Opioid Post-marketing Studies: Can Sponsors Work Well Together Again?
FDA wants to get a handle on how long-term use of long-acting pain killers relates to abuse and misuse; the agency also is requiring labeling changes that remove “moderate” pain from the products’ indication.
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While Belbuca represents a new formulation, it does not contain the abuse-deterrent properties that FDA has been encouraging.
REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.