A panel of expert advisers to the U.S. Food and Drug Administration recommended AcelRx Pharmaceuticals Inc.'s under-the-tongue opioid Dsuvia for approval.
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee decided in a 10-3 vote that the regulator should approve the drug, although the agency is not bound by the committee's decision.
Dsuvia is a sufentanil sublingual tablet designed to reduce dosing errors that can be associated with intravenous drugs. The noninvasive single-dose applicator, administered in a medically supervised setting, treats patients with moderate to severe acute pain.
Shares of the Redwood City, Calif.-based company jumped Oct. 10 when the committee said the drug was safe and effective based on resubmitted data.
The FDA had initially rejected the drug based on concerns regarding the maximum dosage and the risk of misplaced tablets. AcelRx subsequently reduced the maximum dose from 24 tablets to 12 and modified the directions for use to prevent misplaced pills. The company also performed another study to determine human factors in potential misuse.
The regulator will issue a final determination by Nov. 3.
"We are pleased with the advisory committee's recommendation to approve Dsuvia as a treatment in medically supervised settings for adults experiencing moderate to severe acute pain," AcelRx co-founder and chief medical officer Pamela Palmer said in a press release. "We look forward to continued collaboration with the FDA on the application as we believe Dsuvia represents an important non-invasive acute pain management option with potential to significantly improve the current standard of care."
The drug was approved by the European Commission in June and is marketed as Dzuveo in Europe.