Navigation Links
KemPharm Advances KP201 Clinical and Commercial Program with Completion of Tablet Registration Activities
Date:4/16/2013

NORTH LIBERTY, Iowa, April 16, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today that it has completed tablet manufacturing activities as part of the clinical and commercial development program for KP201. The manufactured tablets are a fixed-dose combination of KemPharm's proprietary, non-toxic ligand attached to hydrocodone and 325 mg of acetaminophen.

KP201 is KemPharm's lead clinical candidate in development for the treatment of acute moderate to moderately severe pain. KP201, which was recently designated by the USAN council as benzhydrocodone, 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 anticipates submitting a new drug application (NDA) for KP201 to the FDA in the second quarter of 2014.

Travis C. Mickle , Ph.D., president and CEO of KemPharm, commented, "Completing the tablet registration process for KP201 is an important event as it signifies that the drug is optimally designed for continued clinical and commercial advancement. As we continue toward an NDA filing in 2014, the next milestone for KP201 is the completion of several pivotal pharmacokinetic studies in this summer.  Our expectation is this data will be the foundation of our submission to the FDA and will provide the basis upon which the safety, efficacy and abuse-deterrent properties of KP201 will be evaluated. KemPharm's goal is to develop KP201 as a first-in-class opioid-based drug that possesses the ability to reduce abuse potential and opioid-induced constipation."

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 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 / Claire Sojda

Tiberend Strategic Advisors, Inc.

212.827.0020

jrando@tiberend.com

csojda@tiberend.com


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

Related medicine technology :

1. KemPharm Supports Recent FDA Recommendations for Hydrocodone-Containing Compounds and Abuse-Deterrent Opioids
2. Rigel Advances Asthma Programs: Two Inhaled Drug Candidates Take Aim at Acute and Chronic Lung Disease
3. Selexis Lubris Partnership Advances Difficult-to-Express Protein Towards Clinic
4. Medical Imaging Information Systems Market to 2017 - Replacement of Legacy Systems and Advances in Software Present Growth Opportunities
5. Ampio Advances NCE001 Cancer Drug into Preclinical Development Following Successful Recent Financing and the Granting of Patents in USA, Canada, Europe and China
6. URAC sets standards for community pharmacy, advances dialogue about pharmacists as medication experts
7. Neurostimulation Devices Market to 2018 - Technological Advances and Robust Pipeline with Multi-Indication Potential and Non-Invasive Therapies to Drive Growth
8. Pharmaceutical Supply Chain in the US - Advances in RFID and ePedigree Systems to Limit Drug Counterfeits
9. Accelrys ELN Advances Innovation Lifecycle Management with Enhanced Biology Capabilities from Screening to Preclinical Development
10. Advances in Delivery to the Central Nervous System
11. Advances in Cosmesis Increase Amputee Acceptance of Prosthesis and Orthotics Devices, Finds Frost & Sullivan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., a ... design, and immune-engineering today announced the launch of ... development of personalized therapeutic cancer vaccines. EpiVax has ... exclusive access to enabling technologies to the new ... will lead EpiVax Oncology as Chief Executive Officer. ...
(Date:9/22/2017)... -- As the latest Obamacare repeal effort moves is debated, ... and Lindsey Graham (R-SC) medical device market ... is in an odd place.  The industry wants repeal ... on medical device sales passed along with the Affordable ... visits and hospital customers with the funding to invest ...
(Date:9/19/2017)... a venture-backed medical device company developing a non-invasive, robotically assisted, platform therapy that uses pulsed ...   ... Jim Bertolina, ... Tom Tefft ... medical device executive Josh Stopek , PhD, who has led R&D and business development ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history of ... Brink” is the creation of published author, William Nowers. Captain Nowers and his ... veteran, he spent thirty years in the Navy. Following his career as a ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
(Date:10/12/2017)... ... 2017 , ... The company has developed a suite of ... authorities worldwide. From Children’s to Adults 50+, every formula has been developed by ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, Preservative ...
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris ... of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking ... in the field of medical informatics, this prestigious award is presented to an individual ...
(Date:10/12/2017)... ... 2017 , ... Information about the technology: , Otomagnetics has ... prevention of a major side effect of chemotherapy in children. Cisplatin and carboplatin ... cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. Hearing ...
Breaking Medicine News(10 mins):