Navigation Links
KemPharm, Inc. Announces Positive Results from Phase 1 Trial of KP201 for Pain
Date:5/24/2011

NORTH LIBERTY, Iowa, May 24, 2011 /PRNewswire/ -- KemPharm, Inc. today announced positive results from a Phase 1 clinical trial of its most advanced opioid-based drug candidate, KP201, a novel hydrocodone prodrug for treating pain.  KP201 is a new chemical entity (NCE) composed of hydrocodone chemically bound to a ligand.

The data confirmed that KP201 is cleaved in man as predicted, releasing the active pharmaceutical compound hydrocodone into the bloodstream at amounts equivalent to the reference listed drug (RLD), Norco®.  Importantly, intact KP201 could not be detected in systemic circulation, indicating that minimal additional studies are warranted to determine the impact of KP201 exposure in the body.

"Our findings from this first clinical trial of KP201 are as good as we could have hoped," stated Sven Guenther, Ph.D., Vice President of Research at KemPharm. "The human pharmacokinetic profile of KP201 indicates that the prodrug releases hydrocodone efficiently and is bioequivalent to the comparator drug, supporting a 505(b)(2) regulatory pathway for KP201 in combination with acetaminophen. KP201 has unique physiochemical and pharmacological attributes that deliver additional patient benefits, including reduced potential for abuse as well as reduction or elimination of opioid-induced constipation."

The Phase 1 study was a single dose, three-treatment, three-period, six-sequence, cross-over PK study in which twenty-four healthy volunteers received oral doses of 5 mg KP201, 10 mg KP201, or 10/325 mg tablet of hydrocodone bitartrate and acetaminophen (Norco®, RLD).  The objectives of the study included evaluation of the serum concentrations of hydrocodone, certain metabolites, and intact KP201, as well as safety and tolerability.

"We believe KP201 has the potential to assume sizeable market share, given the opportunity for extended market exclusivity in acute and chronic pain, as well as the potential to minimize opioid-induced constipation," commented Travis Mickle, Ph.D., President and Chief Executive Officer at KemPharm.  "We expect to be in a position to file an NDA for KP201 within the next 18 to 24 months, allowing us to position the product in full compliance with the FDA's recent decision to limit acetaminophen in prescription products."

About KP201

KP201, KemPharm's lead clinical prodrug candidate for the treatment of pain, is composed of hydrocodone attached to a ligand.  Preclinical studies suggest that KP201 may exhibit unique abuse deterrent properties and lower incidence of constipation based on its physicochemical and pharmacological characteristics as compared with currently approved narcotic analgesics.  KemPharm believes it may be able to use the 505(b)(2) regulatory pathway for a more rapid development timeline.

About KemPharm, Inc.

KemPharm, Inc. is focused on the discovery and development of new chemical entities (NCEs) to treat serious medical conditions through its proprietary and broadly applicable LAT prodrug approach.  KemPharm utilizes its LAT prodrug technology to generate improved versions of FDA approved drugs.  The Company's business strategy includes seeking strategic development partners following rapid clinical proof of concept demonstration in a Phase 1 trial.  KemPharm also plans to explore discovery stage alliances with industry leaders, leveraging its prodrug know-how and LAT technology.  KemPharm is developing candidates for ADHD, pain, other central nervous system disorders. www.kempharm.com

Forward Looking Statements and Information

This release contains forward-looking statements which are not based upon historical fact, including, without limitation, "will," "should," "expect," "anticipate," "plan," "predict," "believe," "may" and "project." Such statements, including statements relating to developments, progress, timelines, plans of our clinical and preclinical programs, and potential benefits of KemPharm Inc.'s product candidates, involve various assumptions, known and unknown risks, and uncertainties which may cause actual results or events to be materially different and adverse from those expressed in or implied by the forward-looking statements.  Such assumptions, risks and uncertainties may relate to difficulties or delays in discovery, development, testing, and regulatory approval of the company's product candidates, results that are inconsistent with preclinical results, unexpected adverse side effects, or inadequate therapeutic efficacy of the product candidates.  The forward-looking statements in this release speak only as of this date, and KemPharm disclaims any obligation to update publicly any forward-looking statement to reflect the occurrence of events or circumstances after the date hereof.

Contacts:
KemPharm, Inc.
Kate Holt, Ph.D.
319-665-2575
E-mail: info@kempharm.com

The Ruth Group (on behalf of KemPharm)
Jason Rando/Eric Reiss (media)
(646) 536-7025/7032
jrando@theruthgroup.com/ereiss@theruthgroup.com

Joshua Drumm (investors)
(646) 536-7006
jdrumm@theruthgroup.com


'/>"/>
SOURCE KemPharm, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. KemPharm, Inc. Receives Notice of Issuance From USPTO on Patent Protecting Companys ADHD Prodrug Technology
2. KemPharm, Inc. Receives Notice of Issuance from USPTO on Second Patent Protecting Companys ADHD Prodrug Technology
3. KemPharm, Inc. Announces Plans to Launch KP106 as First Oral Film Dosage Form for ADHD
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
6. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
7. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
8. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
9. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
10. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
11. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... -- HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform therapy ... team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led R&D ...
(Date:9/18/2017)... Mich. , Sept. 18, 2017  PMD Healthcare ... Specialty Pharmacy of Kalamazoo, Mich. , ... hub service that expedites and streamlines patient and provider ... PD 2.0, and wellness management services.  ... device used to measure lung function for a variety ...
(Date:9/13/2017)... 2017   OrthoAtlanta has been named the official ... Committee (AFHC) for the 2018 College Football Playoff (CFP) National ... Mercedes-Benz Stadium in Atlanta, Georgia . OrthoAtlanta ... In" campaign, participating in many activities leading up to, and ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... SAN LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... with Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for ... mean is the 90-day elimination period, when the family pays for care, is often ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor ... on sciatica in a new episode of "Success Files," which is an award-winning ... innovation and investigates each subject in-depth with passion and integrity. , Sciatica occurs ...
(Date:10/12/2017)... Francisco, CA (PRWEB) , ... October 12, 2017 ... ... Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent ... apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, ... post-acute health care, have expanded their existing home health joint venture through an ... has been operating a joint venture home health company with Asante, delivering clinically ...
(Date:10/12/2017)... ... ... On Saturday, October 21, the Health & Wellness Center at Florida Hospital ... for the American Heart Association Heart Walk. Teams of up to 10 people can ... their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. on Saturday, ...
Breaking Medicine News(10 mins):