Esteve’s Tramadol/Celecoxib: US FDA Cites No Major Concerns, But Also No Advantages
Agency’s briefing document for 15 January review of the fixed-dose product combining an opioid and nonsteroidal anti-inflammatory reflects application of opioid benefit/risk framework described in June draft guidance.
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US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates
Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.
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.
Durect's Posimir: NDA Resubmission Raises Similar Safety Issues
How to score adverse events for Durect's surgical pain treatment could determine whether US FDA advisory committee recommends bupivacaine extended-release solution; agency questions whether Posimir's formulation may cause neurological adverse events.