Phase 1 study of KP201 for pain management

KemPharm has begun its Phase 1 study of KP201, its abuse-deterrent formulation of hydrocodone for pain management. This trial is a single dose, crossover study in which 24 healthy volunteers will receive KP201 5mg, KP201 10mg and Norco 10/325mg (hydrocodone bitartrate and acetaminophen; Watson), each separated by a seven-day washout period. The objectives of the study include evaluation of the pharmacokinetics of KP201, hydrocodone and its active metabolite hydromorphone, as well as safety and tolerability.

KP201 is composed of hydrocodone attached to a ligand. Preclinical studies suggest that KP201 may exhibit unique abuse-deterrent properties and lower incidence of constipation based on its physicochemical and pharmacological characteristics as compared with currently approved narcotic analgesics. 

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