REDWOOD CITY, Calif.,
Jan. 10, 2016 /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
announced anticipated 2016 milestones for its product portfolio,
including ARX-04 (sufentanil sublingual tablet, 30 mcg) and
Zalviso™ (sufentanil sublingual tablet system, 15 mcg).
Specifically, AcelRx's corporate goals in the upcoming year are as
follows:
- ARX-04 ER and Postoperative Study Completion. AcelRx has
finalized the remaining clinical plans for ARX-04 for the treatment
of moderate-to-severe acute pain in a medically supervised setting,
following a recent pre-NDA meeting with the FDA. Enrollment in the
current open-label study (SAP302) in the emergency room (ER) will
be continued, and a new study, known as SAP303, is expected to be
initiated in the first quarter of 2016 in postoperative patients
with moderate-to-severe acute pain. SAP303 will focus on enrolling
patients older than 40 years of age and will allow for
administration of ARX-04 for up to 12 hours. Both studies are
expected to be completed in 2016.
- ARX-04 NDA Submission. AcelRx intends to pursue an
indication for ARX-04 of moderate-to-severe acute pain in a
medically supervised setting. Assuming successful completion of the
above studies, the company anticipates submitting the NDA for
ARX-04 in the second half of 2016.
- Zalviso Open-Label Phase 3 Study Initiation and
Completion. The company continues to advance the regulatory
process for Zalviso and has completed a protocol review with the
FDA. The Phase 3 study (IAP312) will primarily measure the rate of
device errors, including the failure to dispense medication as well
as the incidence of misplaced or dropped tablets. AcelRx expects to
initiate the study in the first quarter of 2016.
- Zalviso NDA Submission. Pending timely completion of the
IAP312 study, AcelRx expects to resubmit the NDA for Zalviso before
the end of 2016.
- Zalviso EU Commercial Launch. In September 2015 the European Commission approved
Zalviso for the management of acute moderate-to-severe
post-operative pain in adult patients. The marketing authorization
was granted for the 28 EU member states as well as for the European
Economic Area countries, Norway,
Iceland and Liechtenstein. Grunenthal Group, AcelRx's
licensee in Europe, will be
working with the member states of the EU and EEA to ensure that
Zalviso is made available to those patients who would benefit from
an effective and reliable solution for their acute
moderate-to-severe post-surgical pain. The companies expect the
product to be available to Western European patients in the first
half of 2016.
"Our interactions with the FDA have been productive and have
provided guidance for meeting the FDA's requirements for submitting
an NDA for ARX-04 and the resubmission of an NDA for Zalviso,"
stated Howie Rosen, interim CEO of
AcelRx. "With this clarification on the regulatory pathways, our
focus in 2016 will be on execution. Pending positive and timely
results from our clinical studies, we anticipate NDA submissions
this year for both of our lead products. We also are actively
manufacturing supplies to support the launch of Zalviso in
Europe by our partner Grunenthal.
Should we achieve the milestones that we have laid out for
ourselves, 2016 will be a pivotal year for AcelRx."
Members of AcelRx senior management will be participating in The
Trout Group Annual 1x1 Management Access Event in San Francisco, January
11 – 14, 2016.
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 for the treatment of
moderate-to-severe acute pain in a medically supervised setting;
and Zalviso™ 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. In addition,
AcelRx intends to initiate SAP303 in the first quarter of 2016,
with a focus on enrolling patients greater than 40 years of age,
allowing for administration of ARX-04 for up to 12 hours.
AcelRx' other late stage development product, Zalviso, delivers
15 mcg sufentanil sublingually through a non-invasive delivery
route via a pre-programmed, patient-controlled analgesia device. In
response to the New Drug Application (NDA) AcelRx submitted to the
U.S. Food and Drug Administration (FDA) seeking approval for
Zalviso, AcelRx received a Complete Response Letter (CRL) on
July 25, 2014. The FDA has requested
an additional clinical study (IAP312), which AcelRx is planning to
initiate in the first quarter of 2016, to support resubmission of
the 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; timing for initiation and
completion along with anticipated results of IAP312 for Zalviso;
anticipated results and timing of the completion of the SAP302 and
SAP303 studies for ARX-04; launch timing and commercial
availability for Zalviso in Europe; AcelRx's plans to seek a pathway
forward towards gaining approval of Zalviso in the United States; 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 successfully design and complete the additional clinical
study requested by the FDA to support resubmission of the Zalviso
NDA; 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
and SAP303 ARX-04 trials and the IAP312 Zalviso trial; ability to
manufacture commercial supply of Zalviso; 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 3, 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.