REDWOOD CITY, Calif.,
March 9, 2015 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a
specialty pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute pain, today provided an update on the timing and potential
content of the resubmission of the New Drug Application ("NDA") for
Zalviso.
AcelRx late last week received correspondence from the Food and
Drug Administration ("FDA") stating that in addition to the bench
testing and two Human Factors studies it has performed, an
additional clinical study is needed to assess the risk of
inadvertent dispensing and overall risk of dispensing
failures. AcelRx had previously obtained confirmation from
the FDA that the protocol designs for the bench testing evaluating
dispensing failures and the Human Factors studies evaluating
inadvertent dispensing were acceptable to the FDA.
AcelRx plans to meet with the FDA to discuss and clarify the
agency's belief that an additional clinical study is needed, and
the potential design and objectives of such a study. As a
result of this FDA communication and the need for clarity with FDA,
AcelRx will not be making the Zalviso NDA resubmission this
quarter. AcelRx will provide an update on the timing of the
resubmission of the Zalviso NDA after AcelRx obtains more
information from the FDA.
The Complete Response Letter received by AcelRx in July 2014 in response to the Zalviso NDA
contained requests for additional information on the Zalviso System
to ensure proper use of the device. The requests included
provision of data demonstrating a reduction in the incidence of
system errors, changes to the Instructions for Use for the device,
and additional data to support the shelf life of the product.
In the CRL, there were no requests to conduct additional human
clinical studies. The CRL specifically identified Human
Factors studies as appropriate to assess the changes to the
instructions for use for the device.
Conference Call
AcelRx will conduct a conference call and webcast today,
March 9, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this update,
its financial results and program updates. To listen to the
conference call, dial in approximately ten minutes before the
scheduled call to 1-866-361-2335 for domestic callers,
1-855-669-9657 for Canadian callers, or 1-412-902-4204 for
international callers. Those interested in listening to the
conference call live via the Internet may do so by visiting the
Investors section of the company's website at www.acelrx.com and
selecting the Webcast link for the Q4 2014 earnings conference
call. A webcast replay will be available on the AcelRx
website for 90 days following the call by visiting the Investors
section of the company's website at www.acelrx.com.
About Zalviso™
Zalviso is an investigational pre-programmed, non-invasive
system to allow hospital patients with moderate-to-severe acute
pain to self-dose with sublingual sufentanil tablets to manage
their pain. Zalviso consists of sufentanil tablets delivered
by the Zalviso System, a needle-free, handheld,
patient-administered, pain management system (together,
"Zalviso"). Zalviso is designed to help address certain
problems associated with post-operative intravenous
patient-controlled analgesia, by
offering:
- A high therapeutic index opioid: Zalviso uses sufentanil, an
opioid that has a high therapeutic index. The therapeutic index is
the ratio of the effective dose versus the lethal dose. In animal
studies, the therapeutic index for sufentanil was approximately 100
times larger than fentanyl and 300 times larger than morphine.
- A non-invasive route of delivery: Zalviso utilizes a sufentanil
tablet which allows for a sublingual (under the tongue) route of
delivery. Sufentanil is highly lipophilic which provides for rapid
absorption in the fatty cells (or mucosal tissue) found under the
tongue and for rapid transit across the blood-brain barrier to
reach the mu-opioid receptors in the brain. The sublingual delivery
used by Zalviso provides rapid onset of analgesia. The sublingual
delivery system also eliminates the risk of IV-related analgesic
gaps and IV complications, such as catheter-related infections. In
addition, because patients do not require direct connection to an
IV PCA infusion pump through IV tubing, Zalviso allows for ease of
patient mobility.
- A pre-programmed PCA solution: Zalviso allows patients to
self-dose sufentanil sublingual tablets via a pre-programmed,
secure system designed to eliminate the risk of programming
errors.
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, 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 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.
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 process
and timing of anticipated future development of AcelRx's product
candidates, including Zalviso and ARX-04; the Zalviso NDA
submission and the CRL; the correspondence received from the FDA
requesting a clinical trial to address risk of inadvertent
dispensing and overall risk of dispensing failures; the tasks we
have completed to address the issues raised in the CRL, and
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; the impact, if any, of the FDA's review of the
amendments to the Zalviso NDA that were not previously reviewed; ;
and the therapeutic and commercial potential of AcelRx
Pharmaceuticals' product candidates, including Zalviso and
ARX-04.
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 timely resubmit the
Zalviso NDA to the FDA; potential additional clinical trials
necessary in order to resubmit the Zalviso NDA; AcelRx's 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; its
ability to obtain sufficient financing to receive regulatory
approval for and commercialize Zalviso and complete 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; the accuracy of AcelRx's estimates regarding expenses,
capital requirements and needs for financing; 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 November 10, 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.