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KemPharm's KP201 Demonstrates Complete Metabolic Cleavage of Prodrug and Steady-State Pharmacokinetic Profiles for Hydrocodone, Hydromorphone and Acetaminophen
Date:8/26/2013

NORTH LIBERTY, Iowa, Aug. 26, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, today announced positive results from one of several clinical and non-clinical studies that the company is performing in preparation for its New Drug Application (NDA) for KP201 (benzhydrocodone and acetaminophen), which the company anticipates filing in the second quarter of 2014.

In a two-stage, single and multiple-dose, oral pharmacokinetic (PK) study in 26 healthy volunteers, KP201 effectively released and achieved steady-state plasma concentrations of hydrocodone, its active metabolite hydromorphone and acetaminophen.  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.

Sven Guenther, Ph.D., Vice President of Research at KemPharm, commented, "The results of this study confirm two key benefits of KP201 and of our novel prodrug approach to abuse deterrence: 1) single and multiple doses of KP201 tablets release hydrocodone effectively only upon oral administration, and 2) the prodrug itself is metabolized completely and does not reach the systemic circulation, even at the maximum daily dose.  In the coming months, we anticipate reporting additional bioavailability and bioequivalence data that we expect will affirm the unique physicochemical and pharmacological attributes of KP201."

Travis C. Mickle, Ph.D., President and CEO of KemPharm, added, "This data set is an important milestone for KemPharm as it marks one of several clinical and non-clinical studies of KP201 that we expect to complete in preparation for the filing of an NDA in the second q
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SOURCE KemPharm, Inc.
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