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AcelRx initiates Phase 3 study of pain treatment ARX-04
6 October 2015 • Author: Victoria White
AcelRx Pharmaceuticals has initiated 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.
ARX-04 is a non-invasive investigational product candidate consisting of 30 mcg sufentanil tablets delivered 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).
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.
ARX-04 shown to provide rapid onset of action in an earlier study
“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 US 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.”
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