REDWOOD CITY, Calif.,
Sept. 26, 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 provided an update on the plans
for the resubmission of the Company's New Drug Application (NDA)
for Zalviso™ (sufentanil sublingual tablet system). The
Company recently held a teleconference with representatives from
the Food and Drug Administration (FDA) to review the Company's
proposed response to the Zalviso Complete Response Letter (CRL)
received on July 25, 2014. The
Company had submitted a Briefing Document to the FDA ahead of the
teleconference and received preliminary comments from the FDA on
the Briefing Document. Based on the communications with the
FDA, subject to the timing of the FDA review and comment on
protocols to be submitted for the bench testing and Human Factors
Study, the Company is targeting resubmission of the Zalviso NDA in
the first quarter of 2015. However, depending on feedback from the
FDA, the timing of the filing of the NDA could be later than the
first quarter of 2015. The FDA also communicated that the
planned resubmission will qualify as a Class 2 resubmission with a
review period of six months.
During the teleconference with the FDA, the Company discussed
the items included in the CRL, specifically: testing of the
proposed mitigations to reduce the incidence of optical system
errors, changes to the Instructions for Use (IFU) for the Zalviso
System to address risk of inadvertent misplacement of tablets, and
submission of additional data to support the shelf life of the
product.
As a result of the communications, the Company confirmed that
bench testing would be an acceptable approach to evaluate the
reduction in optical system errors. The protocol for the
bench testing will be submitted to the FDA for review and
comment.
To address the risk of inadvertent misplacement of tablets, the
Company proposed mitigations through the Zalviso System and IFU and
to test these mitigations by way of a Human Factors Study.
The protocol for the Human Factors Study will be submitted to the
FDA for review and comment. The FDA stated that the adequacy of the
Human Factors Study and the results of the study will be subject to
final review and approval by the FDA.
Lastly, the Company proposed including additional stability data
in the resubmission to support the proposed 24 month shelf life of
the Zalviso System. The FDA has agreed with this approach subject
to review of the data previously submitted and to be submitted.
"The discussion with the FDA was productive," said Richard King, president and CEO of AcelRx.
"Over the coming months we will prepare, submit and finalize with
the FDA the protocols required to complete this work.
Assuming timely review by the FDA on the protocols, we anticipate
being able to complete the work with a target to refile the Zalviso
NDA in the first quarter of 2015. However, depending on
feedback from the FDA, the timing of the filing of the NDA could be
later than the first quarter of 2015."
The Company awaits receipt of the teleconference meeting minutes
from the FDA to confirm the target timelines discussed above.
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.
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SOURCE AcelRx Pharmaceuticals, Inc.