AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) announced that it has submitted a New Drug Application (NDA) under section 505(b)(2) with the U.S. Food and Drug Administration (FDA) for ARX-04 (sufentanil sublingual tablet, 30 mcg) for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting.
The NDA contains results of the entire ARX-04 clinical program, including data from four clinical trials in which ARX-04 was assessed as a treatment for moderate-to-severe acute pain in postoperative and emergency department patients. In each of these clinical studies, patients treated with ARX-04 demonstrated improvements in pain intensity as early as 15-to-30 minutes after the start of dosing. Adverse events reported in the studies were typical of opioid therapy, with the most common being nausea, headache, vomiting and dizziness.
“During my career before AcelRx, I saw first-hand the challenges of treating pain with IV opioids; and through our market research, it’s clear that my experiences were not isolated,” explained Dr. Pamela Palmer, co-founder and chief medical officer at AcelRx. “Even today, needs exist for non-invasive, cost-effective pain management in the emergency room, ambulatory surgical center, pre-hospital care, battlefield, and other diverse medical settings. We believe that ARX-04, with its sublingual delivery, could offer physicians and nurses a valuable treatment option in the treatment of moderate-to-severe acute pain.”
Howie Rosen, AcelRx’s chief executive officer, added, “The submission of the ARX-04 NDA is a significant corporate milestone for AcelRx. We are in the process of completing our commercialization plans so that we will be ready for an initial pilot launch in 2017, should ARX-04 be approved by the FDA. We also are using the NDA to prepare a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a target submission date in the first half of 2017 and are continuing to talk with potential European partners for ARX-04.” (Original Source)
Shares of AcelRX Pharmaceuticals closed yesterday at $2.95, down $0.30 or -9.23%. ACRX has a 1-year high of $4.67 and a 1-year low of $2.40. The stock’s 50-day moving average is $2.99 and its 200-day moving average is $3.21.
On the ratings front, AcelRX Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on December 6, Roth Capital analyst Michael Higgins reiterated a Buy rating on ACRX, with a price target of $15, which implies an upside of 408% from current levels. Separately, on December 5, H.C. Wainwright’s Ed Arce reiterated a Buy rating on the stock and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Higgins and Ed Arce have a yearly average loss of -15.8% and a return of 1.8% respectively. Higgins has a success rate of 33% and is ranked #4126 out of 4269 analysts, while Arce has a success rate of 31% and is ranked #1720.
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.