Navigation Links
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 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."

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, 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

For KemPharm, Inc:   

Media / Investor Contacts:

Christal Mickle

319-665-2575

info@kempharm.com

 

 

Jason Rando / Joshua Drumm, Ph.D.

Tiberend Strategic Advisors, Inc.

212.827.0020

jrando@tiberend.com

jdrumm@tiberend.com


'/>"/>
SOURCE KemPharm, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. KemPharm, Inc. Receives Patent from the USPTO for Novel Pain Drug Candidate, KP201
2. KemPharm Advances KP201 Clinical and Commercial Program with Completion of Tablet Registration Activities
3. Inovio Pharmaceuticals Malaria DNA Vaccine Demonstrates Robust Immune Responses in Animal Models
4. Sectra Demonstrates Radiation Dose Monitoring System at AHRA and AAPM Meetings
5. New Data From Partners Center For Connected Health Demonstrates Wireless Mobile Technology Improves Patient Engagement, Outcomes
6. New Clinical Data Presented at EuroPCR Demonstrates that TriGuard Reduces Brain Lesion Volume during TAVR
7. Grifols study demonstrates higher dose of PROLASTIN-C increases levels of alpha1-PI to within normal range in patients with AAT deficiency
8. Next-Generation Circulating Tumor Cell Test Demonstrates High Efficiency and Accuracy in New Study
9. New Cardiac Electrical Biomarker Featured In Johns Hopkins Abstract Demonstrates Strong Correlation To High Sensitivity Troponin To Rule Out Acute Myocardial Ischemic Injury
10. MolecularHealth demonstrates Personalized Cancer Therapy Solutions at 2013 CeBIT
11. West Health Institute demonstrates research advances in medical device interoperability to lower the cost of health care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... NEW YORK , April 28, 2016 /PRNewswire/ ... will notably complement the company,s valve repair and ... the move also places Abbott more firmly into ... one of the fastest growing device areas, with ... to its recent report,  Advanced Remote Patient ...
(Date:4/28/2016)...  Marking its one year anniversary since launching ... risk test, Color Genomics announced a ... impact the most common hereditary cancers affecting both ... analyzes hereditary cancer risks for breast, colorectal, melanoma, ... Color Test is physician ordered and includes genetic ...
(Date:4/28/2016)... , April 28, 2016  The blood testing ... million dollars, according to Kalorama Information and The Freedonia ... immunoassays and nucleic acid testing.  The healthcare research firm ... progress in developing blood collection stations and in improving ... in Kalorama Information,s report, Blood Testing Market ...
Breaking Medicine Technology:
(Date:5/3/2016)... ... May 03, 2016 , ... California health startup Pegara ... that helps people assess their risk of developing Alzheimer’s disease. Using a questionnaire ... a “Risk Reduction Score™” that summarizes how their lifestyle choices may affect their ...
(Date:5/3/2016)... ... 03, 2016 , ... SELEX (systematic evolution of ligands ... random library of sequences depending on their attraction for a target molecule. These ... is commonly performed using filters, panning, or affinity chromatography separations. However, these traditional ...
(Date:5/3/2016)... ... May 03, 2016 , ... Elizabeth Murray has always loved walking ... her with one on her shoulder and one on her arm. But she got ... of years of mitral valve prolapse. , The valves of the heart wouldn’t close ...
(Date:5/3/2016)... , ... May 03, 2016 , ... ... has been selected by Tidelands Health, a three hospital system in South Carolina, ... constantly on the lookout for technology that enhances communication, drives workflow efficiencies and ...
(Date:5/3/2016)... ... May 03, 2016 , ... Each year, about 800,000 ... of death across the United States and account for one death every four minutes. ... or are permanently disabled. HCR ManorCare is launching a video series called “Your Brain,” ...
Breaking Medicine News(10 mins):