Not everyone is excited about AcelRx Pharmaceuticals (NASDAQ:ACRX), which focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. Despite the potential advantages, Oppenheimer analyst Leland Gershell believes the drug maker’s products may face challenges with market penetration given: (1) the broad effort to reduce opioids’ dominant role in analgesia, (2) the unclear advantage of needle-free delivery in populations who typically get IV access, and (3) the lack of physician familiarity with their active ingredient.
Gershell wrote, “Our tempered view of Dsuvia’s market opportunity is based on our research, which included discussions with physicians. Anesthesiologists and other specialists we have spoken with agree that Dsuvia could find some utility for acute pain management, and highlight the palliative care setting (e.g. home hospice) as well as military applications as settings in which Dsuvia would be attractive. However, they commented that IV line placement in the ER is essentially standard for patients presenting with more severe levels of pain, i.e., that would necessitate opioid treatment.”
But that’s not all. AcelRx’s acute pain drug Dsuvia has a November 3, 2018 FDA action date, in advance of which management expects the agency to hold an Advisory Committee meeting. Although Dsuvia’s registration package appears sufficient, recent regulatory actions against opioid products make it hard for Gershell to gauge the outcomes of these events. The analyst notes that approval has been challenging even for products which feature abuse resistance, as exemplified by last month’s 14-3 vote against approval of PTIE’s Remoxy (abuse-deterrent oxycodone extended-release) by an FDA Advisory Committee.
As such, Gershell initiates coverage on shares of AcelRx with a Perform rating. (To watch Gershell’s track record, click here)
Overall, TipRanks points to caution when it comes to AcelRx, with the Street divided on whether to be bullish, or sidelined on this biotech player. Out of 7 analysts polled in the last 12 months, 3 rate a Buy on ACRX stock, while 4 issue a Hold.