KemPharm's KP201 Demonstrates Complete Metabolic Cleavage of Prodrug and Steady-State Pharmacokinetic Profiles for Hydrocodone, Hydromorphone and Acetaminophen Clinical Study Also Indicates No Systemic Prodrug Exposure Over Multiple-Day Dosing at Maximum Daily Dose
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 quarter of 2014. As the safety, tolerability and PK performance of KP201 is further established, we believe the prodrug has the potential to fulfill a significant therapeutic and market need as a first-in-class opioid-based prodrug that possesses the ability to reduce abuse potential and opioid-induced constipation."
KemPharm is a biopharmaceutical company focused on the discovery and development of new chemical entities (NCEs) to treat serious medical conditions through its proprietary and broadly applicable Ligand Activated Therapy (LAT) approach. The company utilizes its LAT technology to generate improved prodrug versions of FDA approved drugs in the high needs areas of pain, ADHD and other CNS diseases. KemPharm's lead clinical candidate, KP201, is in development for the treatment of acute, moderate to moderately severe pain with a new drug application (NDA) expected to be filed in the second quarter of 2014. Composed of hydrocodone chemically bound to a ligand, KP201 offers unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation (OIC). KemPharm's pipeline is also highlighted by KP511, its hydromorphone prodrug for pain, and KP415, a prodrug of methylphenidate for the treatment of ADHD. For more information on KemPharm, please visit the company's website at www.kempharm.com
SOURCE KemPharm, Inc.