The Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 in favor of approving Dsuvia for managing moderate-to-severe acute pain in medically supervised settings for adults.
Shares of the California-based pharmaceutical company jumped more than 20% to $4.85 in Monday pre-market trading.
READ: AcelRx Pharmaceuticals shares soar on expectation of positive FDA vote on opioid painkiller Dsuvia
The final vote will take place on November 3, taking into consideration the panel’s recommendation.
The FDA is proceeding with caution, given the rise in abuse of opioids in the US.
The regulatory agency rejected the new drug application for Dsuvia last year due to concerns about dosing and its usage directions.
Since then, AcelRx has lowered the drug’s maximum daily dose from 24 tablets to 12 tablets and provided new pooled safety analysis.
The drug’s directions were updated and a study was conducted to address concerns that the small size of the tablets would make them easy to misplace.
An analyst weighs in
Oppenheimer analyst Leland Gershell forecast that Dsuvia will be approved in November, citing the committee’s favorable vote.
However, Gershell highlighted some of the concerns brought forth by the advisory panel concerning efficacy and safety issues.
“AdComm discussion touched on several shortcomings, concerns. Among the points made, we highlight Dsuvia's dosing inflexibility, variable time to onset, lack of data in elderly patients, and absence of active comparator data,” stated Gershell.
The analyst reiterated an Outperform rating for AcelRx.
Contact Lenore Fedow at [email protected]