FDA Advisory Committees Recommend Teva’s Vantrela

Two advisory committees recommended the approval of Teva Pharmaceutical’s Vantrela for pain management with abuse-deterrent labeling.

The committees voted 14-3 to recommend approving the extended-release product for managing severe pain that requires daily opioid treatment in cases when alternative therapies are inadequate.

Committee members largely agreed that the candidate demonstrated a lower increase in pain compared to the placebo in Teva’s Study 3103. Those who voted against approval expressed concerns about introducing another high-dose opioid given the opioid-abuse epidemic.