AcelRx Pharmaceuticals Inc (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today provided a regulatory update on Zalviso™ (sufentanil sublingual tablet system) intended for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The company has received formal minutes of the telephonic meeting held in early September 2015, with the Division of Anesthesia, Analgesia, and Addiction Products of the Food and Drug Administration (FDA). As reflected in the minutes, the Division restated at the meeting a request for clinical data to complement other data AcelRx has developed to assess the overall performance of the Zalviso device.
The company is planning to submit a protocol to the Division for a clinical study in post-operative patients designed to evaluate the effectiveness of changes made to enhance product performance. AcelRx expects to be ready to initiate the study in the first quarter of 2016, and likely will await comments on the protocol from the Division. The company will be prepared to work with the FDA to facilitate the timely study initiation.
“We have been preparing a clinical study to investigate the use of Zalviso in a more diverse post-surgical population than in our original Phase 3 studies,” stated Pamela P. Palmer, MD, PhD, chief medical officer of AcelRx, “so we are modifying the design of this study to include endpoints that we believe will address the Division’s concerns.”
“The teleconference and meeting minutes were constructive, because they further clarified the Division’s position,” stated Howie Rosen, interim chief executive officer of AcelRx. “Even as ARX-04 advances through clinical development, Zalviso remains an important product for AcelRx, especially given its recent approval in Europe. We look forward to moving Zalviso toward resubmission, review and ultimate approval.” (Original Source)
Shares of Acelrx Pharmaceuticals closed yesterday at $3.67. ACRX has a 1-year high of $9.32 and a 1-year low of $2.92. The stock’s 50-day moving average is $3.86 and its 200-day moving average is $3.98.
On the ratings front, Acelrx has been the subject of a number of recent research reports. In a report issued on October 5, Roth Capital analyst Michael Higgins maintained a Buy rating on ACRX, with a price target of $10.50, which implies an upside of 186.1% from current levels. Separately, on September 14, H.C. Wainwright’s Ed Arce reiterated a Buy rating on the stock and has a price target of $8.50.
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 total average return of 8.6% and 19.4% respectively. Higgins has a success rate of 54.2% and is ranked #1035 out of 3772 analysts, while Arce has a success rate of 38.3% and is ranked #274.
AcelRx Pharmaceuticals Inc is a specialty pharmaceutical company. The Company is engaged in thedevelopment and commercialization of therapies for the treatment of acute pain.