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.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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.
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.