Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Opioid-Sparing Hopes, Efficacy Worries Drive Inconclusive Advisory Cmte. On Durect's Posimir
US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.
One Loss, One Tie: US FDA Panels Prove Difficult For Opioid Sponsors Intellipharmaceutics, Esteve
Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
Nektar's Novel Opioid Unanimously Rejected by US FDA Advisory Cmte.
But more data on abuse potential and efficacy could offer path for forward for oxycodegol even after the FDA product-specific advisory committee meeting for an opioid analgesic in more than a year goes very badly for the sponsor.