Only thing I can think of is that the FDA wants everything covered. With the lawsuits toward pharmaceuticals due to Overdoses and the such maybe it is something FDA wants? I don't know. I can look at the guidelines FDA came out with this year and see.
However if a drug is being manufactured or made for sole purpose for pain I would think like any other drug it is for its intended uses. For instance moderate to severe pain for adults. If they were only targeting an adult demographic why would a pediatric study be necessary.
I can not see it being due to the technology. 2 drugs in which already exist. So it wasn't the drug aspect. We know how they work. Technology? It's simple. Agonist antagonist and if abused or manipulated it doesn't work. So I can't see it being anything other than either further study (worse case scenario) for pediatrics or labeling (best case scenario)
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