REDWOOD CITY, Calif.,
March 8, 2018 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a
specialty pharmaceutical company focused on innovative therapies
for use in medically supervised settings, today announced the
receipt of the official January 2018
Type A meeting minutes from the U.S. Food and Drug Administration
(FDA) relating to AcelRx's DSUVIA™ New Drug Application
(NDA).
At this meeting, AcelRx proposed potential resolutions for the
two main points identified in the Complete Response Letter (CRL)
received from the FDA in October 2017. These main points
were: (1) collect additional data in 50 patients with postoperative
pain sufficient to evaluate the safety of DSUVIA at the maximum
dosage in the proposed label, and (2) modify the Directions For Use
(DFU) to mitigate the risk of misplaced tablets and validate the
effectiveness of these changes in a human factors study. To
address the first point, AcelRx proposed instead to reduce the
maximum dose in the label to not exceed 12 tablets within a 24-hour
period to more closely match the clinical utilization of DSUVIA in
the trials. The Company proposed to the FDA that the existing
data from the higher dosing patients in the DSUVIA and Zalviso
clinical trials should be sufficient to evaluate the safety of
DSUVIA at this reduced maximum available daily dose. The FDA
stated that the proposed revision to the maximum daily dosage
appeared reasonable and that it was expected that the high-exposure
DSUVIA patient data combined with the high-exposure Zalviso patient
data may be sufficient to support safety at maximal dosing in the
DSUVIA NDA resubmission.
To address the second point in the CRL, AcelRx submitted to the
FDA an updated DFU, and a revised protocol for the human factors
(HF) study required to validate the effectiveness of the DFU
changes. The FDA has reviewed and recently provided its comments to
the updated DFU and HF study protocol, and the Company expects this
study to be completed next month. In the NDA resubmission,
AcelRx will provide these study results, along with the additional
DSUVIA and Zalviso data analysis supporting the reduced maximum
daily dosage. The Company intends to resubmit the NDA in the second
quarter of 2018 after the completion of the HF study.
"We are pleased with the constructive nature of the meeting with
the FDA, which has provided a clear path to resubmit the DSUVIA
NDA, which we expect to accomplish in the second quarter of this
year," said Vince Angotti, CEO of
AcelRx. "Completing the HF study next month is now the
priority to meet our resubmission timeline. We continue to
believe DSUVIA can satisfy a large unmet need within healthcare
settings, and we remain focused on our mission to provide
healthcare providers and patients with non-invasive pain management
options for moderate-to-severe acute pain within medically
supervised settings," continued Angotti.
Conference Call
As previously announced, AcelRx will conduct an
investment-community conference call today, March 8, 2018 at 4:30 p.m.
Eastern Time (1:30 p.m. Pacific
Time) to discuss its fourth quarter financial results at
which time it will also discuss the outcome of the Type A FDA
meeting. 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 a webcast of 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. The
webcast will be archived on the AcelRx website for 90 days
following the call.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company
focused on the development and commercialization of innovative
therapies for use in medically supervised settings. AcelRx's
proprietary, non-invasive sublingual formulation technology
delivers sufentanil with consistent pharmacokinetic profiles. The
Company has two product candidates including DSUVIA™
(sufentanil sublingual tablet, 30 mcg), known as DZUVEO outside
the United States, with a proposed
indication for the treatment of moderate-to-severe acute pain in
medically supervised settings, and Zalviso® (sufentanil
sublingual tablet system, SST system, 15 mcg) being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to the process
and timing of an NDA resubmission for DSUVIA with the FDA,
including the initiation and completion of the HF study as
recommended in the FDA's CRL. These forward-looking statements are
based on AcelRx's current expectations and involve significant
risks and uncertainties. AcelRx's actual results and timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, including, without limitation: risks related to the
ability to complete and achieve successful results from the
proposed HF study in connection with the resubmission of the DSUVIA
NDA to the FDA; the possibility that the FDA may dispute or
interpret differently the results of the Company's planned HF study
to validate the effectiveness of the changes in the DFU, or the
supplemental clinical information addressing the reduced maximum
dosage to be included in the planned resubmission of the NDA for
DSUVIA; any delays or inability to obtain and maintain regulatory
approval of DSUVIA in the United
States, DZUVEO in Europe
and ZALVISO in the United States;
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 November 9, 2017. 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.