AcelRx Pharmaceuticals completes patient enrollment in remaining phase 3 studies of ARX-04

SAP302 is a single-arm, open-label study that enrolled 76 adult patients who presented in the emergency room with moderate-to-severe acute pain associated with trauma or injury. The primary endpoint is the time-weighted summed pain intensity difference (SPID) to baseline over the first hour, or SPID1.

SAP303 is a multicenter, open-label study that enrolled 139 patients 40 years and older who had moderate-to-severe acute pain following a surgical procedure with general anesthesia or spinal anesthesia (except those who received intrathecal opioids). The primary efficacy endpoint of this study is SPID over the 12-hour study period, or SPID12.

Data from both studies are currently being analyzed, and top-line results are expected to be available in the third quarter of 2016.

Dr. Pamela Palmer, AcelRx’s chief medical officer and co-founder, stated, "Pending positive results for SAP302 and SAP303, we believe we are on track to file a New Drug Application for ARX-04 with the U.S. Food and Drug Administration (FDA) by the end of this year."

Howie Rosen, AcelRx’s chief executive officer, added, "The completion of enrollment in these ARX-04 clinical studies represents a tremendous accomplishment for AcelRx. With $106 million in cash on hand (as of the end of 1Q), I believe we are in a good financial position to drive ARX-04 through the regulatory process."

Clinical and Rehabilitative Medicine Research Program (CRMRP)

ARX-04 is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration and rehabilitation of traumatic injuries.

In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).

About ARX-04

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).

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 acute pain in the United States.