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.
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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
After a COVID-19-led manufacturing halt at its India facility and a slowdown in US launches hit Strides during the first quarter of FY22, the Indian firm is trying to fight back with an acquisition of assets from Endo and a growth strategy for Stelis Biopharma’s vaccines business, led by Sputnik V.