Navigation Links
KemPharm Completes Successful End-of-Phase 2 Meeting with FDA
Date:11/1/2013

NORTH LIBERTY, Iowa, Nov. 1, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today the successful completion of an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) for its lead pain candidate, KP201 (benzhydrocodone hydrochloride and acetaminophen).  Based on the results of the meeting, KemPharm believes the completed and ongoing clinical, non-clinical and CMC development programs will allow for the submission of a New Drug Application (NDA) for KP201 in the third quarter of 2014.

During the meeting, representatives from the FDA reviewed KemPharm's current portfolio of data for KP201, including the recently completed bioequivalence and "steady-state" pivotal clinical studies.  It was determined that the final data package, as proposed by KemPharm, would support a potential 505(b)(2) filing pathway without any additional efficacy, toxicology or safety data being required.

Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "The positive feedback we received from the Agency re-affirms prior discussions related to our clinical and non-clinical program for KP201 and our plan to pursue an NDA via the 505(b)(2) pathway. Based on their advice, we are extremely confident in our plan to submit an NDA by the third quarter of 2014 and seek potential approval of the first novel pain therapy of the morphine class to be developed in a number of years with an officially recognized new chemical structure."

KP201 is in development for the treatment of acute moderate to moderately severe pain. 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).

Mickle continued, "The next clinical milestone for KP201 will be the completion of oral and intranasal abuse liability studies in the first quarter of 2014.  These studies will be important indicators of KP201's unique abuse-deterrent capabilities, which we believe are unlike any prescription opioid on the market or in development."

About KemPharm

KemPharm is abiopharmaceutical 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 third 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

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 biology technology :

1. KemPharm, Inc. Appoints Gordon K. "Rusty" Johnson as Chief Operating Officer and Chief Financial Officer
2. KemPharms KP201 Featured at the International Conference on Opioids
3. Micropharma completes development of first microbiome clinical lab test using digital PCR technology
4. Syneron Medical Completes and Summarizes the Multi-site Clinical Study Agreed Upon with FDA for the UltraShape Contour I
5. AIS (American Internet Services) Completes Audit for Title 21 CFR Part 11 Compliance
6. Relmada Therapeutics Inc. Completes $8.0 Million Capital Raise In Series A Financing
7. VIVEX BIOMEDICAL Successfully Completes $7.6 Million Round of Financing
8. Boston Scientific Completes $1.05 Billion Senior Notes Offering
9. SureClinical Completes FDA 21 CFR Part 11 Compliance Audit of SureTrial® eTMF Cloud Edition
10. Eurofins MWG Operon Quality Assurance Group Completes ISO Certifications for Their New Overnight Sequencing Lab
11. Oligomerix, Inc. Completes Series B Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... , ... September 19, 2017 , ... ... largest group of funded early-stage tech companies. “Grit” author Angela Duckworth and her ... joining the ic@3401 community is Cooley, an international law firm with decades of ...
(Date:9/19/2017)... ... 2017 , ... The new and improved Oakton® pocket testers, from Cole-Parmer, stand ... with a new cap design that is versatile, functional and leakproof. They are ideal ... test water quality. , The Oakton pocket testers have many user-friendly and functional features. ...
(Date:9/19/2017)... , Sept. 19, 2017 ValGenesis Inc., ... (VLMS) is pleased to announce the strategic partnership with ... provide clients with validation services using the latest technology ... VTI will provide clients with efficient and cost-effective validation ... marketing partner for the ValGenesis VLMS system. ...
(Date:9/19/2017)... ... 2017 , ... Molecular Devices, LLC, a leader in protein ... the CloneSelect™ Single-Cell Printer™ in North America. This novel system utilizes sophisticated ... documentation of monoclonality for use in cell line development. , Clonal cell ...
Breaking Biology Technology:
(Date:3/27/2017)... March 27, 2017  Catholic Health Services (CHS) ... Systems Society (HIMSS) Analytics for achieving Stage 6 ... sm . In addition, CHS previously earned a ... using an electronic medical record (EMR). ... level of EMR usage in an outpatient setting.  ...
(Date:3/23/2017)... PUNE, India , March 23, 2017 The report ... Equipment, Touchless Biometric), Industry, and Geography - Global Forecast to 2022", published by ... growing at a CAGR of 29.63% between 2017 and 2022. ... ... Logo ...
(Date:3/22/2017)... 2017 Optimove , provider of ... such as 1-800-Flowers and AdoreMe, today announced two ... Replenishment. Using Optimove,s machine learning algorithms, these features ... replenishment recommendations to their customers based not just ... customer intent drawn from a complex web of ...
Breaking Biology News(10 mins):