KemPharm Receives Clearance from FDA to Initiate Clinical Program for KP201/IR, a Single-Entity Benzhydrocodone HCl Immediate...
November 29 2016 - 7:30AM
KP201/IR could be the first single entity
(APAP-free), IR hydrocodone product for pain analgesia with
abuse-deterrent properties
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs, today announced that its Investigational New
Drug (IND) application for KP201/IR has been accepted by the U.S.
Food and Drug Administration (FDA). KP201/IR, KemPharm’s co-lead
product candidate, is a single-entity benzhydrocodone HCl immediate
release abuse-deterrent prodrug for the treatment of acute
pain. KemPharm expects to conduct human clinical trials of
KP201/IR in 2017.
“We are very pleased that the FDA has accepted
our IND request for KP201/IR. This, along with the recent
acceptance of the IND and initiation of human clinical trials for
KP415, our extended release d-threo-methylphenidate product
candidate for the treatment of attention deficit hyperactivity
disorder (ADHD), means that our two lead product candidates are
meeting the early regulatory milestones we have established for
them,” said Travis Mickle, Ph.D., President and Chief Executive
Officer of KemPharm. “With this clearance, we intend to
initiate human clinical trials of KP201/IR in the first half of
2017 and remain on target for a potential submission in 2018 of the
KP201/IR New Drug Application (NDA).”
KP201/IR has the potential to reach the market
as the first abuse-deterrent IR hydrocodone product, as well as the
first IR hydrocodone-related product without acetaminophen
(APAP). KemPharm believes KP201/IR is well-positioned to take
advantage of data generated from the Apadaz™ development program,
including data from the KP201.A03 study, which compared hydrocodone
exposure following insufflation of benzhydrocodone HCl (KP201) vs.
hydrocodone bitartrate. KemPharm believes that the data
observed in the KP201.A03 study, if replicated in a full human
abuse potential study, may align with the FDA Division of
Anesthesia, Analgesia, and Addiction Products criteria for
achieving abuse-deterrent product labeling.
About KemPharm
KemPharm is a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs to treat serious medical conditions through
its Ligand Activated Therapy (LAT) platform technology.
KemPharm utilizes its LAT platform technology to generate improved
prodrug versions of FDA-approved drugs in the high need areas of
pain, ADHD and other central nervous system (CNS) disorders.
KemPharm’s co-lead clinical development candidates are KP415, an
extended-release (ER) prodrug of methylphenidate for the treatment
of attention deficit hyperactivity disorder (ADHD), and KP201/IR,
an acetaminophen (APAP)-free formulation of the company’s immediate
release (IR) abuse deterrent hydrocodone product, KP201. For
more information on KemPharm and its pipeline of prodrug product
candidates visit www.kempharm.com.
Caution Concerning Forward Looking
StatementsThis press release may contain forward-looking
statements made in reliance upon the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements include all statements that do not
relate solely to historical or current facts, and can be identified
by the use of words such as “may,” “will,” “expect,” “project,”
“estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,”
“continue” or the negative versions of those words or other
comparable words. These forward-looking statements include
statements regarding the expected features and characteristics of
KP201/IR, the expected development timeline of KP201/IR and KP415,
and potential submission of an NDA for KP201/IR. These
forward-looking statements are not guarantees of future actions or
performance. These forward-looking statements are based on
information currently available to KemPharm and its current plans
or expectations, and are subject to a number of uncertainties and
risks that could significantly affect current plans. Actual results
and performance could differ materially from those projected in the
forward-looking statements as a result of many factors, including,
without limitation, the risks and uncertainties associated with:
KemPharm's financial resources and whether they will be sufficient
to meet KemPharm's business objectives and operational
requirements; results of earlier studies and trials may not be
predictive of future clinical trial results; the protection and
market exclusivity provided by KemPharm's intellectual property;
risks related to the drug discovery and the regulatory approval
process; the impact of competitive products and technological
changes; and the FDA approval process under the Section 505(b)(2)
regulatory pathway, including without limitation any timelines for
related approval. KemPharm's forward-looking statements also
involve assumptions that, if they prove incorrect, would cause its
results to differ materially from those expressed or implied by
such forward-looking statements. These and other risks concerning
KemPharm’s business are described in additional detail in
KemPharm's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016, and KemPharm’s other Periodic and Current
Reports filed with the Securities and Exchange Commission.
KemPharm is under no obligation to (and expressly disclaims any
such obligation to) update or alter its forward-looking statements,
whether as a result of new information, future events or
otherwise.
Investor Contacts:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
Media Contact:
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
dcohen@kempharm.com
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