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

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 submissi
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SOURCE KemPharm, Inc.
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