Market Overview

AcelRx Pharmaceuticals Announces Initiation of Clinical Study with ARX-04 in Emergency Room Patients with Moderate-to-Severe Acute Pain


AcelRx Pharmaceuticals,
Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the
development and commercialization of innovative therapies for the treatment
of moderate-to-severe acute and breakthrough pain, today announced the
initiation of an open-label Phase 3 study (SAP302) of ARX-04 for the
treatment of adult patients who present in the emergency room with
moderate-to-severe acute pain associated with trauma or injury. The primary
efficacy endpoint is the summed pain intensity difference (SPID) over 1-hour
(SPID1). Safety endpoints, such as adverse events and vital signs will also
be assessed, as will the patients' and healthcare providers' satisfaction
with the method of pain control. The study is expected to be completed in
early 2016.
"In our recently concluded SAP301 study, ARX-04 was shown to provide a rapid
onset of action within 15 minutes of administration, making it well-suited
for use in an emergency room setting, where speed is critical and where
access to intravenous morphine may not be immediately available," stated Dr.
Pamela Palmer, co-founder and chief medical officer of AcelRx
Pharmaceuticals. "The SAP302 study is intended to provide us with valuable
insights into the optimal use of ARX-04 in the emergency room setting, one
of our initial target markets. It is also intended to complete the safety
database requirements previously agreed to with the FDA."
Howie Rosen, interim CEO of AcelRx, added, "As part of our development
program, we expect to meet with the U.S. Food and Drug Administration to
review plans for a New Drug Application for ARX-04 and will provide more
guidance on regulatory timing following that meeting."

Posted-In: News FDA Press Releases


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