Dive Brief:
- An FDA advisory panel voted 14-3 Tuesday to recommend Teva's Valentra ER painkiller for approval.
- The opioid painkiller lasts 12 hours and also includes abuse deterrents.
- The support comes as opioid painkillers come under fresh scrutiny for abuse.
Dive Insight:
This is a tough time to get regulatory approval for a high-dose opioid painkiller, and there is some question about the true effectiveness of Valentra's abuse deterrents, but the vote wasn't close and the FDA typically follows the rulings of its advisory panels.
Reuters, citing an estimate from Mizuho Securities USA, reports Vantrela ER could generate $130 million in annual by 2020. Today, the panel will consider another high-dose opioid -- this one from Pfizeer.