I'm new to ELTP and am still reading through the FDA regulatory guidelines for abuse deterrent opiods. However, based on my initial readings it doesn't appear that a large classic phase III trial is required. Once again, I'm new to this area. Most of my clinical development experience was in infectious disease and oncology. Take a look at the following site.
"DR", please state how many agonist/antagonist products are on the market currently. Just because there may not be a precedent does not mean it cannot happen. Abuse deterrence as a whole is a fairly new category.
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