to complete Phase 3 clinical development of
ARX-04; the success, cost and timing of all product development
activities and clinical trials, including the SAP302 ARX-04 trial;
and other risks detailed in the "Risk Factors" and elsewhere in
AcelRx's U.S. Securities and Exchange Commission filings and
reports, including its Quarterly Report on Form 10-Q filed with the
SEC on August 4, 2015. AcelRx
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.