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.
You may also be interested in...
Many prescribers don’t read drug labels, meaning they may not see the new warnings and recommendations in the immediate- and extended-release opioid labels, says Brandeis’ Kolodny. Meanwhile, as the Senate advances a bill that would allow comparative review of opioids, they make up a smaller amount of the drug development landscape.
Avenue Therapeutics seems unlikely to get advisory committee support for its opioid analgesic over the agency’s conclusion that the drug’s ‘minimal benefit’ is outweighed by a potential risk from its delayed onset of pain relief. FDA has issued two complete response letters and denied Avenue’s first request for a formal dispute resolution.
Keeping Track: US FDA Clears Opioid Seglentis And Anti-Opioid Zimhi; CRLs For Revance, United; Delay For UCB
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker