KemPharm, Inc. Receives USAN Approval for Nonproprietary Name of Novel Pain Drug Candidate, KP201
Published: Jan 07, 2013
NORTH LIBERTY, Iowa, Jan. 7, 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 the United States Adopted Name (USAN) Council approved the use of the nonproprietary name, "benzhydrocodone," for its lead pain candidate, KP201.
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. 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).
Travis C. Mickle, Ph.D., president and CEO of KemPharm, commented, "The designation of benzhydrocodone as KP201's nonproprietary name, officially known as the USAN, is a key step in the ongoing development of KP201 and closely follows the positive feedback from the FDA on our clinical plan, which should allow us to file an NDA in the second quarter of 2014.
"Through the assignment of its own USAN, benzhydrocodone became the first novel pain therapy of the morphine class to be developed in a number of years with an officially recognized new chemical structure. These distinctions are important as there is a rapidly growing need within the pain market for a new class of opioids that provides the same therapeutic benefits, but reduces the potential for abuse and reduces or eliminates OIC."
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.
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
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Tiberend Strategic Advisors, Inc.
SOURCE KemPharm, Inc.