JanOne has completed a pre-IND meeting with the FDA regarding Jan123. Jan123 is the company’s unique oral delivery of low dose naltrexone formulated to treat complex regional pain syndrome, an orphan disease of severe, debilitating impact. The Pre-IND meeting with the FDA produced a path toward formal drug application. The agency’s feedback will be used to move Jan123 toward a New Drug Application under a 505-b2 designation.
Published first on TheFly
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