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Because this is a recently recognized adverse effect, treatment strategies are drawn from case report outcomes, general allodynia management guidelines, and clinical experience with neuropathic pain

[DOI] [PubMed] [Google Scholar] 89

It is precisely because the liver questions are the hardest and slowest to answer that the FDAs Breakthrough Therapy designation in this indication is meaningful for the development timeline, even though it changes nothing about the drugs current unapproved status