AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) is standing by the safety, efficacy and medical need for its opioid pain treatment drug Dsuvia in the wake of its approval vote by a US Food and Drug Administration advisory committee.
Earlier this month, the Anesthetic and Analgesic Drugs Products Advisory Committee voted 10-3 in favor of approving Dsuiva for managing moderate-to-severe acute pain in medically supervised settings for adults.
The final vote on the drug will take place on November 3, taking into consideration the panel’s favorable recommendation.
“We appreciate the thoughtful and thorough discussion among the 13 committee members, as well as the forum for public commentary,” AcelRx said in a statement. “AcelRx is committed to continued collaboration with the FDA on the new drug application for Dsuvia.”
READ: AcelRx Pharmaceuticals shares soar following FDA advisory committee’s approval vote for Dsuvia
Developed in collaboration with the Department of Defense, Dsuvia represents a non-invasive alternative to IV opioids, the current standard of care for acute pain management.
The FDA is proceeding with caution when it comes to Dsuvia’s approval, 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.
AcelRx shares slipped 2.2% to $3.55 in Monday’s pre-market session.
Contact Ellen Kelleher at [email protected]