REDWOOD CITY, Calif.,
Dec. 14, 2015 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies designed for the
treatment of acute pain, today reported on the outcome of the
ARX-04 (sufentanil sublingual tablet, 30 mcg) pre-NDA meeting held
recently with the U.S. Food and Drug Administration (FDA).
The Company intends to pursue an ARX-04 indication for
moderate-to-severe pain in a medically supervised setting. To
support this indication, based on feedback from the FDA, the
Company will expand the clinical program by approximately 165
patients to include individuals from specific populations and
settings. Enrollment in the ongoing SAP302 open-label study in the
emergency room will be increased, 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 pain. SAP303 will
focus on enrolling patients greater than 40 years of age and will
allow for administration of ARX-04 for up to 12 hours. With these
modifications, assuming successful completion of the studies,
AcelRx anticipates submitting the NDA for ARX-04 in the second half
of 2016
The FDA has also agreed to include, as supporting safety
information, data from 323 patients treated in the Zalviso™
(sufentanil sublingual tablet system) clinical studies who had
administered two 15 mcg tablets 20-to-25 minutes apart. AcelRx had
previously completed and analyzed pharmacokinetic and modeling
data, which demonstrated the equivalency of one 30 mcg sublingual
sufentanil to two 15 mcg sublingual sufentanil tablets taken
20-to-25 minutes apart.
"Our pre-NDA meeting with the FDA was productive and provided
specific guidance for meeting the FDA's requirements for submitting
a New Drug Application for ARX-04," stated Dr. Pamela Palmer, co-founder and chief medical
officer of AcelRx. "Enrollment in the postoperative study (SAP303)
is estimated to take three months, and is expected to yield results
to help support the NDA submission and review. In addition, we are
encouraged that the FDA has agreed to consider a portion of the
Zalviso safety database when reviewing the ARX-04 NDA."
About ARX-04
ARX-04 is a non-invasive investigational
product candidate consisting of 30 mcg sufentanil tablets delivered
as often as once an hour sublingually via a disposable, pre-filled,
single-dose applicator (SDA). AcelRx is developing ARX‑04 for the
management of moderate-to-severe acute pain in a variety of
medically supervised settings, including the emergency room,
outpatient or ambulatory surgery, non-surgical patients
experiencing pain in the hospital, and post-operative patients
following short-stay surgery, who do not require more long-term
patient-controlled analgesia (PCA). ARX-04 is funded in part by the
U.S. Army Medical Research and Materiel Command (USAMRMC).
Based on its market research, the Company estimates there are
more than 51 million injury-related emergency department visits
annually that on average receive two doses of opioids for
moderate-to-severe pain in the United
States.
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) designed for
the treatment of moderate-to-severe acute pain in a medically
supervised setting; and Zalviso™ designed 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, with a focus on
enrolling patients greater than 40 years of age, allowing for
administration of ARX-04 for up to 12 hours, in the first quarter
of 2016. 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 and
the Company is working with the FDA regarding the resubmission of
the Zalviso NDA and initiation of a clinical study to support
resubmission.
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
enrollment and completion of the SAP302 and SAP303 studies for
ARX-04; estimated timing for filing the ARX-04 NDA; 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 or for its SAP302 or SAP303 studies; its ability to complete
Phase 3 clinical development of ARX-04; use of previously generated
data for support of the ARX-04 NDA; the success, cost and timing of
all product development activities and clinical trials, including
the SAP302 and SAP303 ARX-04 trials; 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.