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That is why it can be swallowed at all, and why it behaves like a small-molecule drug: real oral absorption, first-pass liver metabolism, a huge volume of distribution (39 L/kg in mice), and off-target enzyme binding

Med., 2016, 1,643,717

This product is not a drug, food, cosmetic, or dietary supplement and has not been reviewed or approved by the FDA

Patients who regularly engage in highly stimulating activities, whether through technology use, substance consumption, or other sources of immediate pleasure, frequently report difficulty maintaining motivation for routine activities such as exercise, work tasks, or treatment adherence

Without an NDA, Medicare coverage remains off the table