The senator noted that the product, which is designed for use in medically-supervised settings, consists of sufentanil – an opioid that is up to 10 times as powerful as fentanyl.
“Even in the midst of the worst drug crisis our nation has ever seen, the FDA once again is going out of its way to approve a new super-charged painkiller that would only worsen the opioid epidemic. It makes no sense to approve an opioid painkiller that has no benefits over similar medications and against the advice of experts. I call on the FDA to reject the vote of the advisory committee and stop the approval of this dangerously unnecessary opioid medication,” Markey said in prepared remarks.
The senator’s remarks came just days after an advisory committee for the FDA voted 10-3 to recommend approval for Dsuvia. The agency is slated to make a final decision by Nov. 3.
In a statement, Redwood City, Calif.-based AcelRx said it stands by the safety and efficacy of its therapy.
“Developed in collaboration with the Department of Defense, Dsuvia potentially represents an important non-invasive, rapidly acting alternative to IV opioids, the current standard of care for acute pain management in medically supervised settings,” the company said.
AcelRx’s Dsuvia sufentanil sublingual tablets are administered by healthcare professionals using a single-dose applicator. The company maintains that by delivering sufentanil sublingually, the drug’s pharmacokinetic profile avoids the high peak plasma levels and short duration of action associated with intravenous administration.
Dsuvia, known outside the U.S. as Dzuveo, was approved for the European market in June this year.