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 the initiation of the extension phase of the SAP302 study 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. This ongoing open-label Phase 3 study has completed the initial phase, enrolling 40 patients who each received a single dose of ARX-04. In this extension phase, up to an additional 100 patients may be enrolled, each of whom may receive multiple doses of ARX-04, given hourly as needed for pain, for up to 4 doses. The primary endpoint of SAP302 is the time-weighted summed pain intensity difference to baseline over one hour, or SPID-1.
Howie Rosen, interim chief executive officer of AcelRx, noted, “Our discussions with the U.S. Food and Drug Administration regarding the regulatory path for ARX-04 have been very productive. As part of our pre-NDA meeting, we agreed to expand enrollment in SAP302 in order to gain experience in patients who require multiple doses of ARX-04 in the emergency department. Pending completion of SAP303 and all other necessary activities, the initiation of this portion of the study keeps us on track for an anticipated submission of an NDA for ARX-04 for the treatment of moderate-to-severe acute pain in a medically supervised setting in the fourth quarter of 2016.”
Top-line interim results from the initial phase of SAP302, which were reported in February 2016, showed a clinically meaningful reduction in pain intensity with a single ARX-04 dose and an adverse event profile that was consistent with previous clinical studies. Nausea and somnolence were the most common adverse events and were each reported in two of the 40 patients. There have been no early terminations among participants due to adverse events.(Original Source)
Shares of Acelrx closed last Friday at $3.62, up $0.04 or 1.12%. ACRX has a 1-year high of $5.88 and a 1-year low of $2.59. The stock’s 50-day moving average is $3.64 and its 200-day moving average is $3.95.
On the ratings front, Acelrx has been the subject of a number of recent research reports. In a report issued on March 8, Cowen analyst Boris Peaker maintained a Hold rating on ACRX. Separately, on March 7, Roth Capital’s Michael Higgins maintained a Buy rating on the stock and has a price target of $10.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Michael Higgins have a total average return of 11.9% and -16.3% respectively. Peaker has a success rate of 43.3% and is ranked #233 out of 3724 analysts, while Higgins has a success rate of 23.5% and is ranked #3559.
AcelRx Pharmaceuticals Inc is a specialty pharmaceutical company. The Company is engaged in the development and commercialization of therapies for the treatment of acute pain.