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chipmuki1234567on Mar 05, 2018 11:52pm
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RE:RE:RE:RE:RE:Dr wallace - Resume summary
RE:RE:RE:RE:RE:Dr wallace - Resume summary Why NicOx Ran Into an FDA Stone Wall With Its "Safer" Arthritis Drug
NicOx completed clinical trials in more than 6,700 patients, and three Phase III trials met their endpoints of improving pain relief compared to placebo. FDA briefing documents released earlier this week and an expert panel review yesterday seemed convinced on that point.
The problem is, that's not enough. That just puts naproxcinod on even footing with the myriad other NSAIDs on the market, many of which are cheap generics or over-the-counter medicines. NicOx needs naproxcinod's label to say the drug is safer than all the rest, and neither the FDA nor its advisors seemed convinced on that point.
The FDA was so harsh on NicOx's claim of better gastrointestinal tolerability and fewer ulcers that the company already said yesterday it would pull that language out of its proposed label. The blood pressure lowering claim is the more important one, but the agency said those effects were seen only at the drug's peak and weren't consistent enough in the longer term. The FDA also questioned whether or not blood pressure in older patients dipped too low at the peak, and they cited problems with NicOx's analysis showing that naproxcinod is not inferior to naproxen.
https://www.cbsnews.com/news/why-nicox-ran-into-an-fda-stone-wall-with-its-safer-arthritis-drug/