(Reuters) – AcelRx Pharmaceuticals Inc’s shares plunged more than 60 percent before the bell on Thursday after the U.S. Food and Drug Administration rejected the drugmaker’s opioid painkiller in its present form.
The FDA’s decision comes at a time when the United States is battling an opioid abuse crisis, with federal authorities implementing a slew of measures to limit their supply, especially by requiring drugmakers to prove that their painkillers deter abuse.
Analysts were optimistic about the approval of AcelRx’s Dsuvia, considering its limited abuse potential as well as the regulator’s decision to not hold an advisory committee meeting.
The drug is intended to be used in medically supervised settings, such as emergency services and ambulatory surgical centers – limiting its abuse potential.
RBC Capital Markets analyst Randall Stanicky said last week that AcelRx was one of three small-cap companies that could be a potential takeover target, post approval of its drug.
The FDA last month rejected Intellipharmaceutics International Inc’s opioid painkiller, asking for more proof of the drug’s ability to prevent abuse.
Dsuvia is a formulation of an opioid drug that is marketed for intravenous delivery, and is meant to be administered orally in patients using the company’s proprietary delivery technology.
The FDA, in a complete response letter to AcelRx, requested for additional safety data from the drug in at least 50 patients with acute pain in trauma and ambulatory settings.
The regulator also asked for certain changes to the drug’s administration via a single-dose applicator and also recommended updating the directions for use.
AcelRx said the recommendations in the FDA’s letter were “manageable”, and it would resubmit the application for Dsuvia.
Reporting by Manas Mishra in Bengaluru; Editing by Martina D’Couto