KemPharm Files IND for KP201/IR, a Single-Entity Benzhydrocodone HCl Immediate Release Abuse-Deterrent Prodrug for the Treatm...
October 25 2016 - 7:33AM
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 it has filed an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) to begin human clinical trials of
KP201/IR, the Company’s immediate release (IR) abuse-deterrent
hydrocodone product candidate with an acetaminophen (APAP)-free
formulation.
“The filing of the IND for KP201/IR, combined with our recent
announcement to utilize Acura Pharmaceuticals’ FDA-approved
Aversion® Technology with KP201/IR, are key steps in the
advancement of our IR abuse-deterrent opioid prodrug pipeline,”
said Travis Mickle, Ph.D., President and Chief Executive Officer of
KemPharm. “With this filing, 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).”
Dr. Mickle continued, “Today’s news, along with the recent
acceptance of the IND for KP415, our extended release (ER)
d-threo-methylphenidate (d-MPH) 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.”
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. 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 (HB). KemPharm believes that the data observed in
the A03 study, if replicated in a full human abuse potential study,
aligns with the FDA Division of Anesthesia, Analgesia, and
Addiction Products (DAAAP) criteria for achieving abuse-deterrent
product labeling, and could potentially provide KP201/IR with a
favorable regulatory pathway.
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.
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 and KP415 and the expected development program and
timelines of each product candidate, respectively. 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 June
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: |
Media
Contact: |
Jason Rando / Joshua
Drumm, Ph.D.Tiberend Strategic Advisors, Inc.212-375-2665 /
2664jrando@tiberend.comjdrumm@tiberend.com |
Daniel L. CohenExecutive
VP, Government and Public RelationsKemPharm,
Inc.202-329-1825dcohen@kempharm.com |
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