NORTH LIBERTY, Iowa, May 24, 2011 /PRNewswire/ — KemPharm, Inc.
today announced positive results from a Phase 1 clinical trial of
its most advanced opioid-based drug candidate, KP201, a novel
hydrocodone prodrug for treating pain. KP201 is a new
chemical entity (NCE) composed of hydrocodone chemically bound to a
ligand.
The data confirmed that KP201 is cleaved in man as predicted,
releasing the active pharmaceutical compound hydrocodone into the
bloodstream at amounts equivalent to the reference listed drug
(RLD), Norco®. Importantly, intact KP201 could not be
detected in systemic circulation, indicating that minimal
additional studies are warranted to determine the impact of KP201
exposure in the body.
“Our findings from this first clinical trial of KP201 are as
good as we could have hoped,” stated Sven Guenther, Ph.D., Vice
President of Research at KemPharm. “The human pharmacokinetic
profile of KP201 indicates that the prodrug releases hydrocodone
efficiently and is bioequivalent to the comparator drug, supporting
a 505(b)(2) regulatory pathway for KP201 in combination with
acetaminophen. KP201 has unique physiochemical and pharmacological
attributes that deliver additional patient benefits, including
reduced potential for abuse as well as reduction or elimination of
opioid-induced constipation.”
The Phase 1 study was a single dose, three-treatment,
three-period, six-sequence, cross-over PK study in which
twenty-four healthy volunteers received oral doses of 5 mg KP201,
10 mg KP201, or 10/325 mg tablet of hydrocodone bitartrate and
acetaminophen (Norco®, RLD). The objectives of the study
included evaluation of the serum concentrations of hydrocodone,
certain metabolites, and intact KP201, as well as safety and
tolerability.
“We believe KP201 has the potential to assume sizeable market
share, given the opportunity for extended market exclusivity in
acute and chronic pain, as well as the potential to mi
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