Trials & Filings

KemPharm Shows Bioequivalence with KP201

Pain treatment releases, metabolizes equivalent to reference drug

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

KemPharm, Inc. received positive results from its second pivotal study of KP201 in preparation for the NDA the company anticipates filing in 2Q14. In a single-dose, two-period, two-treatment, two-sequence, two-way crossover, oral pharmacokinetic (PK) study in 30 healthy volunteers, KP201 effectively released the API (hydrocodone), its active metabolite (hydromorphone) and acetaminophen into the bloodstream at amounts equivalent to the reference listed drug, Norco. The data also confirmed that KP...

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