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.
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Opioid Abuse-Deterrent Formulations Could Become Prerequisite To Approval
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recommends against approval of Zogenix’s Zohydro ER as it seeks safer formulations and stricter REMS for all extended-release/long-acting opioids.
No Abuse-Resistance Claim For Endo’s Opana ER Reformulation
Endo’s Opana ER reformulation, which uses proprietary technology to deter crushing, receives approval but no labeling language on crush-resistance or abuse deterrence, according to FDA. The company says a U.S. patent to be issued Dec. 13 will protect the new formulation until November 2023.
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.