|[November 19, 2012]
KemPharm, Inc. Receives Positive Feedback from FDA on KP201 Clinical Plan
NORTH LIBERTY, Iowa --(Business Wire)--
KemPharm, Inc., a clinical stage biopharmaceutical company focused on
the discovery and development of new, safer therapies to treat pain,
announced today a successful Type B meeting with the Food and Drug
Administration (FDA) for its lead pain candidate, KP201. The meeting was
held to obtain input from the Agency in regard to the remaining clinical
and non-clinical program required for submission of a new drug
application (NDA) for KP201.
KemPharm presented to the FDA its clinical and non-clinical data that
have been completed to date along with its remaining proposed studies in
support of a potential 505(b)(2) filing pathway.
"Based on the discussion KemPharm had with the Agency, we are confident
that KP201 will be able to proceed under a 505(b)(2) filing which will
allow for a greatly shortened development timeline compared to most new
chemical entities," stated Dr. Sven Guenther, Vice President of
Research. "Additionally, the remaining studies, both clinical and
non-clinical, along with manufacturing, represent a fairly low
KP201 is in development for the treatment f acute moderate to
moderately severe pain with a new drug application on target to be filed
in Q2 2014.
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
during a Phase I study, 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 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. 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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