Another opioid pain drug, really? FDA staff sound sour on Nektar analgesic
The crisis of opioid abuse, misuse, and overdose in the United States has made the FDA a tough critic of any opioid painkiller up for review. Nektar’s analgesic, NKTR-181, is no exception.
The drug is a reduced form of the widely-abused oxycodone — it is formulated in a way that increases the half-life and diminishes the rate of entry into the brain, according to Nektar, which believes that NKTR-181’s 16 times slower entry into the brain versus oxycodone will help deter abuse — but in briefing documents posted on Friday, FDA staff did not sound convinced, highlighting that the formulation is not engineered to facilitate abuse deterrence from physical manipulation.
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