KemPharm, Inc. Advances KP201 Clinical Program with Initiation of Human Abuse Liability and Human Gastrointestinal Motility Trials

Studies to Investigate Ability of KP201 to Deter Abuse and Reduce Opioid-Induced Constipation

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Sep 08, 2014, 08:10 ET

CORALVILLE, Iowa, Sept. 8, 2014 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today the initiation of clinical trials of KP201 designed to investigate the drug candidate's ability to deter abuse and reduce opioid-induced constipation. KP201 (benzhydrocodone hydrochloride and acetaminophen) is KemPharm's hydrocodone prodrug in development for acute moderate to moderately severe pain.

The human abuse liability program will consist of three separate studies comparing KP201 with Norco^®, focusing on key abuse-deterrence criteria as specified by the Food and Drug Administration (FDA). The first, a non-clinical study with data expected prior to year-end 2014, will evaluate KP201's tamper resistance (whether the active ingredient can be extracted physically or chemically). The second and third, both clinical trials, are designed to measure the likability of KP201, as compared to Norco^®, when abused orally at levels greater than the recommended dosage and intranasally (ground into a powder and inhaled). Data from the oral and intranasal abuse likability trials are expected in the first half of 2015. Norco^®is a combination of hydrocodone and acetaminophen approved for marketing by the FDA.

The human gastrointestinal (GI) motility trial of KP201, which will also compare KP201 to Norco^®, will investigate differences in the GI motility of trial subjects, as measured by an orally administered, wireless data transmitting capsule, after the separate oral administration of each of the two drugs. The trial will evaluate KP201's potential to reduce or eliminate opioid-induced constipation. This clinical investigation builds upon preclinical data in dogs and rats that suggest the unique prodrug pharmacology of KP201 is able to bypass the μ-opioid receptor in the small intestine, which when activated is believed to play a role in the constipation side-effect common to opioid medications. The study will enroll 40 subjects, with completion also expected in the first half of 2015.

Travis C. Mickle, Ph.D., President and CEO of KemPharm, stated, "The initiation of the human abuse liability and human GI motility trials is a significant advancement in the KP201 clinical program, and we look forward to completing all of the studies by the first half of 2015. If the data are favorable, these studies should help to differentiate KP201 from other opioid therapeutics on the market, first by potentially enabling KemPharm to claim three of the four tiers of abuse-deterrence on its label, if approved by the FDA, with the goal of achieving the fourth tier post-approval, and second by further supporting preclinical evidence which suggests that the proprietary chemical structure of KP201 may avoid receptors in the digestive system that otherwise cause constipation when activated by today's opioid-based medications."

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. For more information on KemPharm, please visit the company's website at www.kempharm.com.

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SOURCE KemPharm, Inc.