DEA Scheduling Delays Can Be Reduced With Early Studies, Frequent Sharing
Early interactions with FDA and the Drug Enforcement Administration may help drug sponsors avoid a long lag time between NDA approval and controlled substance scheduling, industry and agency experts said at the Food and Drug Law Institute’s annual meeting.
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Naloxegol is currently a Schedule II controlled substance due to its structural similarity to another compound; AstraZeneca seeks descheduling of the constipation drug, which labeling states poses no risk of abuse or dependency.
Opioid Sponsors To Get Help Developing Abuse-Resistant Products From FDA, NIH
Additional research into abuse-deterrent and non-addictive drug formulations is expected as part of the Obama Administration’s prescription drug abuse plan, some of which already is under way.
Tamper-Resistance Could Allow New Opioid Formulations To Differentiate Themselves
A claim for tamper-resistance rather than broad abuse-deterrence appears to be the immediate path forward for companies seeking to differentiate a new opioid product by its ability to impede recreational use.