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 pain, announced that it has completed patient enrollment in the two remaining Phase 3 studies of ARX-04 (sufentanil sublingual tablet, 30 mcg):
- 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). (Original Source)
Shares of Acelrx closed yesterday at $2.48, down $0.09 or -3.50%. ACRX has a 1-year high of $5.88 and a 1-year low of $2.42. The stock’s 50-day moving average is $3.17 and its 200-day moving average is $3.46.
On the ratings front, Acelrx has been the subject of a number of recent research reports. In a report issued on June 9, Jefferies Co. analyst Hugo Ong reiterated a Buy rating on ACRX, with a price target of $7, which implies an upside of 182.3% from current levels. Separately, on May 3, H.C. Wainwright’s Ed Arce reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Hugo Ong and Ed Arce have a total average return of -18.5% and 7.1% respectively. Ong has a success rate of 8% and is ranked #3588 out of 3967 analysts, while Arce has a success rate of 29% and is ranked #570.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company that focuses on the development and commercialization of therapies for the treatment of actual pain. Its lead product candidate includes ZalvisoTM intended for the management of moderate-to-severe acute pain in hospitalized adult patients. Zalviso consists of sufentanil sublingual tablets delivered by the Zalviso System, a needle-free, handheld, patient-administered, pain management system. It is designed to address the problems associated with post-operative intravenous patient-controlled analgesia, or IV PCA.