Nektar's Novel Opioid For Lower Back Pain Heads To US FDA Panel For Wide-Ranging Discussion
Nektar's novel opioid oxycodegol will be the first opioid analgesic taken up by an advisory committee in more than a year after the agency spent 2019 reevaluating its regulatory paradigm.
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The latest drug development news and highlights from our US FDA Performance Tracker.
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.
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an opioid and nonsteroidal anti-inflammatory reflects application of opioid benefit/risk framework described in June draft guidance.