Navigation Links
KemPharm Supports Recent FDA Recommendations for Hydrocodone-Containing Compounds and Abuse-Deterrent Opioids
Date:2/14/2013

NORTH LIBERTY, Iowa, Feb. 14, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, offered its support for the recent Food and Drug Administration (FDA) recommendations to curtail the potential abuse of opioid-based therapeutics. 

In two separate actions, on January 25, 2013, the FDA's Drug Safety and Risk Management Advisory Committee (DSaRM) voted in favor of reclassifying hydrocodone combination products from Schedule III to Schedule II under the Controlled Substances Act, and on January 10, 2013, the FDA issued a draft guidance to assist pharmaceutical companies in the development of abuse-deterrent formulations of opioids.  

Travis C. Mickle , Ph.D., president and CEO of KemPharm, commented, "Opioid-based therapeutics manage pain very well, but safe-guards and technological enhancements are needed to mitigate a clear abuse risk.  The recent FDA actions clearly speak to this issue, and KemPharm welcomes the 'call-to-arms' as we advance the development of our lead compound, KP201 (benzhydrocodone)." 

Mickle continued, "The more stringent hydrocodone classification and the opioid abuse-deterrent development guidelines will undoubtedly serve to focus our industry, but advances in technology will be the ultimate factor in effecting positive change.  This is KemPharm's rationale for developing KP201.
Benzhydrocodone, which is chemically different from hydrocodone, has demonstrated the potential to reduce drug abuse and diversion as well as prevent opioid-induced constipation (OIC), while maintaining the same pain relieving effects of current market leading drugs."

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 Q2 2014.  Recently assigned the nonproprietary name, "benzhydrocodone," by the United States Adopted Name (USAN) Council, KP201 represents the first novel pain therapy of the morphine class to be developed in a number of years with an officially recognized new chemical structure. 

About KP201
KemPharm's most advanced opioid-based drug candidate, KP201, is composed of hydrocodone chemically bound to a ligand.  The Company previously reported positive Phase 1 clinical data, which confirmed that KP201 is metabolized in man as predicted, releasing hydrocodone into the bloodstream at amounts equivalent to the reference listed drug, Norco®.  This data supports a 505(b)(2) regulatory pathway for KP201 in combination with acetaminophen. 

KP201 has 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).  Importantly, intact KP201 was not detected in systemic circulation, suggesting that minimal additional studies could be justified to determine the impact of KP201 exposure in the body. 

KemPharm has worked diligently with its manufacturing partner, Johnson Matthey , to successfully and efficiently scale up KP201 active pharmaceutical ingredient (API) in anticipation of a commercial launch.  KP201 is on track for an NDA submission to the FDA in 2014.  KemPharm is actively seeking a strategic development partner with the expertise to take KP201 through regulatory review and commercialization.

About KemPharm
KemPharm is focused on the discovery and development of 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.  KemPharm'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 primarily focused on developing candidates for pain and other central nervous system disorders. www.kempharm.com

 For KemPharm, Inc:Media / Investor Contacts:Christal Mickle

Jason Rando / Claire Sojda319-665-2575

Tiberend Strategic Advisors, Inc.info@kempharm.com

212.827.0020

jrando@tiberend.com

csojda@tiberend.com

 


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

Related medicine technology :

1. National Patient Advocate Foundation Supports 340B Drug Discount Program Review Identifying Risks to Underinsured Patients
2. Varian Medical Systems Supports Program to Tap Brain Power of Research and Development Community in Russia
3. Ameritox Leadership Supports Lawmakers, Pain Practitioners and Patients Confronting Crisis in Pain Medication Abuse
4. US Patent Granted to RBC Life Sciences for Supplement that Supports Cognitive Function
5. Amgen Backs States Efforts To Enact Biosimilar Legislation That Allows For Substitution And Supports Patient Safety
6. Novo Nordisk Supports Four San Francisco-based Organizations In Fight Against Diabetes
7. JAMA Study Demonstrates Efficacy of Life Technologies Lung Cancer Test in Detecting Early Metastases, Supports Screening for Lung Cancer
8. H. D. Smith Supports Local Hospitals, Nursing Homes, Clinics And Independent Retail Pharmacies Throughout Hurricane Sandy
9. Reproductive Medicine Associates of New York supports the ASRM endorsement of Oocyte Cryopreservation
10. Amgen Supports Assistance for Patients Affected by Hurricane Sandy
11. With Special Edition "Think Pink" Hearing Aids, The Atlanta Hearing Doctor Supports Breast Cancer Research and Better Hearing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
(Date:6/23/2016)... June 23, 2016 Any dentist who has made ... the current process. Many of them do not even offer ... difficulties and high laboratory costs involved. And those who ARE ... at such a high cost that the majority of today,s ... Dr. Parsa Zadeh , founder of Dental Evolutions Inc. ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
(Date:6/24/2016)... San Francisco, CA (PRWEB) , ... June 24, ... ... at CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has ... , self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , ...
(Date:6/24/2016)... ... ... of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum Wage’ ... 2020 and then adjusting it yearly to increase at the same rate as the median ... floor does not erode again, and make future increases more predictable. , The company is ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine ... Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor ... Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With this ...
Breaking Medicine News(10 mins):