KemPharm Shows Bioequivalence with KP201

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 KP201 was metabolized completely and that no systemic prodrug exposure was observed in any subject at any time point during the study. KP201 was also shown to be safe and well tolerated by the opioid-naive volunteers in the study.

Travis C. Mickle, Ph.D., president and chief executive officer of KemPharm, commented, “Demonstrating bioequivalence to Norco, combined with the previously reported ‘steady-state’ data, allows us to assert with confidence that KP201 produces the same pharmacokinetic and therapeutic effect as currently approved hydrocodone medications with the added benefit of abuse deterrence and reduction of opioid-induced constipation. Based on our prior discussions with the FDA, these data sets will be the foundation of the NDA for KP201 and will be the key criteria assessed during its review. We continue to be extremely pleased with the clinical results for KP201 and look forward to reporting additional, confirmatory studies in the coming months as we target an NDA filing in the second quarter of 2014.”