KemPharm, Inc.'s KP201 Demonstrates Bioequivalence Compared to Norco® in Key Pivotal Clinical Study

NORTH LIBERTY, Iowa and BOSTON, Sept. 25, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, today announced results from a second pivotal clinical study of KP201 (benzhydrocodone hydrochloride and acetaminophen) in preparation for a New Drug Application (NDA) which the company anticipates filing in the second quarter of 2014.

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 active pharmaceutical ingredient (hydrocodone), its active metabolite (hydromorphone) and acetaminophen into the bloodstream at amounts equivalent to the reference listed drug (RLD), 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 CEO 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.”

The bioequivalence clinical study, along with an overview of KP201 as it relates to the abuse- resistant opioid space, will be the subject of a presentation by KemPharm’s president and CEO, Travis C. Mickle, Ph.D., during The 7^th Annual Pain Therapeutics Summit East. Dr. Mickle’s presentation, scheduled for September 26,2013 at 2:00 pm EDT, will showcase KP201’s unique abuse-deterrent properties, which include significantly limiting narcotic exposure upon intranasal administration and intravenous injection and providing high barriers to tampering. Additionally, the presentation will highlight the potential for KP201 to prevent or reduce opioid-induced constipation.

Dr. Mickle continued, “The 7^th Annual Pain Therapeutics Summit East is an ideal forum to present the bioequivalence data and showcase KP201 as a potential ‘next-generation’ therapy for pain management. I greatly look forward to presenting what is very compelling data on KP201 and its ability to reduce abuse potential and opioid-induced constipation.”

About KemPharm

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, KP606, its oxycodone 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.